- Email: [email protected]
Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial
Radiotherapy and Oncology 96 (2010) 254–258
Contents lists available at ScienceDirect
Radiotherapy and Oncology journal homepage: www.thegreenjournal.com
Randomized phase III trial
Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial Yvonne Zissiadis a,*, Emily Harper b, Elizabeth Kearney a a
Perth Radiation Oncology, Royal Perth Hospital, Australia; b Department of Clinical Psychology, University of Western Australia, Australia
a r t i c l e
i n f o
Article history: Received 27 May 2009 Received in revised form 1 June 2010 Accepted 2 June 2010 Available online 1 July 2010 Keywords: Patient satisfaction Anxiety Communication
a b s t r a c t Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients’ anxiety levels. The secondary aim was to determine the impact of this information on patients’ satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients’ anxiety scores or satisfaction levels. The patients were generally very satisfied with the information they received but less satisfied with the information on lifestyle issues. Ó 2010 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 96 (2010) 254–258
Cancer itself is a threatening experience and the acquisition of more information has been seen to be associated with higher levels of satisfaction, compliance and psychological adjustment [1,2]. D’haese et al., 2000 [3] found that lack of information can lead to an exacerbation of fear existing from a cancer diagnosis, diminishing the patient’s belief in the benefits of such treatment, and to misinterpretation of the symptoms and side effects the patient will experience. Patients undergoing radiation therapy have multiple fears, anxieties, stress and expectations [4,5]. The acquisition of information is one step in the journey of a patient with cancer embarking on treatment. Clinicians have shown that patients involved in making treatment decisions gain benefits over others [1]. Ensuring that patients are given relevant information in order * Corresponding author. Address: Perth Radiation Oncology, 24 Salvado Rd, Wembley, 6014 WA, Australia. E-mail address: [email protected] (Y. Zissiadis). 0167-8140/$ - see front matter Ó 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.radonc.2010.06.002
to more actively involve them in treatment decision-making is an important step in the treatment process. Häggmark et al., 2001 [6] showed that in the Swedish population, patients who received standard information in addition to attending a nurses’ educational group and repeated individual information were significantly more satisfied with the information than the other two groups who received standard information with or without a brochure. There was however no difference in the other outcomes of anxiety and depression. In this group of patients no relationship between level of anxiety and satisfaction with information was found. In contrast, Thomas et al., 1999 [1], noted that many empirical studies support the finding that provision of more information is associated with higher levels of satisfaction and psychological adjustment, in particular, lower levels of anxiety and depression. A pilot study conducted at the Perth Radiation Oncology Centre [7] revealed that patients were satisfied with information they
Y. Zissiadis et al. / Radiotherapy and Oncology 96 (2010) 254–258
received regarding their illness (94%) and treatment toxicity (81%) but were much less satisfied with the information they received regarding lifestyle issues (41%) such as diet, exercise, natural/alternative therapies, smoking and practical issues (56%) such as parking and costs. One in five patients starting radiotherapy at the Beatson Oncology Centre, Glasgow, was not satisfied with the information they had received [8]. Although breast cancer patients were provided with more information than those with other cancers, they were not necessarily more satisfied as a result. Age, sex and depression were predictors of dissatisfaction in this population and those patients who said there had been many differences in what they had been told by health professionals were more likely to be anxious. Once new information is introduced into the clinic setting, it is important to have a simple and practical audit tool to assess its impact on patient satisfaction. In both our pilot study [7] and this current study, the information satisfaction questionnaire (ISQ) described by Thomas et al. [9] was used. It allowed us to address the deficiencies in information shown in our pilot study, when formulating this study. The purpose of this study was to determine the impact of intensive written information addressing lifestyle and practical issues in addition to treatment-related information, on patients’ anxiety levels. The secondary aim was to determine the impact of the intensive written information on the patients’ satisfaction levels. Materials and methods Sample Eligible patients consisted of those patients with a pathological diagnosis of cancer having radical radiotherapy at the Perth Radiation Oncology Centre at either the private facility at Wembley or the public facility at Royal Perth Hospital. Patients had to have a reasonable grasp of English in order to complete the questionnaires and have signed the informed consent. Relatives were not permitted to fill out the questionnaires for the patients. Measures Measures of anxiety Anxiety (both state and trait) was measured by the State Trait Anxiety Index (STAI) Questionnaire [10] (Supplementary data, Appendix 1). The questionnaire was given at three time intervals. The first interval was at the initial consultation with the radiation oncologist (prior to seeing the doctor) where baseline demographics and baseline anxiety scores were recorded. The second interval
was at the time of radiotherapy simulation (pre-RT) and the third at the completion of radiotherapy (post-RT). Measure of satisfaction Patient satisfaction was measured by the information satisfaction questionnaire (ISQ) at the time of radiotherapy simulation (pre-RT). This is a single page, validated questionnaire used to specifically measure the patients’ satisfaction scores with the following aspects: explanation of illness, information on side effects, other treatment available, advice on lifestyle, other practical dayto-day issues and overall information provided (Supplementary data, Appendix 2). The ISQ is available from the website www. cancernet.co.uk/questionnaire.htm. Trial design The eligible patients were invited to participate in this study at the time of their initial consultation with the radiation oncologist. They were approached while in the waiting room awaiting their first consultation. If the patient agreed to participate, they were consented and given a baseline STAI questionnaire to complete. The patients then had their first consultation with the radiation oncologist. Following the consultation, they were randomized to receive the intensive information package or the standard information package. The study design is shown in Fig. 1. The intensive information package consisted of a specially designed tumour-specific booklet outlining what is involved in receiving radiation therapy to their specific tumour site including details regarding planning, treatment and toxicities. In addition, they received a specially designed booklet outlining lifestyle issues such as diet, exercise, natural therapies and practical issues such as costs and parking. A third general booklet on radiotherapy provided by the Cancer Council of WA was also included. These patients were then contacted by telephone by our research nurse one week following their consultation. She specifically interviewed them regarding whether they had read the information, whether they had any further questions and was instructed to obtain their feedback. The patients randomized to the standard consultation received an information package consisting of the general book on radiotherapy generated by the Cancer Council of WA. This booklet addresses how radiation therapy works, how it is given and a brief, general overview of toxicity. It is not tumour-site specific nor does it address any lifestyle issues. The second questionnaires measuring both anxiety and satisfaction with the information received (STAI and ISQ) were given to the patients when they returned for their radiotherapy simulation/
Consultation with Radiation Oncologist Baseline STAI questionnaire
Standard information
Intensive information
( ISQ and STAI questionnaire 2 AT TIME OF SIMULATION)
255
+ nurse phone call one week later (ISQ and STAIquestionnaire 2 AT TIME OFSIMULATION)
Curative Radiation Therapy
Curative Radiation Therapy
STAI questionnaire 3
STAI questionnaire 3
Fig. 1. Trial design.
256
Impact of more intensive information
planning. This was at least one week following the initial consultation. The third questionnaire (STAI) was given to the patients at the time of completion of radiotherapy.
Statistical methods Sample size The aim was for a sample size of 106 patients in each arm based on a 5% type I error and 80% power with a standard deviation of 13 to detect a 5-point difference in mean State anxiety score between the two arms. Statistical analysis was performed at the completion of the study.
Anxiety scores The mean anxiety scores at the three time intervals are shown in Figs. 2 and 3. There was no significant difference in either the State or Trait Anxiety scores between the two information groups at any of the three time intervals (ANOVA, p > 0.05). No significant difference was found in mean scores within each group between each of the three time intervals (ANOVA, p > 0.05). Factors such as personality type, type of cancer, breast cancer versus non-breast cancer and sex did not have any influence on the mean anxiety scores.
Randomization The method of randomization was by block design whereby the information booklets were placed inside envelopes which are then sealed and randomly sequenced in blocks of 10. No stratification factors were used for randomization. Statistical analysis The difference in mean State and Trait Anxiety scores at each time point from baseline was calculated. The 2-sample t-test was used to compare the two groups. The Chi-square test was used to compare the mean ISQ scores between the two groups. Multiple linear regression analysis was performed to look at the predictive value of baseline characteristics such as sex, tumour type, participation in clinical trial and personality type according to their information needs.
Fig. 2. Mean state anxiety scores for standard and intensive information (error bars are 95% confidence interval of the mean).
Results One hundred and ninety-four patients were randomized to the study. One hundred and two patients received the standard information and 92 patients received the intensive information package. The patient characteristics are shown in Table 1. The majority of patients were female (72%) and had breast carcinoma (65%). Of the initial 194 patients, 152 patients completed the information needs section of the ISQ form and 161 completed the ISQ questions 1–6. The results of the information needs question showed that 129 patients (85%) wanted all available information and to be involved in decision-making, 17 patients (11%) wanted only positive information about their illness and 6 patients (4%) wanted only limited information and would prefer the doctor to make treatment decisions. Fig. 3. Mean trait anxiety scores for standard and intensive information (error bars are 95% confidence interval of the mean). Table 1 Patient characteristics.
Age (mean, range) Sex Male Female Tumour site Breast Lung Prostate Gynaecological Rectum Lymphoma Skin
Standard information (n = 102)
Intensive information (n = 92)
58.1 yrs (25–83)
58.8 yrs (32–82)
32 70
23 69
66 7 20 1 7 0 1
61 5 9 4 9 1 3
Table 2 Mean ISQ scores for each category. ISQ question
Standard information
Intensive information
Explanation of illness Information on side effects Discussion of treatment options/ clinical trials Discussion of lifestyle issues Discussion of practical issues Overall information provided
3.42 3.25 3.26
3.42 3.18 3.15
2.90 2.93 3.27
2.88 2.93 3.22
Scoring: 0 = very unsatisfied, 1 = unsatisfied, 2 = fair, 3 = satisfied, 4 = very satisfied.
257
Y. Zissiadis et al. / Radiotherapy and Oncology 96 (2010) 254–258 Table 3 Mean ISQ scores for each personality type.
*
ISQ question
Like limited information and prefer Dr. to decide (n = 6)
Like positive information only (n = 17)
Like all available information and be involved in decisions (n = 129)
Explanation of illness Information on side effects Discussion of treatment options/clinical trials Discussion of lifestyle issues Discussion of practical issues Overall information provided
3.48 3.23 3.38 2.95 2.95 3.27
3.33 3.24 3.12 2.82 2.59 3.12
3.17 3.33 2.83* 2.50* 3.17 3.33
Significant difference in mean scores (Chi-squared test p < 0.05).
Satisfaction scores The majority of patients were satisfied or very satisfied with the information they received on their illness, side effects, other treatment options, practical issues and overall information given. Fewer were satisfied/very satisfied with discussion of lifestyle issues. There was no significant difference in mean satisfaction scores between the two information groups using Chi-squared statistics (p > 0.05) as shown in Table 2. When the mean scores for individual questions were analyzed according to the patients’ information needs (Table 3), the group of patients who wanted only limited information and preferred the doctor to make treatment decisions were significantly less satisfied with the information they received on other treatment options and lifestyle issues (Chi-squared statistics, p < 0.05).There was no significant difference in either information arms in this small group of patients (n = 6) who wanted only limited information. The mean total satisfaction score for the patients who received the standard consultation was 19.03 with a standard deviation (SD) of 3.14. For the patients who received the intensive information, their mean total score was 18.78 with a SD of 3.92. There was no statistically significant difference between these total scores (p > 0.05).The recommendation for scores of 15–19 is that minor fine tuning is required only.
Discussion Our population was generally very satisfied with the information they received prior to embarking on a course of radiation therapy. The addition of more intensive information, in both the written and verbal forms, did not reduce anxiety in our population. It is likely that patients source the information that they individually require from a number of different sources and therefore can supplement the information they are given in the clinic by other sources such as the internet and cancer support groups. This is most likely the reason why intensifying the information given also did not improve patient satisfaction. Hahn et al., 2005 [11] assessed the information needs of radiation oncology patients using a self-administered 5 question questionnaire concerning specific informational needs. Subjects were asked to rate the importance of information on potential side effects, side effects to report to their doctor or nurse, prevention of side effects, what will happen during radiation therapy and how they will feel during radiation therapy. No question addressed the need for information on lifestyle issues and alternative therapies. In our earlier pilot study [7], we found that the information on side effects and what will happen during radiation therapy was well addressed but patients wanted and needed more information on lifestyle and practical issues. Even after addressing this deficit in this study, patients still felt less satisfied with the information on lifestyle issues.
The medium in which this information is conveyed to the patient may be a factor in their satisfaction. The use of a patient education video in addition to standard written educational materials produced high levels of satisfaction as reported by Hahn et al. [11]. Perhaps combining information conveying mediums can lead to greater patient satisfaction however very few studies have really addressed the need for adding information regarding lifestyle issues. Other means of conveying information published include the use of an orientation programme. Adding an orientation programme to the standard verbal and written information given to new radiation oncology patients did not have a significant effect on state anxiety, general distress, objectively measured treatment adherence, the use of most ancillary services and the knowledge about radiation therapy for patients or family members [12]. Satisfaction with care in patients assigned to receive the orientation programme was slightly higher however the satisfaction was high in both groups similar to our findings. The orientation programme did however increase the use of psychological counselling services and of outside support services. There is little information in the literature regarding the importance of lifestyle issues to patients. Siekkinen et al., 2008 [13], found that patients attending outpatient radiotherapy in a university hospital in Finland rated the information received on alternative treatments low. High ratings were given to professionalism in nursing, talking with patients and written information. Once again, it appears that centres worldwide are finding that information on lifestyle issues such as alternative therapies, diet and exercise is not being adequately conveyed to patients [7,13]. This may partly be due to the physicians and nurses not having the confidence to discuss up to date findings in these areas. Considerable work has been done assessing cancer patients’ unmet needs regarding supportive care during the diagnostic, treatment and follow-up phases of the cancer journey [14,15,17]. These are the needs that are deemed important and unsatisfied by patients [16]. Supportive care includes the provision of services to meet physical, psychological, social, information and spiritual needs. Psychosocial supports, spiritual and a number of tools have been developed to assess these unmet needs. In this project, we focused primarily on the information needs of patients about to embark on a course of curative radiation therapy. We found that there is a need for more or better information on lifestyle issues. It is more likely that the need for information regarding lifestyle issues increases at the end of radiotherapy. Once a patient has completed their radiotherapy, they are often at the end of their cancer therapy and will be discharged to a follow-up programme. It is then that they often specifically ask about what active measures they can take to reduce the risk of cancer recurrence. This is the time where lifestyle issues, particularly for breast and bowel cancer, are of paramount importance. More research needs to be done to address the issue
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of the impact of discussion of lifestyle factors such as diet, exercise and alternative therapies. This appears to be an area of need and one which may lead to an improvement in the quality of cancer care if addressed adequately. Acknowledgements The authors want to express their gratitude to research assistants, Louise Tusak and Katie Harper, for their help with the distribution of questionnaires. They also thank Ms. Andrea Provis, for her contribution in the conception of this study. This work was partially supported by a research grant from the Royal Australian and New Zealand College of Radiologists.
Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.radonc.2010.06.002. References [1] Thomas R, Thornton H, Mackay J. Patient information materials in oncology: are they needed and do they work? Clin Oncol 1999;11:225–31. [2] Rainey LC. Effects of preparatory patient education for radiation oncology patients. Cancer 1985;56:1056–61. [3] D’haese S, Vinh-hung V, Bijdekerke P, et al. The effect of timing of the provision of information on anxiety and satisfaction of cancer patients receiving radiotherapy. J Cancer Educ 2001;15:223–7.
[4] Andersen BL, Karlsson JA, Andersson B, Tewfik HH. Anxiety and cancer treatment: response to stressful radiotherapy. Health Psychol 1984;3: 535–51. [5] Frith B. Giving information to radiotherapy patients. Nurs Stand 1991;34:33–5. [6] Häggmark C, Bohman L, Ilmoni-Brandt K, Näslund I, Sjödén P-O, Nilsson B. Effects of information supply on satisfaction with information and quality of life in cancer patients receiving curative radiation therapy. Patient Educ Couns 2001;45:173–9. [7] Zissiadis Y, Harper E, Kearney E, MacDonald L, Provis A, Dhaliwal S. Patient satisfaction in radiation oncology. Australas Radiol 2007;50:412. [8] Jones Ray, Pearson Janne, McGregor Sandra, Harper Gilmore W, Atkinson Jacqueline M, Barrett Ann, et al. Cross sectional survey of patients’ satisfaction with information about cancer. BMJ 1999;319:1247–8. [9] Thomas R, Kaminski E, Stanton E, Williams M. Measuring information strategies in oncology – developing an information satisfaction questionnaire. Eur J Cancer Care 2004;13:65–70. [10] Spielberger CD, Gorsuch RL, Lushene RE. Manual for the state-trait anxiety inventory. Palo Alto, CA: Consulting Psychologists Press; 1970. [11] Hahn CA, Fish LJ, Dunn RH, Halperin EC. Prospective trial of a video educational tool for radiation oncolog patients. Am J Clin Oncol 2005;28:609–12. [12] Cartledge Hoff A, Haaga DAF. Effects of an education program on radiation oncology patients and families. J Psychosocial Oncol 2005;23:61–79. [13] Siekkinen M, Laiho R, Ruotsalainen E, Katajisto J, Pyrhonen S, Leion-Kilpi H. Quality of care experienced by Finnish cancer patients during radiotherapy. Eur J Cancer Care 2008;17:387–8. [14] Redman S, Turner J, Davis C. Improving supportive care for women with breast cancer in Australia: the challenge of modifying health systems. Psychooncology 2003;12:521–31. [15] Sanson-Fisher R, Girgis A, Boyes A, Bonevski B, Burton L, Cook P. The unmet supportive care needs of patients with Cancer. Cancer 2000;88:226–37. [16] Soothill K, Morris SM, Harman J, Francis B, Thomas C, McIllmurray MB. The significant unmet meeds of cancer patients: probing psychosocial concerns. Supportive Care Cancer 2001;9:597–605. [17] Pigott C, Pollard A, Thomson K, Aranda S. Unmet needs in cancer patients: development of a supportive needs screening tool (SNST). Supportive Care Cancer 2009;17:33–45.
Contents lists available at ScienceDirect
Radiotherapy and Oncology journal homepage: www.thegreenjournal.com
Randomized phase III trial
Impact of more intensive written information in patients having radical radiation therapy: Results of a prospective randomized phase III trial Yvonne Zissiadis a,*, Emily Harper b, Elizabeth Kearney a a
Perth Radiation Oncology, Royal Perth Hospital, Australia; b Department of Clinical Psychology, University of Western Australia, Australia
a r t i c l e
i n f o
Article history: Received 27 May 2009 Received in revised form 1 June 2010 Accepted 2 June 2010 Available online 1 July 2010 Keywords: Patient satisfaction Anxiety Communication
a b s t r a c t Background and purpose: A diagnosis of malignancy and its treatment is a very stressful time for patients and their families. This study was conducted to determine the impact of more intensive written information on patients’ anxiety levels. The secondary aim was to determine the impact of this information on patients’ satisfaction levels. Materials and methods: This prospective randomized trial consisted of patients with a pathological diagnosis of cancer having radical radiotherapy (RT). Patients were randomized to receive the more intensive information (including written information and a telephone call from the research nurse) or not to receive the more intensive information at the time of their initial consultation with the radiation oncologist. Study questionnaires measuring anxiety (STAI form) were completed prior to their first consultation (baseline) at the time of simulation (pre-RT) and at the completion of radiotherapy. A second questionnaire assessing satisfaction with the information given (ISQ) was completed at the time of simulation prior to commencing RT. Results: One hundred and ninety-four patients were enrolled in the study. The mean age of the patients was 58.5 years and 70% of patients were female. Breast cancer (67%) was the commonest cancer. One hundred and two patients were randomized to receive the intensive information package and 92 patients received the standard consultation. There was no significant difference in mean State or Trait anxiety scores between any of the time intervals and no difference between the two information groups. There was no significant difference between the groups with regard to mean satisfaction scores with the overall information given, nor with any individual question. The satisfaction scores with lifestyle information given were lower than those for any other type of information in both randomization arms. Conclusion: More intensive information did not significantly change patients’ anxiety scores or satisfaction levels. The patients were generally very satisfied with the information they received but less satisfied with the information on lifestyle issues. Ó 2010 Elsevier Ireland Ltd. All rights reserved. Radiotherapy and Oncology 96 (2010) 254–258
Cancer itself is a threatening experience and the acquisition of more information has been seen to be associated with higher levels of satisfaction, compliance and psychological adjustment [1,2]. D’haese et al., 2000 [3] found that lack of information can lead to an exacerbation of fear existing from a cancer diagnosis, diminishing the patient’s belief in the benefits of such treatment, and to misinterpretation of the symptoms and side effects the patient will experience. Patients undergoing radiation therapy have multiple fears, anxieties, stress and expectations [4,5]. The acquisition of information is one step in the journey of a patient with cancer embarking on treatment. Clinicians have shown that patients involved in making treatment decisions gain benefits over others [1]. Ensuring that patients are given relevant information in order * Corresponding author. Address: Perth Radiation Oncology, 24 Salvado Rd, Wembley, 6014 WA, Australia. E-mail address: [email protected] (Y. Zissiadis). 0167-8140/$ - see front matter Ó 2010 Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.radonc.2010.06.002
to more actively involve them in treatment decision-making is an important step in the treatment process. Häggmark et al., 2001 [6] showed that in the Swedish population, patients who received standard information in addition to attending a nurses’ educational group and repeated individual information were significantly more satisfied with the information than the other two groups who received standard information with or without a brochure. There was however no difference in the other outcomes of anxiety and depression. In this group of patients no relationship between level of anxiety and satisfaction with information was found. In contrast, Thomas et al., 1999 [1], noted that many empirical studies support the finding that provision of more information is associated with higher levels of satisfaction and psychological adjustment, in particular, lower levels of anxiety and depression. A pilot study conducted at the Perth Radiation Oncology Centre [7] revealed that patients were satisfied with information they
Y. Zissiadis et al. / Radiotherapy and Oncology 96 (2010) 254–258
received regarding their illness (94%) and treatment toxicity (81%) but were much less satisfied with the information they received regarding lifestyle issues (41%) such as diet, exercise, natural/alternative therapies, smoking and practical issues (56%) such as parking and costs. One in five patients starting radiotherapy at the Beatson Oncology Centre, Glasgow, was not satisfied with the information they had received [8]. Although breast cancer patients were provided with more information than those with other cancers, they were not necessarily more satisfied as a result. Age, sex and depression were predictors of dissatisfaction in this population and those patients who said there had been many differences in what they had been told by health professionals were more likely to be anxious. Once new information is introduced into the clinic setting, it is important to have a simple and practical audit tool to assess its impact on patient satisfaction. In both our pilot study [7] and this current study, the information satisfaction questionnaire (ISQ) described by Thomas et al. [9] was used. It allowed us to address the deficiencies in information shown in our pilot study, when formulating this study. The purpose of this study was to determine the impact of intensive written information addressing lifestyle and practical issues in addition to treatment-related information, on patients’ anxiety levels. The secondary aim was to determine the impact of the intensive written information on the patients’ satisfaction levels. Materials and methods Sample Eligible patients consisted of those patients with a pathological diagnosis of cancer having radical radiotherapy at the Perth Radiation Oncology Centre at either the private facility at Wembley or the public facility at Royal Perth Hospital. Patients had to have a reasonable grasp of English in order to complete the questionnaires and have signed the informed consent. Relatives were not permitted to fill out the questionnaires for the patients. Measures Measures of anxiety Anxiety (both state and trait) was measured by the State Trait Anxiety Index (STAI) Questionnaire [10] (Supplementary data, Appendix 1). The questionnaire was given at three time intervals. The first interval was at the initial consultation with the radiation oncologist (prior to seeing the doctor) where baseline demographics and baseline anxiety scores were recorded. The second interval
was at the time of radiotherapy simulation (pre-RT) and the third at the completion of radiotherapy (post-RT). Measure of satisfaction Patient satisfaction was measured by the information satisfaction questionnaire (ISQ) at the time of radiotherapy simulation (pre-RT). This is a single page, validated questionnaire used to specifically measure the patients’ satisfaction scores with the following aspects: explanation of illness, information on side effects, other treatment available, advice on lifestyle, other practical dayto-day issues and overall information provided (Supplementary data, Appendix 2). The ISQ is available from the website www. cancernet.co.uk/questionnaire.htm. Trial design The eligible patients were invited to participate in this study at the time of their initial consultation with the radiation oncologist. They were approached while in the waiting room awaiting their first consultation. If the patient agreed to participate, they were consented and given a baseline STAI questionnaire to complete. The patients then had their first consultation with the radiation oncologist. Following the consultation, they were randomized to receive the intensive information package or the standard information package. The study design is shown in Fig. 1. The intensive information package consisted of a specially designed tumour-specific booklet outlining what is involved in receiving radiation therapy to their specific tumour site including details regarding planning, treatment and toxicities. In addition, they received a specially designed booklet outlining lifestyle issues such as diet, exercise, natural therapies and practical issues such as costs and parking. A third general booklet on radiotherapy provided by the Cancer Council of WA was also included. These patients were then contacted by telephone by our research nurse one week following their consultation. She specifically interviewed them regarding whether they had read the information, whether they had any further questions and was instructed to obtain their feedback. The patients randomized to the standard consultation received an information package consisting of the general book on radiotherapy generated by the Cancer Council of WA. This booklet addresses how radiation therapy works, how it is given and a brief, general overview of toxicity. It is not tumour-site specific nor does it address any lifestyle issues. The second questionnaires measuring both anxiety and satisfaction with the information received (STAI and ISQ) were given to the patients when they returned for their radiotherapy simulation/
Consultation with Radiation Oncologist Baseline STAI questionnaire
Standard information
Intensive information
( ISQ and STAI questionnaire 2 AT TIME OF SIMULATION)
255
+ nurse phone call one week later (ISQ and STAIquestionnaire 2 AT TIME OFSIMULATION)
Curative Radiation Therapy
Curative Radiation Therapy
STAI questionnaire 3
STAI questionnaire 3
Fig. 1. Trial design.
256
Impact of more intensive information
planning. This was at least one week following the initial consultation. The third questionnaire (STAI) was given to the patients at the time of completion of radiotherapy.
Statistical methods Sample size The aim was for a sample size of 106 patients in each arm based on a 5% type I error and 80% power with a standard deviation of 13 to detect a 5-point difference in mean State anxiety score between the two arms. Statistical analysis was performed at the completion of the study.
Anxiety scores The mean anxiety scores at the three time intervals are shown in Figs. 2 and 3. There was no significant difference in either the State or Trait Anxiety scores between the two information groups at any of the three time intervals (ANOVA, p > 0.05). No significant difference was found in mean scores within each group between each of the three time intervals (ANOVA, p > 0.05). Factors such as personality type, type of cancer, breast cancer versus non-breast cancer and sex did not have any influence on the mean anxiety scores.
Randomization The method of randomization was by block design whereby the information booklets were placed inside envelopes which are then sealed and randomly sequenced in blocks of 10. No stratification factors were used for randomization. Statistical analysis The difference in mean State and Trait Anxiety scores at each time point from baseline was calculated. The 2-sample t-test was used to compare the two groups. The Chi-square test was used to compare the mean ISQ scores between the two groups. Multiple linear regression analysis was performed to look at the predictive value of baseline characteristics such as sex, tumour type, participation in clinical trial and personality type according to their information needs.
Fig. 2. Mean state anxiety scores for standard and intensive information (error bars are 95% confidence interval of the mean).
Results One hundred and ninety-four patients were randomized to the study. One hundred and two patients received the standard information and 92 patients received the intensive information package. The patient characteristics are shown in Table 1. The majority of patients were female (72%) and had breast carcinoma (65%). Of the initial 194 patients, 152 patients completed the information needs section of the ISQ form and 161 completed the ISQ questions 1–6. The results of the information needs question showed that 129 patients (85%) wanted all available information and to be involved in decision-making, 17 patients (11%) wanted only positive information about their illness and 6 patients (4%) wanted only limited information and would prefer the doctor to make treatment decisions. Fig. 3. Mean trait anxiety scores for standard and intensive information (error bars are 95% confidence interval of the mean). Table 1 Patient characteristics.
Age (mean, range) Sex Male Female Tumour site Breast Lung Prostate Gynaecological Rectum Lymphoma Skin
Standard information (n = 102)
Intensive information (n = 92)
58.1 yrs (25–83)
58.8 yrs (32–82)
32 70
23 69
66 7 20 1 7 0 1
61 5 9 4 9 1 3
Table 2 Mean ISQ scores for each category. ISQ question
Standard information
Intensive information
Explanation of illness Information on side effects Discussion of treatment options/ clinical trials Discussion of lifestyle issues Discussion of practical issues Overall information provided
3.42 3.25 3.26
3.42 3.18 3.15
2.90 2.93 3.27
2.88 2.93 3.22
Scoring: 0 = very unsatisfied, 1 = unsatisfied, 2 = fair, 3 = satisfied, 4 = very satisfied.
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Y. Zissiadis et al. / Radiotherapy and Oncology 96 (2010) 254–258 Table 3 Mean ISQ scores for each personality type.
*
ISQ question
Like limited information and prefer Dr. to decide (n = 6)
Like positive information only (n = 17)
Like all available information and be involved in decisions (n = 129)
Explanation of illness Information on side effects Discussion of treatment options/clinical trials Discussion of lifestyle issues Discussion of practical issues Overall information provided
3.48 3.23 3.38 2.95 2.95 3.27
3.33 3.24 3.12 2.82 2.59 3.12
3.17 3.33 2.83* 2.50* 3.17 3.33
Significant difference in mean scores (Chi-squared test p < 0.05).
Satisfaction scores The majority of patients were satisfied or very satisfied with the information they received on their illness, side effects, other treatment options, practical issues and overall information given. Fewer were satisfied/very satisfied with discussion of lifestyle issues. There was no significant difference in mean satisfaction scores between the two information groups using Chi-squared statistics (p > 0.05) as shown in Table 2. When the mean scores for individual questions were analyzed according to the patients’ information needs (Table 3), the group of patients who wanted only limited information and preferred the doctor to make treatment decisions were significantly less satisfied with the information they received on other treatment options and lifestyle issues (Chi-squared statistics, p < 0.05).There was no significant difference in either information arms in this small group of patients (n = 6) who wanted only limited information. The mean total satisfaction score for the patients who received the standard consultation was 19.03 with a standard deviation (SD) of 3.14. For the patients who received the intensive information, their mean total score was 18.78 with a SD of 3.92. There was no statistically significant difference between these total scores (p > 0.05).The recommendation for scores of 15–19 is that minor fine tuning is required only.
Discussion Our population was generally very satisfied with the information they received prior to embarking on a course of radiation therapy. The addition of more intensive information, in both the written and verbal forms, did not reduce anxiety in our population. It is likely that patients source the information that they individually require from a number of different sources and therefore can supplement the information they are given in the clinic by other sources such as the internet and cancer support groups. This is most likely the reason why intensifying the information given also did not improve patient satisfaction. Hahn et al., 2005 [11] assessed the information needs of radiation oncology patients using a self-administered 5 question questionnaire concerning specific informational needs. Subjects were asked to rate the importance of information on potential side effects, side effects to report to their doctor or nurse, prevention of side effects, what will happen during radiation therapy and how they will feel during radiation therapy. No question addressed the need for information on lifestyle issues and alternative therapies. In our earlier pilot study [7], we found that the information on side effects and what will happen during radiation therapy was well addressed but patients wanted and needed more information on lifestyle and practical issues. Even after addressing this deficit in this study, patients still felt less satisfied with the information on lifestyle issues.
The medium in which this information is conveyed to the patient may be a factor in their satisfaction. The use of a patient education video in addition to standard written educational materials produced high levels of satisfaction as reported by Hahn et al. [11]. Perhaps combining information conveying mediums can lead to greater patient satisfaction however very few studies have really addressed the need for adding information regarding lifestyle issues. Other means of conveying information published include the use of an orientation programme. Adding an orientation programme to the standard verbal and written information given to new radiation oncology patients did not have a significant effect on state anxiety, general distress, objectively measured treatment adherence, the use of most ancillary services and the knowledge about radiation therapy for patients or family members [12]. Satisfaction with care in patients assigned to receive the orientation programme was slightly higher however the satisfaction was high in both groups similar to our findings. The orientation programme did however increase the use of psychological counselling services and of outside support services. There is little information in the literature regarding the importance of lifestyle issues to patients. Siekkinen et al., 2008 [13], found that patients attending outpatient radiotherapy in a university hospital in Finland rated the information received on alternative treatments low. High ratings were given to professionalism in nursing, talking with patients and written information. Once again, it appears that centres worldwide are finding that information on lifestyle issues such as alternative therapies, diet and exercise is not being adequately conveyed to patients [7,13]. This may partly be due to the physicians and nurses not having the confidence to discuss up to date findings in these areas. Considerable work has been done assessing cancer patients’ unmet needs regarding supportive care during the diagnostic, treatment and follow-up phases of the cancer journey [14,15,17]. These are the needs that are deemed important and unsatisfied by patients [16]. Supportive care includes the provision of services to meet physical, psychological, social, information and spiritual needs. Psychosocial supports, spiritual and a number of tools have been developed to assess these unmet needs. In this project, we focused primarily on the information needs of patients about to embark on a course of curative radiation therapy. We found that there is a need for more or better information on lifestyle issues. It is more likely that the need for information regarding lifestyle issues increases at the end of radiotherapy. Once a patient has completed their radiotherapy, they are often at the end of their cancer therapy and will be discharged to a follow-up programme. It is then that they often specifically ask about what active measures they can take to reduce the risk of cancer recurrence. This is the time where lifestyle issues, particularly for breast and bowel cancer, are of paramount importance. More research needs to be done to address the issue
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of the impact of discussion of lifestyle factors such as diet, exercise and alternative therapies. This appears to be an area of need and one which may lead to an improvement in the quality of cancer care if addressed adequately. Acknowledgements The authors want to express their gratitude to research assistants, Louise Tusak and Katie Harper, for their help with the distribution of questionnaires. They also thank Ms. Andrea Provis, for her contribution in the conception of this study. This work was partially supported by a research grant from the Royal Australian and New Zealand College of Radiologists.
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