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Long-term effectiveness of a patient and family pain education program on overcoming barriers to management of cancer pain
Pain 122 (2006) 271–281 www.elsevier.com/locate/pain
Long-term effectiveness of a patient and family pain education program on overcoming barriers to management of cancer pain Chia-Chin Lin
a,*
, Pi-Ling Chou b, Shang-Liang Wu c, Yue-Cune Chang d, Yuen-Liang Lai e,f,g
a
Graduate Institute of Nursing, Taipei Medical University, Taipei, Taiwan b Shu-Zen College of Medicine and Management, Kaohsiung, Taiwan c Bureau of Health Promotion, Department of Health, Taiwan d Department of Mathematics, Tamkang University, Taiwan e Hospice and Pallative Care Center, Mackay Memorial Hospital, Taiwan f Center of General Education, National Yang-Ming University, Taiwan g School of Medicine, Taipei Medical University, Taiwan
Received 3 December 2004; received in revised form 22 December 2005; accepted 26 January 2006
Abstract The purpose of this research was to investigate the effectiveness of a patient and family pain education program on reducing cancer patients’ and their families’ barriers to (i.e., concerns or misconceptions about) cancer pain management, on increasing patients’ adherence to a prescribed analgesic regimen, and on decreasing pain intensity and pain interference with daily life. An experimental and longitudinal design was used. The experimental group consisted of 31 pairs of cancer outpatients and their family carers, while the control group consisted of 30 patient–family pairs (N = 122). Patients and their family carers in the experimental group simultaneously received a pain management education program. Both groups had pretest data collection and after-test follow-ups on the second and fourth weeks at the outpatient clinics. Comparisons between those two groups were made using the Generalized Estimating Equations (GEE) method. Results revealed that at both the second and fourth weeks, patients and family carers in the experimental group showed a significantly greater reduction in barrier scores than did patients and family carers in the control group. At the second and fourth weeks, patients in the experimental group reported significantly better adherence to a scheduled analgesic regimen than did patients in the control group. In the fourth week, patients in the experimental group reported significantly lower levels of worst pain intensity and pain interference than did patients in the control group. This research provides evidence of the effectiveness of a patient and family pain education program. Ó 2006 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. Keywords: Cancer pain; Pain management; Pain education program; Barriers to pain management; Family
1. Introduction The hesitancy among Taiwanese cancer patients and their family carers to report pain and to use analgesics *
Corresponding author. Tel.: +886 2 23776229; fax: +886 2 23772842. E-mail address: [email protected] (C.-C. Lin).
is a barrier to optimal cancer pain management (Lin and Ward, 1995; Lin, 2000; Lin et al., 2000). If family carers misunderstand the effects of analgesics, they may be hesitant to administer these drugs and pain reports will not be accurate (Lin and Ward, 1995; Lin, 2000). Most studies have focused only on patient education and few have supported the effectiveness of pain education programs in reducing misconceptions about analgesics,
0304-3959/$32.00 Ó 2006 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.pain.2006.01.039
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increasing knowledge about pain, or increasing compliance in the administration of pain medication (Rimer et al., 1987; Ferrell et al., 1994; de Wit et al., 1997). No study has involved both patients and family carers in Taiwan. Therefore, the purposes of this study were to investigate the long-term effectiveness of a simultaneous Taiwanese patient and family pain education program. A recent study using the Barriers Questionnaire-Taiwan form identified nine common concerns of Taiwanese cancer patients and their family carers about reporting pain and using analgesics (Lin, 2000). These concerns included the belief that medicine cannot really control pain, the fear of addiction, a desire to be a ‘‘good patient’’ by not complaining about pain, the fear that one’s physician will be distracted from treating the disease to controlling the pain, the concern that increasing pain signifies disease progression, the belief that medication should be saved in case the pain gets worse, the concern about side-effects of analgesics, the belief that the pain is caused by God or Karma and must be endured, and the concern that pain medications are better given as needed instead of on an around-the-clock scheduled basis. These concerns were held by almost all patients and family carers and contributed to their reluctance to report pain and to use analgesics, which, in turn, contributed to inadequate pain control (Lin, 2000). Past studies have provided some evidence about the effectiveness of pain education programs (Rimer et al., 1987; Ferrell et al., 1993, 1994, 1995; de Wit et al., 1997; Ferrell and Rivaera, 1997; Chelf et al., 2001; Oliver et al., 2001). The importance of evaluating patients’ and their family members’ experience with pain expression and of establishing the role their attitudes play in the correct administration of analgesics in pain management has been studied (Miaskowski et al., 1997; Lin, 2000; Redinbaugh et al., 2002). However, the contribution of family carers to pain education and management of cancer pain has not been well documented. In addition, most researchers have investigated the short-term effects of pain management education programs, not the long-term effects. Therefore, the specific aims of this study were: (1) to provide long-term follow-up on the effectiveness of a patient and family pain education program on reducing barriers in cancer patients’ use of analgesics and their families’ administration of analgesics and (2) to provide longterm follow-up on the effectiveness of a patient and family pain education program on increasing adherence to a prescribed medication regimen and on decreasing pain intensity and pain interference for cancer patients. 2. Methods 2.1. Participants and settings This study was conducted in the oncology outpatient clinics of two hospitals in the Taipei area. A convenience sample was
recruited for this study consisting of outpatients and their primary family carers. To be included in the study, patients had to: (1) have been diagnosed with cancer, (2) be experiencing cancer pain and currently taking oral analgesics for pain treatment, (3) be over the age of 18 years, and (4) be able to communicate in Mandarin or Taiwanese. For family carers to be included in the study, they had to: (1) be over the age of 18, (2) be identified by the patient as the individual most involved as a carer in their lives, and (3) be able to communicate in Mandarin or Taiwanese. Patient–family pairs were randomly assigned to either the experimental or control group. In total, 61 patients and 61 matched family carers were collected (N = 122). The experimental group consisted of 31 of these patient–family pairs and the control group consisted of 30 of these patient–family pairs. 2.2. Instruments Instruments consisted of the Barriers Questionnaire-Taiwan form (BQT), the Brief Pain Inventory-Chinese version (BPI-C), the Medication Adherence measure, Karnofsky Performance Status (KPS), and a demographic questionnaire. 2.2.1. Barriers Questionnaire-Taiwan form (BQT) The BQT, developed from the Barriers Questionnaire (Ward et al., 1993), was translated for use by Taiwanese and was subsequently modified (Lin, 2000) and now consists of nine subscales (a total of 34 items), including the following: (1) fatalism (i.e., pain medicine cannot really control pain), (2) addiction (i.e., people get addicted to pain medicine easily), (3) desire to be good (i.e., doctors might find it annoying to be told about pain), (4) fear of distracting physicians (i.e., it is more important for the doctor to focus on curing illness than to put time into controlling pain), (5) disease progression (i.e., increased pain is a sign that the illness has gotten worse), (6) tolerance (i.e., pain medicine should be ‘‘saved’’ in case the pain gets worse), (7) side-effects (i.e., pain medicine will cause harm to the liver), (8) religious fatalism (i.e., pain is caused or given by God or Karma and patients have to tolerate the pain in order to avoid carrying the pain into their next life), and (9) p.r.n. or ‘‘as needed’’ (i.e., pain medicine is better given as needed instead of on a scheduled basis). The BQT asks patients to rate the extent to which they agree with each item on a scale from 0 (do not agree at all) to 5 (agree very much). Both subscale scores (the mean of the items in a given subscale) and the total score (the mean of all items) were used in the analyses. The reliability and validity of the BQT has been established (Lin and Ward, 1995; Lin, 2000). 2.2.2. Brief Pain Inventory-Chinese version (BPI-C) The BPI-Chinese version (Wang et al., 1996) was used for this study to measure pain intensity and subsequent interference with life activities. The first part of the BPI consists of the following four, single-item measures of pain intensity with each item rated on a scale of 0 (no pain) to 10 (the worst pain I can imagine): (1) worst pain (please rate your pain by circling the number that best describes your pain at its worst in the last 24 h), (2) least pain (please rate your pain by circling the number that best describes your pain at its least in the last 24 h), (3) average pain (please rate your pain by circling the number that best describes your pain on average), and (4) pain now (please
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rate your pain by circling the number that tells how much pain you have right now). The second part of the BPI consists of the following seven items that assess the extent to which pain interferes with general activities, mood, walking, working, relations with others, sleeping, and enjoyment of life with each item rated on a scale of 0 (does not interfere) to 10 (completely interferes). An interference score (the average of the seven items) was computed. The reliability and validity has been established (Wang et al., 1996; Lin, 2000; Chang et al., 2002). 2.2.3. Self-reporting measure of medication adherence A structured four-item self-reporting measure of medication adherence developed by Morisky et al. (1986) was administered to patients to measure compliance to prescribed use of analgesics for pain. Items in the scale address possible barriers preventing patients from taking medications. The theory underlying this measure is that drug errors of omission can occur for any or all of the following reasons: forgetfulness, carelessness, cessation of the drug when feeling better, and initiation of the drug when feeling worse. The sum of the ‘yes’ answers provides a composite measure of non-adherence. The total score of this measure ranges from 0 to 4 with higher scores indicating higher adherence. The high-adherence group was defined by a total score of 4, the moderate-adherence group by a total score of 2–3, and the low-adherence group by a total score of 0–1. The reliability and concurrent and predictive validities of this measure have been supported (Morisky et al., 1986). The reliability was 0.78 in a Taiwanese cancer pain sample (Chang et al., 2002). 2.2.4. Karnofsky Performance Status (KPS) The Karnofsky Performance Status (KPS) was used to assess patients’ performance status. The KPS is rated on a scale of 1–100, in steps of 10. The KPS has been documented to have good predictive validity (Buccheri et al., 1996). 2.3. Demographic and disease information A demographic information sheet covers basic information on patients and their families, including age, gender, education, marital status, religious beliefs, occupation, and relationships of family carers to patients. A disease information sheet covers a patient’s diagnosis, medications, and treatment status, as well as whether metastasis has or has not occurred. 2.3.1. Pain education intervention The pain education intervention consisted of a Pain Education Booklet and follow-up visits at 2 and 4 weeks after the pain education. A Pain Education Booklet was developed for the current study based on findings from previous studies regarding patient-related barriers to cancer pain management in Taiwan (Lin and Ward, 1995; Lin et al., 2000) and was used for the pain education intervention. With Taiwanese culture in mind, the primary investigator of this current study developed the Pain Education Booklet using concise descriptions and illustrations to provide important information specific to Taiwanese cancer patients’ and their family carers’ concerns about reporting pain and using analgesics. Nine major concerns were covered in this booklet: fatalism, addiction, a desire to be good, fear of distracting physicians, disease progression, tolerance, side-effects, religious fatalism, and p.r.n (use as needed).
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This booklet is pocket-sized, 16 pages long, and was pilot-tested among 20 Taiwanese cancer patients to ensure that the content was readable and understandable. In addition, a panel of experts validated the content of the Pain Education Booklet. Modifications to content were also made based on the comments of patients and experts. This booklet was applied to a pain education program for homecare cancer patients in our pilot study (Chang et al., 2002). 2.3.2. Analgesics use ratio Analgesics use ratio was calculated using the amount of analgesics taken by patients divided by the amount of analgesics prescribed. All medications were standardized using equianalgesics conversion tables to calculate oral morphine equivalents. 2.4. Procedures Approval for this study was obtained from the Human Subject Committee of the hospital. Patient–family pairs that met the selection criteria were randomly assigned to either the experimental or control group using a table of random numbers (Bland, 2000). The research assistant individually approached patients and their family carers to describe the study and obtain informed consent from both patients and their family carers. For the experimental group, on the day of the first interview, the BQT, the BPI-C, and the Self-reporting Measure of Medication Adherence measure were administered to both patients and their family carers, and they were given a demographic questionnaire that they were asked to fill out independently. After patients and family carers had completed the questionnaire, the research assistant provided the pain educational intervention session simultaneously to both patients and family carers. The session was conducted in a private room at the outpatient unit to avoid any interruptions. The research assistant discussed all the content covered in the booklet. Patients and family carers were encouraged to ask any questions regarding the content in the booklet, and the research assistant provided answers. The pain educational intervention took approximately 30–40 min to complete. The booklet contained phone number patients and family carers could call after the educational intervention had been completed to receive answers to any questions they might have concerning the content in the booklet. Patients and family carers were encouraged to call. To reinforce the material in the booklet, a copy of the pain educational booklet was left for the patient and family carer to review. Two and 4 weeks after the pain education intervention, patients returned for scheduled follow-up visits to the outpatient clinic, and at these follow-up visits, the second and third interviews were conducted. Patients and their family carers were asked by a research assistant to complete the BQT, the BPI-C, and the measure of medication adherence again (at these interviews 2 and 4 weeks, respectively, had elapsed since the initial pain education session). Any questions asked by the patient or family carers were answered, and information on pain education was reiterated. Patients and their family carers in the control group received conventional care. No pain educational intervention was given to either patients or family carers. Both patients and family carers in the control group individually and independently completed the BQT, the BPI-C, the measure
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of medication adherence, and a demographic questionnaire at the first interview. Two and 4 weeks after the first interview, both patients and family carers completed the BQT, the BPIC, and the measure of medication adherence again. No educational program was provided for the control group–the research assistant only provided answers if patients or family carers asked any questions. If the interviewer observed that a patient appeared to be in pain or distress or if that patient verbalized pain or distress, the assessment or follow-up was discontinued until the patient could relieve these symptoms. 2.5. Statistical analysis Descriptive statistics were used to describe the demographic and disease characteristics and the BQT, BPI-C, and measure of medication adherence scores. To take into account the repeated measurements’ dependence, a statistical method, called GEE (Generalized Estimating Equations) (Liang and Zeger, 1986; Zeger and Liang, 1986, 1992), was used to analyze whether the pain education program 2 and 4 weeks after administration effectively reduced patients’ and families’ barriers to analgesic use/administration, improved patients’ adherence to a medication schedule, and reduced patients’ pain intensity and pain interference. The baseline heterogeneity (differences existing before the intervention) between the experimental and control groups and the maturation effects (changes in outcome variables resulting from the passage of time) were all controlled by applying the GEE method.
3. Results 3.1. Demographic information on patients and their family carers Demographic characteristics of patients and their family carers in the experimental and control groups are presented in Table 1. The two groups of patients had no significant demographic difference except for the treatment status (i.e., patients who received chemotherapy or radiotherapy vs. those who received neither treatment), which reached significance (p = 0.02). The two groups of family carers showed no demographic differences. 3.2. Descriptive statistics on outcome variables for the experimental and control groups Among both patients and family carers, the four subscales having highest mean scores were addiction, disease progression, tolerance, and p.r.n. (use as needed). Before the intervention, no differences in the BQT total scores existed between the experimental and control group patients and carers. Before the intervention medication adherence differed in that only 6.45% of the experimental group and 0% of the control group reported total compliance with taking analgesics. After the intervention, 29.03% of the experimental group but still none in the control group reported total compliance
with taking analgesics. The analgesics use ratio in the experimental group changed from 0.79 to 0.92 after the intervention; however, the ratio remained about the same (from 0.65 to 0.67) in the control group. For worst pain intensity and pain interference, no differences existed between the experimental and control groups. 3.3. Effects of the pain education program Effects of the pain education program on barriers to analgesic use by patients and their families, patients’ adherence to medication schedules, pain intensity, and pain interference were analyzed by the GEE (Generalized Estimating Equations) method using the ‘‘PROC GENMOD’’ procedure under the SAS/STAT system (version 8.2). There were no statistically significant differences in demographic, disease characteristics, or analgesics use. Treatment status was the only measurement that was statistically different and was, therefore, treated as a confounding variable and added to the analytic models. During the study period, two patients and three carers called the PI and asked questions about the content of the pain education booklet. Most of these questions were related to p.r.n. (use as needed) issue. 3.4. Determining whether the pain education program improved barriers to analgesics use in patients and their family carers Patients in the control group in the second and fourth weeks showed evidence of maturation effects. In other words, the mean BQT scores in the second and fourth weeks were significantly lower than the mean BQT score at the first collection for the control group (p = 0.0495 and 0.0100, respectively). Although at the time of the first collection (baseline), the mean BQT score of the experimental group was significantly lower than that of the control group (p = 0.0396), the reduction slope of the experimental group was significantly larger than that of the control group in the second and fourth weeks (both p values <0.0001), after adjusting for the treatment status effect. Therefore, the pain education program significantly reduced patient barriers to analgesics use (Fig. 1; Table 2). For family carers, a maturation effect was evident in the fourth week as demonstrated by BQT scores that were significantly lower than the mean BQT score initially collected for the control group (p < 0.001). Although at the baseline, the BQT score of the experimental group was significantly lower than that of the control group (p = 0.0153), the reduction slope of the experimental group was significantly larger than that of the control group in the second and fourth weeks (both p values <0.0001) after adjusting for the treatment status effect. Therefore, the pain education program
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Table 1 Demographic and disease characteristics of patients and their family carers of the experimental and control groups (n = 61)
Patients Gender Male Female Marital status Married Not married Metastasis No Yes Treatment status Chemotherapy (C/T) Radiotherapy (R/T) C/T + R/T No C/T or R/T Medication used NSAIDs Codeine Morphine Fentanyl Steroid Antidepressant
Age (years) Education (years) KPS
Family carers Gender Male Female Religion Buddhist Taoist Christian No religion
Age (years) Education (years) a b *
Experimental group (n = 31)
Control group (n = 30)
n
%
n
%
12 19
38.71 61.29
12 18
40 60
24 7
77.4 22.6
26 4
86.7 13.3
7 24
22.6 77.4
9 21
30 70
5 9 1 16
16.1 29.0 3.2 51.6
4 16 3 7
13.3 53.3 10 23.3
22 13 8 7 16 6
71 42 26 23 52 19
19 19 6 9 11 3
63 63 20 30 37 10
Mean
SD
Mean
SD
59.45 7.74 81.29
16.60 4.23 13.84
55.00 8.57 84.67
14.38 4.88 11.37
Experimental group (n = 31)
Control group (n = 30)
n
%
n
%
12 19
38.71 61.29
12 18
40.00 60.00
11 7 4 9
35.48 22.58 12.90 29.03
12 7 4 10
40.00 23.33 13.33 33.33
Mean
SD
Mean
SD
46.19 11.74
12.59 3.71
45.3 9.97
12.48 3.92
v2
p
0.01
0.92
0.88
0.35
0.43
0.51
0.10 3.72 1.14 5.19
0.52 0.05 0.29 0.02* 0.31b 0.20b 0.76b 0.77b 0.30b 0.47b
Za
p a
0.98 0.71a 1.27a v2
0.33 0.48 0.21 p
0.01
0.92
4.36
0.36
Za 0.27a 1.91a
p 0.79 0.06
Mann–Whitney test. Fisher’s exact test. p < 0.05.
significantly reduced family carers’ barriers to analgesics use (Fig. 2; Table 2). 3.5. Determining whether the pain education program improved adherence to scheduled medication use by patients The baseline scores of the experimental and control groups for self-reporting their measure of medication adherence showed no significant difference. The measure
of medication adherence score in the fourth week was significantly higher than at the baseline collection (p = 0.0022), thereby showing a maturation effect for control group patients. However, the reduction slope of the experimental group was significantly larger than that of the control group in the second and fourth weeks (both p values <0.0001), after adjusting for the treatment status effect (Fig. 3; Table 3). Another measure of medication adherence in this study was achieved by comparing the ratio of analgesics
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5
5
4
4
Patient BQT 3 Score
Experimental group Control group
3 Experimental group
2
Family BQT Score
Control group
1
2
1 0 1
2
3
Experimental group
2.19
1.81
1.15
Control group
2.58
2.41
2.32
Test Time
0
Fig. 1. BQT score of patients in the experimental and control groups (test time 1, pretest; 2, second week; 3, fourth week).
use between the experimental group and the control group. At baseline the ratio between the two groups was significantly different; that is, the analgesics use ratio of the experimental group was significantly higher than that of the control group. The control group showed no maturation effect in either the second or fourth weeks. However, the reduction slope of the experimental group was significantly larger than that of the control group in the fourth week (p = 0.0482) after adjusting for the treatment status effect (Fig. 4; Table 3). Therefore, the pain education program had a significant effect on improving the self-reported measure
1
2
3
Experimental group
2.21
1.31
0.99
Control group
2.69
2.55
2.48
Test Time
Fig. 2. BQT score of family carer in the experimental and control groups (test time 1, pretest; 2, second week; 3, fourth week).
of medication adherence and the ratio of analgesics use by patients. 3.6. Determining whether the pain education program reduced the worst pain intensity in patients The worst pain scores between the experimental and control groups at baseline were not significantly different. The worst pain scores for the control group patients in the second and fourth weeks were significantly lower than at baseline (p = 0.01 and 0.0008, respectively),
Table 2 GEE model of the BQT scores for patients and family carers Variable
Regression coefficient
Standard deviation
95% confidence limits
BQT scores of patients Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
2.5823 0.3945 0.1740 0.2600 0.5966 0.7794 0.2096
0.1608 0.1917 0.0872 0.1009 0.1347 0.1670 0.1582
2.2671 0.7702 0.3448 0.4577 0.8606 1.1068 0.5195
BQT scores of family carers Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
2.6949 0.4773 0.1370 0.2051 0.7633 1.0101 0.1025
0.1720 0.1968 0.0717 0.0521 0.1301 0.1299 0.1530
2.3578 0.8630 0.2776 0.3071 1.0182 1.2646 0.4025
Z
p
2.8975 0.0188 0.0032 0.0623 0.3326 0.4520 0.1004
16.06 2.06 2.00 2.58 4.43 4.67 1.32
<0.0001 0.0396* 0.0459* 0.0100* <0.0001* <0.0001* 0.1852
3.0321 0.0915 0.0036 0.1030 0.5084 0.7555 0.1974
15.67 2.42 1.91 3.94 5.87 7.78 0.67
<0.0001 0.0153* 0.0562 <0.0001* <0.0001* <0.0001* 0.5029
Note. Group 1, for experimental group; 0, for control group. Visit 0, for the pretest; 1, for the second week; 2, for the fourth week. Intercept, baseline score in controls. Group 1 vs. Group 0, difference between experimental and control group at baseline. Visit 1 vs. Visit 0, change between visit 0 and visit 1 in controls. Visit 2 vs. Visit 0, change between visit 0 and visit 2 in controls. Interaction of Visit 1 and Group, difference between experimental and control group in change visit 0 visit 1. Interaction of Visit 2 and Group, difference between experimental and control group in change visit 0 visit 2. The change in the experimental group is given by the change in the control group plus the interaction term. * p < 0.05.
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demonstrating a maturation effect. However, the reduction slope of the experimental group was significantly larger than that of the control group in the fourth week (p = 0.0295) after adjusting for the treatment status effect. Therefore, the pain education program was effective in reducing pain interference in patients (Fig. 6; Table 4).
Medication Adherence Score in Experimental Group and Control Group 5 4 Medication Adherence Score
3 Experimental group
2 1 0 1
2
3
Experimental group
0.61
2.23
2.86
Control group
0.88
1.11
1.35
277
Control group
4. Discussion
Test time
Fig. 3. Medication adherence scores in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
thereby demonstrating a maturation effect. However, the reduction slope of the experimental group was significantly larger than that of the control group in the fourth week (p = 0.0386) after adjusting for the treatment status effect. This result shows that the pain education program effectively lowered the worst pain intensity in patients (Fig. 5; Table 4). 3.7. Determining whether the pain education program reduced pain interference in patients The pain interference scores between the experimental and control groups at the baseline collection were not significantly different. The pain interference scores for the control group patients in the fourth week were significantly lower than at baseline (p < 0.0001), thereby
Patients and family carers’ concerns about the use of analgesics have been identified as barriers to management of cancer pain in Taiwan (Lin and Ward, 1995; Lin, 2000; Lin et al., 2000). Educational programs have been documented as being effective in reducing barriers and increasing the compliance of cancer pain patients (Jones et al., 1984; Rimer et al., 1987; Ferrell et al., 1994) and of non-cancer pain patients (Lorig et al., 1987; Mullen et al., 1987; Lorig and Holman, 1989; Lorig et al., 1989; Lindorth et al., 1995). To date, however, educational programs about pain management have been directed primarily at patients. Limited efforts have been directed toward developing a pain education program for both family carers and patients and in evaluating its long-term effectiveness in overcoming patient and carer barriers and improving pain treatment. Involvement of both patients and their family carers in pain educational programs is important given the fact that patient and carer concerns are significantly correlated and ultimately related to the adequacy of patient pain treatment (Lin, 2000). In the second and fourth weeks after the intervention, barrier scores of both patients
Table 3 GEE model of medication adherence and analgesics use by patients Variable
Regression coefficient
Standard deviation
95% confidence limits
Z
p
Medication adherence Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
0.8751 2.0681 0.2333 0.4706 1.3917 1.7794 0.1195
0.2878 0.3034 0.1807 0.1538 0.3529 0.3325 0.2555
0.3110 0.8629 0.1209 0.1692 0.6999 1.1277 0.3814
1.4392 0.3266 0.5875 0.7721 2.0834 2.4310 0.6203
3.04 0.88 1.29 3.06 3.94 5.35 0.47
0.0024 0.3769 0.1967 0.0022* <0.0001* <0.0001* 0.6402
Analgesic use Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
0.6651 0.1293 0.0177 0.0245 0.0753 0.1475 0.0092
0.0598 0.0622 0.0457 0.0614 0.0554 0.0746 0.0412
0.5479 0.0074 0.0718 0.1448 0.0333 0.0012 0.0715
0.7823 0.2512 0.1072 0.0958 0.1839 0.2937 0.0900
11.12 2.08 0.39 0.40 1.36 1.98 0.22
<0.001 0.0376 0.6980 0.6894 0.1742 0.0482* 0.8225
Note. Group 1, for the experimental group; 0, for the control group. Visit 0, for the pretest; 1 for the second week; 2 for the fourth week. Intercept, baseline score in controls. Group 1 vs. Group 0, difference between experimental and control group at baseline. Visit 1 vs. Visit 0, change between visit 0 and visit 1 in controls. Visit 2 vs. Visit 0, change between visit 0 and visit 2 in controls. Interaction of Visit 1 and Group, difference between experimental and control group in change visit 0 visit 1. Interaction of Visit 2 and Group, difference between experimental and control group in change visit 0 visit 2. The change in the experimental group is given by the change in the control group plus the interaction term. * p < 0.05.
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Ratio of Analgesics Use in Experimental Group and Control Group
1 0.8 Ratio of Analgesics Use
0.6 Experimental group
0.4 0.2
Control group
0 1
2
3
Experimental group
0.8
0.9
0.93
Control group
0.67
0.69
0.64
Test time
Fig. 4. Ratio of analgesics use in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
and family carers in the experimental group were significantly lower than those of the control group after controlling for pre-intervention differences and maturation effects. These barrier scores demonstrate that, whether short-term or long-term, barriers to scheduled analgesics use in the experimental group were lower than in the control group. Despite the fact that the control group received no patient and family education program, this group demonstrated a maturation effect in barrier scores, regardless of it being in the second or fourth week after the initial data collection. This maturation effect might be due to the fact that because of ethical considerations, any questions related to analgesic use were answered in detail despite the fact that this group had not participated in the pain education intervention. In contrast, both patients and their families in the experimental group were simultaneously provided a pain education program and any misconceptions about analgesics use were constantly clarified through the education program. Patients and family members’ concerns about analgesics use are closely interrelated (Lin, 2000). When a
Worst Pain in Experimental Group and Control Group
Worst Pain Intensity
7 6 5 4 3 2
Experimental group control group
1
2
3
Experimental group
6.02
4.6
3.19
control group
6.19
5.6
4.69
Test time
Fig. 5. Worst pain in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
family member has correct knowledge about analgesics, that individual becomes a more accurate spokesperson and better carer for homecare cancer patients and can help healthcare workers monitor and evaluate the effectiveness of pain management. Therefore, including family members in pain education program is beneficial to the effectiveness of pain education interventions. Failure of pain management is often due to reluctance to administer analgesics according to the dose and time interval prescribed by physicians because of patient or family carer concerns about analgesic use (Ward et al., 1993; AHCPR, 1994; Lin, 2000; Lin et al., 2000; Gunnarsdottir et al., 2002). If patients do not take analgesics according to the prescribed schedule and dosage, pain management becomes ambiguous because drug efficacy or dosage becomes difficult to evaluate and the amount of drug titration for pain management becomes even more difficult to determine. In the present study, medication adherence scores of the two groups at the pretest showed that patients’ adherence to a prescribed medication schedule was generally inadequate. About 75% of the experimental group and 70% of the control group belonged to the low-adherence group (0–1). Therefore, medication adherence in Taiwanese patients needs further improvement. In this study, the patient and family pain education program effectively improved medication adherence and the analgesic use ratio after controlling for pre-intervention differences and maturation effects, and these results are consistent with outcomes of other studies. Rimer et al. (1987) found that patients who received pain education had better adherence to medication schedules than did patients who did not receive education. In addition, patients who received pain education did not self-terminate their medication when the pain lessened. Ferrell et al. (1993) presented a systemic pain education program to 40 pairs of elderly cancer patients and their families and found a significant increase in medication adherence, an increase in knowledge of analgesics, and an increase in scheduled use of medication as opposed to an as needed approach. In this study, the patient and family pain education program also effectively reduced levels of worst pain in patients in the fourth week after the intervention when controlling for pre-intervention differences and maturation effects. Levels of worst pain in patients also decreased in the control group as time progressed, (i.e., maturation effect) but there was a statistically significant difference in levels of worst pain between the two groups in the fourth week, with the experimental group showing a greater decrease in worst pain. Worst pain levels may have decreased in the control group because patient and family carer questions about analgesics use were answered even though no education program was provided, resulting in a decrease of barriers to analgesics use and an increase in adherence to a pre-
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279
Table 4 GEE model of worst pain intensity and pain interference in patients Variable
Regression coefficient
Standard deviation
95% confidence limits
Z
p
Worst pain intensity Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
6.1907 0.1657 1.0333 1.5039 0.3860 1.3348 0.1183
0.5083 0.5640 0.4011 0.4474 0.6025 0.6453 0.4048
5.1945 1.2712 1.8194 2.3808 1.5669 2.5996 0.9116
7.1869 0.9398 0.2473 0.6271 0.7949 0.0700 0.6751
12.18 0.29 2.58 3.36 0.64 2.07 0.29
<0.0001* 0.7689 0.0100* 0.0008* 0.5217 0.0386* 0.7701
Pain interference Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
4.3733 0.0358 0.6930 1.5146 0.9660 1.2373 0.2317
0.6116 0.6959 0.4154 0.3607 0.5478 0.5685 0.4982
3.1746 1.3281 1.5072 2.2215 2.0398 2.3516 0.7447
5.5720 1.3997 0.1212 0.8077 0.1077 0.1230 1.2081
7.15 0.05 1.67 4.20 1.76 2.18 0.47
<0.0001 0.9589 0.0953 <0.0001* 0.0778 0.0295* 0.6418
Note. Group 1, for the experimental group; 0, for the control group. Visit 0, for the pretest; 1, for the second week; 2, for the fourth week. Intercept, baseline score in controls. Group 1 vs. Group 0, difference between experimental and control group at baseline. Visit 1 vs. Visit 0, change between visit 0 and visit 1 in controls. Visit 2 vs. Visit 0, change between visit 0 and visit 2 in controls. Interaction of Visit 1 and Group, difference between experimental and control group in change visit 0 visit 1. Interaction of Visit 2 and Group, difference between experimental and control group in change visit 0 visit 2. The change in the experimental group is given by the change in the control group plus the interaction term. * p < 0.05.
scribed medication regimen. Worst pain has often been used clinically as an indicator of treatment and is the most highly correlated to pain interference (Serlin et al., 1995). In a study that investigated the influence of pain severity on patients’ quality of life, it was found that worst pain could be used as a major indicator for evaluating the quality of life (Wang et al., 1999). Consequently, by improving the worst pain of patients, pain interference and quality of life can also possibly be improved. A past study on the effects of pain education of patients failed to show a significant reduction in worst pain levels (Chang et al., 2002). Ferrell et al. (1993) found that a pain education program could reduce the overall average pain intensity. Pain Interference in Experimental Group and Control Group 5 4 Average Pain Interference
3
Experimental group
2
Control group
1 0 1
2
3
Experimental group
4.33
2.67
1.58
Control group
4.37
3.68
2.86
Test time
Fig. 6. Pain interference in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
The patient and family pain education program significantly reduced levels of pain interference in the fourth week after the intervention in this study even though a maturation effect was also apparent in the control group. Some large-scale, long-term studies discovered that pain education programs do not display significant results in improving pain interference with general activities or patients’ sleep or mood (de Wit et al., 1997; Wells et al., 2003). The present research showed significant difference in reduction slopes of pain interference between the two groups only in the fourth week, confirming that improved pain interference might not be achieved in a short time period. The improvement of pain interference or pain intensity in the control group (i.e., maturation effect) may be due to the appropriate use of analgesics and rapid titration. To date, most studies on pain education have primarily focused only on patients, or provided only a single pain education session (Ferrell et al., 1994; Oliver et al., 2001; Chang et al., 2002) rather than an on-going evaluation. Oliver et al. (2001) discovered that a pain education program can reduce pain frequency in patients, but another study (Chang et al., 2002) found that regardless of whether or not patients participated in a pain education program, there were no significant findings on pain intensity or pain interference after 2 weeks of intervention. A larger study found a significant difference in average pain and present pain but no significant difference in worst pain (de Wit et al., 1997). A large-scale, long-term study that offered pain education to both patients and their families by telephone and telephone interviews showed, after 6 months of
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intervention, no difference in pain intensity of patients (Wells et al., 2003). These results may suggest that the telephone is not as effective as face-to-face interviews nor multiple health education programs in pain education. The success achieved by this study in pain education for Taiwanese patients and family carers may be due to ongoing reinforcement and evaluation, faceto-face interviews, and most importantly, simultaneous involvement of patients and their family carers. The beneficial effect of this pain education on pain scores for those participants in the experimental group could be due to a placebo effect; however, such impact has not been commonly observed in other pain education studies (de Wit et al., 1997; Chang et al., 2002; Wells et al., 2003). The length of time the pain education achieved in this study will remain effective is not known because the long-term effects of pain education interventions have not been well documented (de Wit et al., 1997; Wells et al., 2003). We hypothesize that the beneficial effects of pain education demonstrated by this study may be sustained over a longer period of time if face-to-face reinforcement for both patients and family carers is periodically continued. In conclusion, this study is the first to examine the effect of a patient and family pain education intervention program in Taiwan and to analyze the results using the Generalized Estimating Equations (GEE). Results of this study demonstrate that an on-going, face-to-face pain education program with explanatory answers to analgesic-related questions provided simultaneously to patients and their family carers reduces barriers pain management, increases adherence to scheduled analgesic use, and decreases the worst pain score and the level of pain interference. This type of educational program if incorporated into future clinical practice could have great potential to improve the quality of pain management for cancer patients.
Acknowledgments This study was funded by the NSC 89-2314-B-083069 from the National Science Council in Taiwan. The authors thank Ms. Denise Dipert for her careful review and editing this manuscript.
References Agency for Health Care Policy and Research, 1994. Management of care pain. AHCPR Publ. No. 94-0592, Rockville, MD: AHCPR, US Department of Health and Human Services. Bland M. An introduction to medical statistics. Oxford: Oxford University Press; 2000. Buccheri G, Ferrigno D, Tamburini M. Karnofsky and ECOG performance status scoring in lung cancer: a prospective, longitudinal study of 536 patients from a single institution. Eur J Cancer 1996;32:1135–41.
Chang MC, Chang YC, Chiour JF, Tsou TS, Lin CC. Overcoming patient-related barriers to a cancer pain management for home care patients. Cancer Nurs 2002;25:470–6. Chelf JH, Agre P, Alxelrod A, Cheney L, Cole DD, Conrad K, et al. Cancer-related patient education: an overview of the last decade of evaluation and research. Oncol Nurs Forum 2001;28:1139–47. de Wit R, van Dam F, Zandbelt L, van Buura A, van der Heijden K, Leenhouts G, et al. A pain education program for chronic cancer pain patients: follow up results a randomized controlled trial. Pain 1997;73:55–69. Ferrell BR, Ferrell BA, Ahn C, Tran K. Pain management for elderly patients with cancer at home. Cancer 1994;74(Suppl.):2139–46. Ferrell BR, Grant M, Chan J, Ahn C, Ferrell BA. The impact of cancer pain education on family caregivers of elderly patients. Oncol Nurs Forum 1995;22:1211–8. Ferrell BR, Rhiner M, Ferrell BA. Development and implementation of pain educational program. Cancer 1993;72(Suppl.):3426–35. Ferrell BR, Rivaera L. Cancer pain education for patients. Semin Oncol Nurs 1997;13:42–8. Gunnarsdottir S, Donovan HS, Serlin RC, Voge C, Ward S. Patientrelated barriers to pain management: the barriers questionnaire II (BQ-II). Pain 2002;99:385–96. Jones W, Rimer B, Levy M, Kinman J. Cancer patients’ knowledge, beliefs, and behavior regarding pain control regimens: implications for education programs. Patient Educ Couns 1984;5:159–64. Liang KY, Zeger SL. Longitudinal data analysis using generalized liner models. Biometrika 1986;73:13–22. Lin CC. Barriers to the analgesic management of cancer pain: a comparison of attitudes of Taiwan patients and their family caregivers. Pain 2000;88:1–7. Lin CC, Wang P, Lai Y, Lin C, Tsai S, Chen TT. Identifying attitudinal barriers to family management of cancer pain in palliative care in Taiwan. Palliat Med 2000;14:463–70. Lin CC, Ward SE. Patient-related barriers to cancer pain management in Taiwan. Cancer Nurs 1995;18:16–22. Lindorth Y, Bauman A, Brooks PM, Priestley D. A 5-year follow-up of a controlled trial of an arthritis education programme. Br J Rheumatol 1995;34:647–52. Lorig K, Holman HR. Long-term outcomes of an arthritis selfmanagement study: effects of reinforcement efforts. Soc Sci Med 1989;29:221–4. Lorig K, Konkol L, Gonzales V. Arthritis patient education: a review of the literature. Patient Educ Couns 1987;10:207–52. Lorig K, Manzonson PD, Holman HR. Four-year clinical and service utilization benefits of arthritis patient education. Arthritis Rheum 1989;32:S99. Miaskowski C, Zimmer E, Barrett K, Dibble S, Wallhagen M. Difference in patients’ and family caregivers’ perceptions of the pain experience influence patient and caregiver outcomes. Pain 1997;72:217–26. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986;24:67–74. Mullen PD, Laville EA, Biddle AK, Lorig K. Efficacy of psychoeducational interventions in pain, depression and disability in people with arthritis: a meta-analysis. J Rheumatol 1987;14: 33–9. Oliver JW, Kravitz RL, Kaplan SH. Individualized patient education and coaching to improve pain control among cancer outpatients. J Clin Oncol 2001;19:2206–12. Redinbaugh EM, Baum A, DeMoss C, Fello M, Arnold R. Factors associated with the accuracy of family caregiver estimates of patient pain. J Pain Symptom Manage 2002;23:31–8. Rimer B, Levy MH, Keinta MK, Fox L, Engstrom PE, MacElwee N. Enhancing cancer pain control regimens through patient education. Patient Educ Couns 1987;10:267–77.
C.-C. Lin et al. / Pain 122 (2006) 271–281 Serlin RC, Mendoza TR, Nakamura Y, Edwards KR, Cleeland CS. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 1995;61: 277–84. Wang XS, Cleeland CS, Mendoza TR, Engstrom MC, Liu S, Xu G, et al. The effects of pain severity on health-related quality of life. Cancer 1999;86:1848–55. Wang XS, Mendoza TR, Gao SZ, Cleeland CS. The Chinese version of the Brief Pain Inventory (BPI-C): its development and use in a study of cancer pain. Pain 1996;67:407–16.
281
Ward SE, Goldberg N, McCauley VM, Mueller C, Nolan A, Plank DP, et al. Patient-related barriers to management of cancer pain. Pain 1993;52:319–24. Wells N, Hepworth JT, Murphy BA, Wujcik D, Johnson R. Improving cancer pain management through patient and family education. J Pain Symptom Manage 2003;25:344–56. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics 1986;42:121–30. Zeger SL, Liang KY. An overview of methods for the analysis of longitudinal data. Stat Med 1992;11:1825–30.
Long-term effectiveness of a patient and family pain education program on overcoming barriers to management of cancer pain Chia-Chin Lin
a,*
, Pi-Ling Chou b, Shang-Liang Wu c, Yue-Cune Chang d, Yuen-Liang Lai e,f,g
a
Graduate Institute of Nursing, Taipei Medical University, Taipei, Taiwan b Shu-Zen College of Medicine and Management, Kaohsiung, Taiwan c Bureau of Health Promotion, Department of Health, Taiwan d Department of Mathematics, Tamkang University, Taiwan e Hospice and Pallative Care Center, Mackay Memorial Hospital, Taiwan f Center of General Education, National Yang-Ming University, Taiwan g School of Medicine, Taipei Medical University, Taiwan
Received 3 December 2004; received in revised form 22 December 2005; accepted 26 January 2006
Abstract The purpose of this research was to investigate the effectiveness of a patient and family pain education program on reducing cancer patients’ and their families’ barriers to (i.e., concerns or misconceptions about) cancer pain management, on increasing patients’ adherence to a prescribed analgesic regimen, and on decreasing pain intensity and pain interference with daily life. An experimental and longitudinal design was used. The experimental group consisted of 31 pairs of cancer outpatients and their family carers, while the control group consisted of 30 patient–family pairs (N = 122). Patients and their family carers in the experimental group simultaneously received a pain management education program. Both groups had pretest data collection and after-test follow-ups on the second and fourth weeks at the outpatient clinics. Comparisons between those two groups were made using the Generalized Estimating Equations (GEE) method. Results revealed that at both the second and fourth weeks, patients and family carers in the experimental group showed a significantly greater reduction in barrier scores than did patients and family carers in the control group. At the second and fourth weeks, patients in the experimental group reported significantly better adherence to a scheduled analgesic regimen than did patients in the control group. In the fourth week, patients in the experimental group reported significantly lower levels of worst pain intensity and pain interference than did patients in the control group. This research provides evidence of the effectiveness of a patient and family pain education program. Ó 2006 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. Keywords: Cancer pain; Pain management; Pain education program; Barriers to pain management; Family
1. Introduction The hesitancy among Taiwanese cancer patients and their family carers to report pain and to use analgesics *
Corresponding author. Tel.: +886 2 23776229; fax: +886 2 23772842. E-mail address: [email protected] (C.-C. Lin).
is a barrier to optimal cancer pain management (Lin and Ward, 1995; Lin, 2000; Lin et al., 2000). If family carers misunderstand the effects of analgesics, they may be hesitant to administer these drugs and pain reports will not be accurate (Lin and Ward, 1995; Lin, 2000). Most studies have focused only on patient education and few have supported the effectiveness of pain education programs in reducing misconceptions about analgesics,
0304-3959/$32.00 Ó 2006 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.pain.2006.01.039
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increasing knowledge about pain, or increasing compliance in the administration of pain medication (Rimer et al., 1987; Ferrell et al., 1994; de Wit et al., 1997). No study has involved both patients and family carers in Taiwan. Therefore, the purposes of this study were to investigate the long-term effectiveness of a simultaneous Taiwanese patient and family pain education program. A recent study using the Barriers Questionnaire-Taiwan form identified nine common concerns of Taiwanese cancer patients and their family carers about reporting pain and using analgesics (Lin, 2000). These concerns included the belief that medicine cannot really control pain, the fear of addiction, a desire to be a ‘‘good patient’’ by not complaining about pain, the fear that one’s physician will be distracted from treating the disease to controlling the pain, the concern that increasing pain signifies disease progression, the belief that medication should be saved in case the pain gets worse, the concern about side-effects of analgesics, the belief that the pain is caused by God or Karma and must be endured, and the concern that pain medications are better given as needed instead of on an around-the-clock scheduled basis. These concerns were held by almost all patients and family carers and contributed to their reluctance to report pain and to use analgesics, which, in turn, contributed to inadequate pain control (Lin, 2000). Past studies have provided some evidence about the effectiveness of pain education programs (Rimer et al., 1987; Ferrell et al., 1993, 1994, 1995; de Wit et al., 1997; Ferrell and Rivaera, 1997; Chelf et al., 2001; Oliver et al., 2001). The importance of evaluating patients’ and their family members’ experience with pain expression and of establishing the role their attitudes play in the correct administration of analgesics in pain management has been studied (Miaskowski et al., 1997; Lin, 2000; Redinbaugh et al., 2002). However, the contribution of family carers to pain education and management of cancer pain has not been well documented. In addition, most researchers have investigated the short-term effects of pain management education programs, not the long-term effects. Therefore, the specific aims of this study were: (1) to provide long-term follow-up on the effectiveness of a patient and family pain education program on reducing barriers in cancer patients’ use of analgesics and their families’ administration of analgesics and (2) to provide longterm follow-up on the effectiveness of a patient and family pain education program on increasing adherence to a prescribed medication regimen and on decreasing pain intensity and pain interference for cancer patients. 2. Methods 2.1. Participants and settings This study was conducted in the oncology outpatient clinics of two hospitals in the Taipei area. A convenience sample was
recruited for this study consisting of outpatients and their primary family carers. To be included in the study, patients had to: (1) have been diagnosed with cancer, (2) be experiencing cancer pain and currently taking oral analgesics for pain treatment, (3) be over the age of 18 years, and (4) be able to communicate in Mandarin or Taiwanese. For family carers to be included in the study, they had to: (1) be over the age of 18, (2) be identified by the patient as the individual most involved as a carer in their lives, and (3) be able to communicate in Mandarin or Taiwanese. Patient–family pairs were randomly assigned to either the experimental or control group. In total, 61 patients and 61 matched family carers were collected (N = 122). The experimental group consisted of 31 of these patient–family pairs and the control group consisted of 30 of these patient–family pairs. 2.2. Instruments Instruments consisted of the Barriers Questionnaire-Taiwan form (BQT), the Brief Pain Inventory-Chinese version (BPI-C), the Medication Adherence measure, Karnofsky Performance Status (KPS), and a demographic questionnaire. 2.2.1. Barriers Questionnaire-Taiwan form (BQT) The BQT, developed from the Barriers Questionnaire (Ward et al., 1993), was translated for use by Taiwanese and was subsequently modified (Lin, 2000) and now consists of nine subscales (a total of 34 items), including the following: (1) fatalism (i.e., pain medicine cannot really control pain), (2) addiction (i.e., people get addicted to pain medicine easily), (3) desire to be good (i.e., doctors might find it annoying to be told about pain), (4) fear of distracting physicians (i.e., it is more important for the doctor to focus on curing illness than to put time into controlling pain), (5) disease progression (i.e., increased pain is a sign that the illness has gotten worse), (6) tolerance (i.e., pain medicine should be ‘‘saved’’ in case the pain gets worse), (7) side-effects (i.e., pain medicine will cause harm to the liver), (8) religious fatalism (i.e., pain is caused or given by God or Karma and patients have to tolerate the pain in order to avoid carrying the pain into their next life), and (9) p.r.n. or ‘‘as needed’’ (i.e., pain medicine is better given as needed instead of on a scheduled basis). The BQT asks patients to rate the extent to which they agree with each item on a scale from 0 (do not agree at all) to 5 (agree very much). Both subscale scores (the mean of the items in a given subscale) and the total score (the mean of all items) were used in the analyses. The reliability and validity of the BQT has been established (Lin and Ward, 1995; Lin, 2000). 2.2.2. Brief Pain Inventory-Chinese version (BPI-C) The BPI-Chinese version (Wang et al., 1996) was used for this study to measure pain intensity and subsequent interference with life activities. The first part of the BPI consists of the following four, single-item measures of pain intensity with each item rated on a scale of 0 (no pain) to 10 (the worst pain I can imagine): (1) worst pain (please rate your pain by circling the number that best describes your pain at its worst in the last 24 h), (2) least pain (please rate your pain by circling the number that best describes your pain at its least in the last 24 h), (3) average pain (please rate your pain by circling the number that best describes your pain on average), and (4) pain now (please
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rate your pain by circling the number that tells how much pain you have right now). The second part of the BPI consists of the following seven items that assess the extent to which pain interferes with general activities, mood, walking, working, relations with others, sleeping, and enjoyment of life with each item rated on a scale of 0 (does not interfere) to 10 (completely interferes). An interference score (the average of the seven items) was computed. The reliability and validity has been established (Wang et al., 1996; Lin, 2000; Chang et al., 2002). 2.2.3. Self-reporting measure of medication adherence A structured four-item self-reporting measure of medication adherence developed by Morisky et al. (1986) was administered to patients to measure compliance to prescribed use of analgesics for pain. Items in the scale address possible barriers preventing patients from taking medications. The theory underlying this measure is that drug errors of omission can occur for any or all of the following reasons: forgetfulness, carelessness, cessation of the drug when feeling better, and initiation of the drug when feeling worse. The sum of the ‘yes’ answers provides a composite measure of non-adherence. The total score of this measure ranges from 0 to 4 with higher scores indicating higher adherence. The high-adherence group was defined by a total score of 4, the moderate-adherence group by a total score of 2–3, and the low-adherence group by a total score of 0–1. The reliability and concurrent and predictive validities of this measure have been supported (Morisky et al., 1986). The reliability was 0.78 in a Taiwanese cancer pain sample (Chang et al., 2002). 2.2.4. Karnofsky Performance Status (KPS) The Karnofsky Performance Status (KPS) was used to assess patients’ performance status. The KPS is rated on a scale of 1–100, in steps of 10. The KPS has been documented to have good predictive validity (Buccheri et al., 1996). 2.3. Demographic and disease information A demographic information sheet covers basic information on patients and their families, including age, gender, education, marital status, religious beliefs, occupation, and relationships of family carers to patients. A disease information sheet covers a patient’s diagnosis, medications, and treatment status, as well as whether metastasis has or has not occurred. 2.3.1. Pain education intervention The pain education intervention consisted of a Pain Education Booklet and follow-up visits at 2 and 4 weeks after the pain education. A Pain Education Booklet was developed for the current study based on findings from previous studies regarding patient-related barriers to cancer pain management in Taiwan (Lin and Ward, 1995; Lin et al., 2000) and was used for the pain education intervention. With Taiwanese culture in mind, the primary investigator of this current study developed the Pain Education Booklet using concise descriptions and illustrations to provide important information specific to Taiwanese cancer patients’ and their family carers’ concerns about reporting pain and using analgesics. Nine major concerns were covered in this booklet: fatalism, addiction, a desire to be good, fear of distracting physicians, disease progression, tolerance, side-effects, religious fatalism, and p.r.n (use as needed).
273
This booklet is pocket-sized, 16 pages long, and was pilot-tested among 20 Taiwanese cancer patients to ensure that the content was readable and understandable. In addition, a panel of experts validated the content of the Pain Education Booklet. Modifications to content were also made based on the comments of patients and experts. This booklet was applied to a pain education program for homecare cancer patients in our pilot study (Chang et al., 2002). 2.3.2. Analgesics use ratio Analgesics use ratio was calculated using the amount of analgesics taken by patients divided by the amount of analgesics prescribed. All medications were standardized using equianalgesics conversion tables to calculate oral morphine equivalents. 2.4. Procedures Approval for this study was obtained from the Human Subject Committee of the hospital. Patient–family pairs that met the selection criteria were randomly assigned to either the experimental or control group using a table of random numbers (Bland, 2000). The research assistant individually approached patients and their family carers to describe the study and obtain informed consent from both patients and their family carers. For the experimental group, on the day of the first interview, the BQT, the BPI-C, and the Self-reporting Measure of Medication Adherence measure were administered to both patients and their family carers, and they were given a demographic questionnaire that they were asked to fill out independently. After patients and family carers had completed the questionnaire, the research assistant provided the pain educational intervention session simultaneously to both patients and family carers. The session was conducted in a private room at the outpatient unit to avoid any interruptions. The research assistant discussed all the content covered in the booklet. Patients and family carers were encouraged to ask any questions regarding the content in the booklet, and the research assistant provided answers. The pain educational intervention took approximately 30–40 min to complete. The booklet contained phone number patients and family carers could call after the educational intervention had been completed to receive answers to any questions they might have concerning the content in the booklet. Patients and family carers were encouraged to call. To reinforce the material in the booklet, a copy of the pain educational booklet was left for the patient and family carer to review. Two and 4 weeks after the pain education intervention, patients returned for scheduled follow-up visits to the outpatient clinic, and at these follow-up visits, the second and third interviews were conducted. Patients and their family carers were asked by a research assistant to complete the BQT, the BPI-C, and the measure of medication adherence again (at these interviews 2 and 4 weeks, respectively, had elapsed since the initial pain education session). Any questions asked by the patient or family carers were answered, and information on pain education was reiterated. Patients and their family carers in the control group received conventional care. No pain educational intervention was given to either patients or family carers. Both patients and family carers in the control group individually and independently completed the BQT, the BPI-C, the measure
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of medication adherence, and a demographic questionnaire at the first interview. Two and 4 weeks after the first interview, both patients and family carers completed the BQT, the BPIC, and the measure of medication adherence again. No educational program was provided for the control group–the research assistant only provided answers if patients or family carers asked any questions. If the interviewer observed that a patient appeared to be in pain or distress or if that patient verbalized pain or distress, the assessment or follow-up was discontinued until the patient could relieve these symptoms. 2.5. Statistical analysis Descriptive statistics were used to describe the demographic and disease characteristics and the BQT, BPI-C, and measure of medication adherence scores. To take into account the repeated measurements’ dependence, a statistical method, called GEE (Generalized Estimating Equations) (Liang and Zeger, 1986; Zeger and Liang, 1986, 1992), was used to analyze whether the pain education program 2 and 4 weeks after administration effectively reduced patients’ and families’ barriers to analgesic use/administration, improved patients’ adherence to a medication schedule, and reduced patients’ pain intensity and pain interference. The baseline heterogeneity (differences existing before the intervention) between the experimental and control groups and the maturation effects (changes in outcome variables resulting from the passage of time) were all controlled by applying the GEE method.
3. Results 3.1. Demographic information on patients and their family carers Demographic characteristics of patients and their family carers in the experimental and control groups are presented in Table 1. The two groups of patients had no significant demographic difference except for the treatment status (i.e., patients who received chemotherapy or radiotherapy vs. those who received neither treatment), which reached significance (p = 0.02). The two groups of family carers showed no demographic differences. 3.2. Descriptive statistics on outcome variables for the experimental and control groups Among both patients and family carers, the four subscales having highest mean scores were addiction, disease progression, tolerance, and p.r.n. (use as needed). Before the intervention, no differences in the BQT total scores existed between the experimental and control group patients and carers. Before the intervention medication adherence differed in that only 6.45% of the experimental group and 0% of the control group reported total compliance with taking analgesics. After the intervention, 29.03% of the experimental group but still none in the control group reported total compliance
with taking analgesics. The analgesics use ratio in the experimental group changed from 0.79 to 0.92 after the intervention; however, the ratio remained about the same (from 0.65 to 0.67) in the control group. For worst pain intensity and pain interference, no differences existed between the experimental and control groups. 3.3. Effects of the pain education program Effects of the pain education program on barriers to analgesic use by patients and their families, patients’ adherence to medication schedules, pain intensity, and pain interference were analyzed by the GEE (Generalized Estimating Equations) method using the ‘‘PROC GENMOD’’ procedure under the SAS/STAT system (version 8.2). There were no statistically significant differences in demographic, disease characteristics, or analgesics use. Treatment status was the only measurement that was statistically different and was, therefore, treated as a confounding variable and added to the analytic models. During the study period, two patients and three carers called the PI and asked questions about the content of the pain education booklet. Most of these questions were related to p.r.n. (use as needed) issue. 3.4. Determining whether the pain education program improved barriers to analgesics use in patients and their family carers Patients in the control group in the second and fourth weeks showed evidence of maturation effects. In other words, the mean BQT scores in the second and fourth weeks were significantly lower than the mean BQT score at the first collection for the control group (p = 0.0495 and 0.0100, respectively). Although at the time of the first collection (baseline), the mean BQT score of the experimental group was significantly lower than that of the control group (p = 0.0396), the reduction slope of the experimental group was significantly larger than that of the control group in the second and fourth weeks (both p values <0.0001), after adjusting for the treatment status effect. Therefore, the pain education program significantly reduced patient barriers to analgesics use (Fig. 1; Table 2). For family carers, a maturation effect was evident in the fourth week as demonstrated by BQT scores that were significantly lower than the mean BQT score initially collected for the control group (p < 0.001). Although at the baseline, the BQT score of the experimental group was significantly lower than that of the control group (p = 0.0153), the reduction slope of the experimental group was significantly larger than that of the control group in the second and fourth weeks (both p values <0.0001) after adjusting for the treatment status effect. Therefore, the pain education program
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Table 1 Demographic and disease characteristics of patients and their family carers of the experimental and control groups (n = 61)
Patients Gender Male Female Marital status Married Not married Metastasis No Yes Treatment status Chemotherapy (C/T) Radiotherapy (R/T) C/T + R/T No C/T or R/T Medication used NSAIDs Codeine Morphine Fentanyl Steroid Antidepressant
Age (years) Education (years) KPS
Family carers Gender Male Female Religion Buddhist Taoist Christian No religion
Age (years) Education (years) a b *
Experimental group (n = 31)
Control group (n = 30)
n
%
n
%
12 19
38.71 61.29
12 18
40 60
24 7
77.4 22.6
26 4
86.7 13.3
7 24
22.6 77.4
9 21
30 70
5 9 1 16
16.1 29.0 3.2 51.6
4 16 3 7
13.3 53.3 10 23.3
22 13 8 7 16 6
71 42 26 23 52 19
19 19 6 9 11 3
63 63 20 30 37 10
Mean
SD
Mean
SD
59.45 7.74 81.29
16.60 4.23 13.84
55.00 8.57 84.67
14.38 4.88 11.37
Experimental group (n = 31)
Control group (n = 30)
n
%
n
%
12 19
38.71 61.29
12 18
40.00 60.00
11 7 4 9
35.48 22.58 12.90 29.03
12 7 4 10
40.00 23.33 13.33 33.33
Mean
SD
Mean
SD
46.19 11.74
12.59 3.71
45.3 9.97
12.48 3.92
v2
p
0.01
0.92
0.88
0.35
0.43
0.51
0.10 3.72 1.14 5.19
0.52 0.05 0.29 0.02* 0.31b 0.20b 0.76b 0.77b 0.30b 0.47b
Za
p a
0.98 0.71a 1.27a v2
0.33 0.48 0.21 p
0.01
0.92
4.36
0.36
Za 0.27a 1.91a
p 0.79 0.06
Mann–Whitney test. Fisher’s exact test. p < 0.05.
significantly reduced family carers’ barriers to analgesics use (Fig. 2; Table 2). 3.5. Determining whether the pain education program improved adherence to scheduled medication use by patients The baseline scores of the experimental and control groups for self-reporting their measure of medication adherence showed no significant difference. The measure
of medication adherence score in the fourth week was significantly higher than at the baseline collection (p = 0.0022), thereby showing a maturation effect for control group patients. However, the reduction slope of the experimental group was significantly larger than that of the control group in the second and fourth weeks (both p values <0.0001), after adjusting for the treatment status effect (Fig. 3; Table 3). Another measure of medication adherence in this study was achieved by comparing the ratio of analgesics
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5
5
4
4
Patient BQT 3 Score
Experimental group Control group
3 Experimental group
2
Family BQT Score
Control group
1
2
1 0 1
2
3
Experimental group
2.19
1.81
1.15
Control group
2.58
2.41
2.32
Test Time
0
Fig. 1. BQT score of patients in the experimental and control groups (test time 1, pretest; 2, second week; 3, fourth week).
use between the experimental group and the control group. At baseline the ratio between the two groups was significantly different; that is, the analgesics use ratio of the experimental group was significantly higher than that of the control group. The control group showed no maturation effect in either the second or fourth weeks. However, the reduction slope of the experimental group was significantly larger than that of the control group in the fourth week (p = 0.0482) after adjusting for the treatment status effect (Fig. 4; Table 3). Therefore, the pain education program had a significant effect on improving the self-reported measure
1
2
3
Experimental group
2.21
1.31
0.99
Control group
2.69
2.55
2.48
Test Time
Fig. 2. BQT score of family carer in the experimental and control groups (test time 1, pretest; 2, second week; 3, fourth week).
of medication adherence and the ratio of analgesics use by patients. 3.6. Determining whether the pain education program reduced the worst pain intensity in patients The worst pain scores between the experimental and control groups at baseline were not significantly different. The worst pain scores for the control group patients in the second and fourth weeks were significantly lower than at baseline (p = 0.01 and 0.0008, respectively),
Table 2 GEE model of the BQT scores for patients and family carers Variable
Regression coefficient
Standard deviation
95% confidence limits
BQT scores of patients Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
2.5823 0.3945 0.1740 0.2600 0.5966 0.7794 0.2096
0.1608 0.1917 0.0872 0.1009 0.1347 0.1670 0.1582
2.2671 0.7702 0.3448 0.4577 0.8606 1.1068 0.5195
BQT scores of family carers Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
2.6949 0.4773 0.1370 0.2051 0.7633 1.0101 0.1025
0.1720 0.1968 0.0717 0.0521 0.1301 0.1299 0.1530
2.3578 0.8630 0.2776 0.3071 1.0182 1.2646 0.4025
Z
p
2.8975 0.0188 0.0032 0.0623 0.3326 0.4520 0.1004
16.06 2.06 2.00 2.58 4.43 4.67 1.32
<0.0001 0.0396* 0.0459* 0.0100* <0.0001* <0.0001* 0.1852
3.0321 0.0915 0.0036 0.1030 0.5084 0.7555 0.1974
15.67 2.42 1.91 3.94 5.87 7.78 0.67
<0.0001 0.0153* 0.0562 <0.0001* <0.0001* <0.0001* 0.5029
Note. Group 1, for experimental group; 0, for control group. Visit 0, for the pretest; 1, for the second week; 2, for the fourth week. Intercept, baseline score in controls. Group 1 vs. Group 0, difference between experimental and control group at baseline. Visit 1 vs. Visit 0, change between visit 0 and visit 1 in controls. Visit 2 vs. Visit 0, change between visit 0 and visit 2 in controls. Interaction of Visit 1 and Group, difference between experimental and control group in change visit 0 visit 1. Interaction of Visit 2 and Group, difference between experimental and control group in change visit 0 visit 2. The change in the experimental group is given by the change in the control group plus the interaction term. * p < 0.05.
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demonstrating a maturation effect. However, the reduction slope of the experimental group was significantly larger than that of the control group in the fourth week (p = 0.0295) after adjusting for the treatment status effect. Therefore, the pain education program was effective in reducing pain interference in patients (Fig. 6; Table 4).
Medication Adherence Score in Experimental Group and Control Group 5 4 Medication Adherence Score
3 Experimental group
2 1 0 1
2
3
Experimental group
0.61
2.23
2.86
Control group
0.88
1.11
1.35
277
Control group
4. Discussion
Test time
Fig. 3. Medication adherence scores in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
thereby demonstrating a maturation effect. However, the reduction slope of the experimental group was significantly larger than that of the control group in the fourth week (p = 0.0386) after adjusting for the treatment status effect. This result shows that the pain education program effectively lowered the worst pain intensity in patients (Fig. 5; Table 4). 3.7. Determining whether the pain education program reduced pain interference in patients The pain interference scores between the experimental and control groups at the baseline collection were not significantly different. The pain interference scores for the control group patients in the fourth week were significantly lower than at baseline (p < 0.0001), thereby
Patients and family carers’ concerns about the use of analgesics have been identified as barriers to management of cancer pain in Taiwan (Lin and Ward, 1995; Lin, 2000; Lin et al., 2000). Educational programs have been documented as being effective in reducing barriers and increasing the compliance of cancer pain patients (Jones et al., 1984; Rimer et al., 1987; Ferrell et al., 1994) and of non-cancer pain patients (Lorig et al., 1987; Mullen et al., 1987; Lorig and Holman, 1989; Lorig et al., 1989; Lindorth et al., 1995). To date, however, educational programs about pain management have been directed primarily at patients. Limited efforts have been directed toward developing a pain education program for both family carers and patients and in evaluating its long-term effectiveness in overcoming patient and carer barriers and improving pain treatment. Involvement of both patients and their family carers in pain educational programs is important given the fact that patient and carer concerns are significantly correlated and ultimately related to the adequacy of patient pain treatment (Lin, 2000). In the second and fourth weeks after the intervention, barrier scores of both patients
Table 3 GEE model of medication adherence and analgesics use by patients Variable
Regression coefficient
Standard deviation
95% confidence limits
Z
p
Medication adherence Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
0.8751 2.0681 0.2333 0.4706 1.3917 1.7794 0.1195
0.2878 0.3034 0.1807 0.1538 0.3529 0.3325 0.2555
0.3110 0.8629 0.1209 0.1692 0.6999 1.1277 0.3814
1.4392 0.3266 0.5875 0.7721 2.0834 2.4310 0.6203
3.04 0.88 1.29 3.06 3.94 5.35 0.47
0.0024 0.3769 0.1967 0.0022* <0.0001* <0.0001* 0.6402
Analgesic use Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
0.6651 0.1293 0.0177 0.0245 0.0753 0.1475 0.0092
0.0598 0.0622 0.0457 0.0614 0.0554 0.0746 0.0412
0.5479 0.0074 0.0718 0.1448 0.0333 0.0012 0.0715
0.7823 0.2512 0.1072 0.0958 0.1839 0.2937 0.0900
11.12 2.08 0.39 0.40 1.36 1.98 0.22
<0.001 0.0376 0.6980 0.6894 0.1742 0.0482* 0.8225
Note. Group 1, for the experimental group; 0, for the control group. Visit 0, for the pretest; 1 for the second week; 2 for the fourth week. Intercept, baseline score in controls. Group 1 vs. Group 0, difference between experimental and control group at baseline. Visit 1 vs. Visit 0, change between visit 0 and visit 1 in controls. Visit 2 vs. Visit 0, change between visit 0 and visit 2 in controls. Interaction of Visit 1 and Group, difference between experimental and control group in change visit 0 visit 1. Interaction of Visit 2 and Group, difference between experimental and control group in change visit 0 visit 2. The change in the experimental group is given by the change in the control group plus the interaction term. * p < 0.05.
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Ratio of Analgesics Use in Experimental Group and Control Group
1 0.8 Ratio of Analgesics Use
0.6 Experimental group
0.4 0.2
Control group
0 1
2
3
Experimental group
0.8
0.9
0.93
Control group
0.67
0.69
0.64
Test time
Fig. 4. Ratio of analgesics use in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
and family carers in the experimental group were significantly lower than those of the control group after controlling for pre-intervention differences and maturation effects. These barrier scores demonstrate that, whether short-term or long-term, barriers to scheduled analgesics use in the experimental group were lower than in the control group. Despite the fact that the control group received no patient and family education program, this group demonstrated a maturation effect in barrier scores, regardless of it being in the second or fourth week after the initial data collection. This maturation effect might be due to the fact that because of ethical considerations, any questions related to analgesic use were answered in detail despite the fact that this group had not participated in the pain education intervention. In contrast, both patients and their families in the experimental group were simultaneously provided a pain education program and any misconceptions about analgesics use were constantly clarified through the education program. Patients and family members’ concerns about analgesics use are closely interrelated (Lin, 2000). When a
Worst Pain in Experimental Group and Control Group
Worst Pain Intensity
7 6 5 4 3 2
Experimental group control group
1
2
3
Experimental group
6.02
4.6
3.19
control group
6.19
5.6
4.69
Test time
Fig. 5. Worst pain in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
family member has correct knowledge about analgesics, that individual becomes a more accurate spokesperson and better carer for homecare cancer patients and can help healthcare workers monitor and evaluate the effectiveness of pain management. Therefore, including family members in pain education program is beneficial to the effectiveness of pain education interventions. Failure of pain management is often due to reluctance to administer analgesics according to the dose and time interval prescribed by physicians because of patient or family carer concerns about analgesic use (Ward et al., 1993; AHCPR, 1994; Lin, 2000; Lin et al., 2000; Gunnarsdottir et al., 2002). If patients do not take analgesics according to the prescribed schedule and dosage, pain management becomes ambiguous because drug efficacy or dosage becomes difficult to evaluate and the amount of drug titration for pain management becomes even more difficult to determine. In the present study, medication adherence scores of the two groups at the pretest showed that patients’ adherence to a prescribed medication schedule was generally inadequate. About 75% of the experimental group and 70% of the control group belonged to the low-adherence group (0–1). Therefore, medication adherence in Taiwanese patients needs further improvement. In this study, the patient and family pain education program effectively improved medication adherence and the analgesic use ratio after controlling for pre-intervention differences and maturation effects, and these results are consistent with outcomes of other studies. Rimer et al. (1987) found that patients who received pain education had better adherence to medication schedules than did patients who did not receive education. In addition, patients who received pain education did not self-terminate their medication when the pain lessened. Ferrell et al. (1993) presented a systemic pain education program to 40 pairs of elderly cancer patients and their families and found a significant increase in medication adherence, an increase in knowledge of analgesics, and an increase in scheduled use of medication as opposed to an as needed approach. In this study, the patient and family pain education program also effectively reduced levels of worst pain in patients in the fourth week after the intervention when controlling for pre-intervention differences and maturation effects. Levels of worst pain in patients also decreased in the control group as time progressed, (i.e., maturation effect) but there was a statistically significant difference in levels of worst pain between the two groups in the fourth week, with the experimental group showing a greater decrease in worst pain. Worst pain levels may have decreased in the control group because patient and family carer questions about analgesics use were answered even though no education program was provided, resulting in a decrease of barriers to analgesics use and an increase in adherence to a pre-
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279
Table 4 GEE model of worst pain intensity and pain interference in patients Variable
Regression coefficient
Standard deviation
95% confidence limits
Z
p
Worst pain intensity Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
6.1907 0.1657 1.0333 1.5039 0.3860 1.3348 0.1183
0.5083 0.5640 0.4011 0.4474 0.6025 0.6453 0.4048
5.1945 1.2712 1.8194 2.3808 1.5669 2.5996 0.9116
7.1869 0.9398 0.2473 0.6271 0.7949 0.0700 0.6751
12.18 0.29 2.58 3.36 0.64 2.07 0.29
<0.0001* 0.7689 0.0100* 0.0008* 0.5217 0.0386* 0.7701
Pain interference Intercept Group 1 vs. Group 0 Visit 1 vs. Visit 0 Visit 2 vs. Visit 0 Interaction of Visit 1 and Group Interaction of Visit 2 and Group Treatment status (yes vs. no)
4.3733 0.0358 0.6930 1.5146 0.9660 1.2373 0.2317
0.6116 0.6959 0.4154 0.3607 0.5478 0.5685 0.4982
3.1746 1.3281 1.5072 2.2215 2.0398 2.3516 0.7447
5.5720 1.3997 0.1212 0.8077 0.1077 0.1230 1.2081
7.15 0.05 1.67 4.20 1.76 2.18 0.47
<0.0001 0.9589 0.0953 <0.0001* 0.0778 0.0295* 0.6418
Note. Group 1, for the experimental group; 0, for the control group. Visit 0, for the pretest; 1, for the second week; 2, for the fourth week. Intercept, baseline score in controls. Group 1 vs. Group 0, difference between experimental and control group at baseline. Visit 1 vs. Visit 0, change between visit 0 and visit 1 in controls. Visit 2 vs. Visit 0, change between visit 0 and visit 2 in controls. Interaction of Visit 1 and Group, difference between experimental and control group in change visit 0 visit 1. Interaction of Visit 2 and Group, difference between experimental and control group in change visit 0 visit 2. The change in the experimental group is given by the change in the control group plus the interaction term. * p < 0.05.
scribed medication regimen. Worst pain has often been used clinically as an indicator of treatment and is the most highly correlated to pain interference (Serlin et al., 1995). In a study that investigated the influence of pain severity on patients’ quality of life, it was found that worst pain could be used as a major indicator for evaluating the quality of life (Wang et al., 1999). Consequently, by improving the worst pain of patients, pain interference and quality of life can also possibly be improved. A past study on the effects of pain education of patients failed to show a significant reduction in worst pain levels (Chang et al., 2002). Ferrell et al. (1993) found that a pain education program could reduce the overall average pain intensity. Pain Interference in Experimental Group and Control Group 5 4 Average Pain Interference
3
Experimental group
2
Control group
1 0 1
2
3
Experimental group
4.33
2.67
1.58
Control group
4.37
3.68
2.86
Test time
Fig. 6. Pain interference in the experimental and control groups (1, pretest; 2, second week; 3, fourth week).
The patient and family pain education program significantly reduced levels of pain interference in the fourth week after the intervention in this study even though a maturation effect was also apparent in the control group. Some large-scale, long-term studies discovered that pain education programs do not display significant results in improving pain interference with general activities or patients’ sleep or mood (de Wit et al., 1997; Wells et al., 2003). The present research showed significant difference in reduction slopes of pain interference between the two groups only in the fourth week, confirming that improved pain interference might not be achieved in a short time period. The improvement of pain interference or pain intensity in the control group (i.e., maturation effect) may be due to the appropriate use of analgesics and rapid titration. To date, most studies on pain education have primarily focused only on patients, or provided only a single pain education session (Ferrell et al., 1994; Oliver et al., 2001; Chang et al., 2002) rather than an on-going evaluation. Oliver et al. (2001) discovered that a pain education program can reduce pain frequency in patients, but another study (Chang et al., 2002) found that regardless of whether or not patients participated in a pain education program, there were no significant findings on pain intensity or pain interference after 2 weeks of intervention. A larger study found a significant difference in average pain and present pain but no significant difference in worst pain (de Wit et al., 1997). A large-scale, long-term study that offered pain education to both patients and their families by telephone and telephone interviews showed, after 6 months of
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intervention, no difference in pain intensity of patients (Wells et al., 2003). These results may suggest that the telephone is not as effective as face-to-face interviews nor multiple health education programs in pain education. The success achieved by this study in pain education for Taiwanese patients and family carers may be due to ongoing reinforcement and evaluation, faceto-face interviews, and most importantly, simultaneous involvement of patients and their family carers. The beneficial effect of this pain education on pain scores for those participants in the experimental group could be due to a placebo effect; however, such impact has not been commonly observed in other pain education studies (de Wit et al., 1997; Chang et al., 2002; Wells et al., 2003). The length of time the pain education achieved in this study will remain effective is not known because the long-term effects of pain education interventions have not been well documented (de Wit et al., 1997; Wells et al., 2003). We hypothesize that the beneficial effects of pain education demonstrated by this study may be sustained over a longer period of time if face-to-face reinforcement for both patients and family carers is periodically continued. In conclusion, this study is the first to examine the effect of a patient and family pain education intervention program in Taiwan and to analyze the results using the Generalized Estimating Equations (GEE). Results of this study demonstrate that an on-going, face-to-face pain education program with explanatory answers to analgesic-related questions provided simultaneously to patients and their family carers reduces barriers pain management, increases adherence to scheduled analgesic use, and decreases the worst pain score and the level of pain interference. This type of educational program if incorporated into future clinical practice could have great potential to improve the quality of pain management for cancer patients.
Acknowledgments This study was funded by the NSC 89-2314-B-083069 from the National Science Council in Taiwan. The authors thank Ms. Denise Dipert for her careful review and editing this manuscript.
References Agency for Health Care Policy and Research, 1994. Management of care pain. AHCPR Publ. No. 94-0592, Rockville, MD: AHCPR, US Department of Health and Human Services. Bland M. An introduction to medical statistics. Oxford: Oxford University Press; 2000. Buccheri G, Ferrigno D, Tamburini M. Karnofsky and ECOG performance status scoring in lung cancer: a prospective, longitudinal study of 536 patients from a single institution. Eur J Cancer 1996;32:1135–41.
Chang MC, Chang YC, Chiour JF, Tsou TS, Lin CC. Overcoming patient-related barriers to a cancer pain management for home care patients. Cancer Nurs 2002;25:470–6. Chelf JH, Agre P, Alxelrod A, Cheney L, Cole DD, Conrad K, et al. Cancer-related patient education: an overview of the last decade of evaluation and research. Oncol Nurs Forum 2001;28:1139–47. de Wit R, van Dam F, Zandbelt L, van Buura A, van der Heijden K, Leenhouts G, et al. A pain education program for chronic cancer pain patients: follow up results a randomized controlled trial. Pain 1997;73:55–69. Ferrell BR, Ferrell BA, Ahn C, Tran K. Pain management for elderly patients with cancer at home. Cancer 1994;74(Suppl.):2139–46. Ferrell BR, Grant M, Chan J, Ahn C, Ferrell BA. The impact of cancer pain education on family caregivers of elderly patients. Oncol Nurs Forum 1995;22:1211–8. Ferrell BR, Rhiner M, Ferrell BA. Development and implementation of pain educational program. Cancer 1993;72(Suppl.):3426–35. Ferrell BR, Rivaera L. Cancer pain education for patients. Semin Oncol Nurs 1997;13:42–8. Gunnarsdottir S, Donovan HS, Serlin RC, Voge C, Ward S. Patientrelated barriers to pain management: the barriers questionnaire II (BQ-II). Pain 2002;99:385–96. Jones W, Rimer B, Levy M, Kinman J. Cancer patients’ knowledge, beliefs, and behavior regarding pain control regimens: implications for education programs. Patient Educ Couns 1984;5:159–64. Liang KY, Zeger SL. Longitudinal data analysis using generalized liner models. Biometrika 1986;73:13–22. Lin CC. Barriers to the analgesic management of cancer pain: a comparison of attitudes of Taiwan patients and their family caregivers. Pain 2000;88:1–7. Lin CC, Wang P, Lai Y, Lin C, Tsai S, Chen TT. Identifying attitudinal barriers to family management of cancer pain in palliative care in Taiwan. Palliat Med 2000;14:463–70. Lin CC, Ward SE. Patient-related barriers to cancer pain management in Taiwan. Cancer Nurs 1995;18:16–22. Lindorth Y, Bauman A, Brooks PM, Priestley D. A 5-year follow-up of a controlled trial of an arthritis education programme. Br J Rheumatol 1995;34:647–52. Lorig K, Holman HR. Long-term outcomes of an arthritis selfmanagement study: effects of reinforcement efforts. Soc Sci Med 1989;29:221–4. Lorig K, Konkol L, Gonzales V. Arthritis patient education: a review of the literature. Patient Educ Couns 1987;10:207–52. Lorig K, Manzonson PD, Holman HR. Four-year clinical and service utilization benefits of arthritis patient education. Arthritis Rheum 1989;32:S99. Miaskowski C, Zimmer E, Barrett K, Dibble S, Wallhagen M. Difference in patients’ and family caregivers’ perceptions of the pain experience influence patient and caregiver outcomes. Pain 1997;72:217–26. Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care 1986;24:67–74. Mullen PD, Laville EA, Biddle AK, Lorig K. Efficacy of psychoeducational interventions in pain, depression and disability in people with arthritis: a meta-analysis. J Rheumatol 1987;14: 33–9. Oliver JW, Kravitz RL, Kaplan SH. Individualized patient education and coaching to improve pain control among cancer outpatients. J Clin Oncol 2001;19:2206–12. Redinbaugh EM, Baum A, DeMoss C, Fello M, Arnold R. Factors associated with the accuracy of family caregiver estimates of patient pain. J Pain Symptom Manage 2002;23:31–8. Rimer B, Levy MH, Keinta MK, Fox L, Engstrom PE, MacElwee N. Enhancing cancer pain control regimens through patient education. Patient Educ Couns 1987;10:267–77.
C.-C. Lin et al. / Pain 122 (2006) 271–281 Serlin RC, Mendoza TR, Nakamura Y, Edwards KR, Cleeland CS. When is cancer pain mild, moderate or severe? Grading pain severity by its interference with function. Pain 1995;61: 277–84. Wang XS, Cleeland CS, Mendoza TR, Engstrom MC, Liu S, Xu G, et al. The effects of pain severity on health-related quality of life. Cancer 1999;86:1848–55. Wang XS, Mendoza TR, Gao SZ, Cleeland CS. The Chinese version of the Brief Pain Inventory (BPI-C): its development and use in a study of cancer pain. Pain 1996;67:407–16.
281
Ward SE, Goldberg N, McCauley VM, Mueller C, Nolan A, Plank DP, et al. Patient-related barriers to management of cancer pain. Pain 1993;52:319–24. Wells N, Hepworth JT, Murphy BA, Wujcik D, Johnson R. Improving cancer pain management through patient and family education. J Pain Symptom Manage 2003;25:344–56. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics 1986;42:121–30. Zeger SL, Liang KY. An overview of methods for the analysis of longitudinal data. Stat Med 1992;11:1825–30.