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The quality of Life of early breast cancer patients treated by two different radiotherapy regimens
Clinical Oncology (1993) 5:228-233 © 1993 The Royal College of Radiologists
Clinical Oncology
Original Article The Quality of Life of Early Breast Cancer Patients Treated by Two Different Radiotherapy Regimens L. M. Wallace 1, S. G. Priestman 2, J. A. Dunn 3 and T. J. Priestman 2 ~South Birmingham District Psychology Service, 2Department of Radiotherapy, Queen Elizabeth Hospital, Birmingham and 3West Midlands Cancer Research Campaign Clinical Trials Unit, Birmingham, UK
Abstract. A cohort of 63 patients participating in a prospectively randomized trial evaluating two different radiotherapy regimens and adjuvant tamoxifen in the conservative management of early breast cancer were monitored by a series of psychological measures. The aim was to determine whether there was any difference between the radiotherapy schedules in terms of their impact on the patient's quality of life and whether measures of coping style and trait anxiety could be used to predict the subjective response to treatment. Overall, radiotherapy had little effect on quality of life and the differences between the two regimens were minor with significantly more of those women on the longer treatment schedule experiencing a transient weight change, disruption of private life and loss of positivity compared with those on the shorter schedule. In anticipating psychological adjustment to treatment, coping style proved unhelpful but trait anxiety was found to be a robust indicator of response, suggesting that it may be possible to determine in advance those patients who are likely to exhibit psychological distress during radiotherapy.
Keywords: Breast cancer; Quality of life; Radiotherapy
INTRODUCTION This study was initiated as an adjunct to a West Midlands Oncology Association (WMOA) trial evaluating two different radiotherapy regimens and adjuvant tamoxifen in the conservative management of early breast cancer. The aims of the study were two-fold: first, to determine whether there was any difference between the two radiotherapy schedules in terms of their impact on quality of life and patients' overall rating of the worthwhileness of treatment, and secondly, to determine whether psychological measures of coping style and trait anxiety could be Correspondence and offprint requests to: Dr T. J. Priestman, Royal Hospital, Wolverhampton WV2 1BT, UK.
used to predict which patients would have the greatest deterioration in their quality of life as a result of treatment.
PATIENTS AND METHODS Women in the W M O A trial who attended the Queen Elizabeth Hospital, Birmingham, for postoperative irradiation following lumpectomy for carcinoma of the breast were asked to participate in the study. Those who agreed were first interviewed when they attended for pretreatment planning. By this time they had been randomized to receive one of two radiotherapy regimens: either 40 Gy in 15 daily fractions or 50 Gy in 25 daily fractions, both with a supplementary boost to the local tumour site of a direct 10-14 MeV electron field of 15 Gy in 5 fractions, resulting in either a 4-week (short) or 6week (long) treatment schedule. For the initial phase, treatment was delivered by 6°Co isocentric megavoltage apparatus using a four-field technique to irradiate the breast and ipsilateral axillary, supraclavicular and first station internal mammary lymph nodes. All patients were taking tamoxifen at a dose of 20 mg daily. During the pretreatment interview the incidence and severity of symptoms were measured on the symptom distress scale, adapted from Nerenz et al. [1]. This included 13 possible symptoms, and patients were also given the opportunity to record any additional problems they were experiencing. Their current mood was measured using the hospital anxiety depression scale (HADS), developed by Zigmund and Snaith [2] and their global quality of life was scored using the instrument developed by Spitzer et al. [3]. The latter looked at five parameters: activity, daily aid from others, wellness, family support and outlook. The psychological prediction of adjustment to treatment was assessed with the health opinion survey [4], which assesses whether patients prefer to take active or passive roles in their treatment, by documenting their attitudes (HOSI index) and recording their behaviour (HOSB index). The
229
Quality of Life of Early Breast Cancer Patients
Spielberger trait anxiety inventory (STAI) was used to assess the general personality trait of anxiety proneness, which has been shown to predict which patients will react to physical threat with increased anxiety and distress [5]. Patients were next interviewed within 7 days of the completion of irradiation. At this time they completed the HADS scale, the symptom distress scale and the global quality of life measure. In addition two new instruments were introduced: first, the treatment disruption scale [6], a questionnaire intended to measure the effect of treatment on aspects of patients' lives and their feelings about the effects of treatment, and secondly, a measure of patients' views on the worthwhileness of treatment. This latter instrument was designed specifically for this study and is shown in Appendix 1. Two formats of this scale were developed (one linear and one categorical) with the intention of assessing the amount of reassurance received from radiotherapy staff, the perceived effect of radiotherapy on health, the effect of treatment on private life and patients' overall opinions on the value of therapy. The HADS scale, the global quality of life measure and the worthwhileness measure were repeated at 6 months after completion of radiotherapy. The data were stored on a dual VAX 3600 system and analysed using the BMDP statistical package [7]. Exploratory analysis of the continuous variables showed that the data did not follow a normal distribution and therefore Mann-Whitney tests were carried out to test for differences between the two treatment arms. Contingency tables for the categorical data were analysed using the Pearson Chi-square statistic to show any significant associations between variables. McNemar's test and the BMDP2V program were used to detect any change over time for the categorical and continuous data, respectively. In order to detect any correlation or multicolinearity between the variables the correlation matrix was examined.
RESULTS Sixty-three patients entered the study, 31 had been randomized to the short course of radiotherapy (group S) and 32 to the long course (group L). All
patients completed pre- and post-treatment questionnaires but 27 were lost at the 6-month follow-up.
Comparison of Randomized Groups Before Treatment The mean age of women in group S was 55.0 years compared with 53.6 years for those in group L (Mann-Whitney = 458, P -- 0.72). Pretreatment anxiety, depression, trait anxiety and health opinion are shown in Table 1; only the HOSI measure showed a significant different between the two groups. Eleven patients registered cIinically significant levels of anxiety as measured on the HADS scale (with scores >10) at the onset of irradiation. One of these patients required psychiatric intervention and had a past history of similar problems, but the remaining ten completed their irradiation without psychiatric referral, eight women showing a reduction in anxiety and two showing no change. Depression levels, as measured by the HADS scale, were low in both groups with only 8% of patients overall registering scores >10. Only one patient remained depressed at the end of treatment, this was the patient who received psychiatric intervention. The global quality of life measure demonstrated that most patients were fit and fairly active prior to their irradiation, with the majority doing their own housework or continuing in employment and leading a normal life. The question on how the patient had been feeling during the previous week produced more variation in replies, with 32% of group S and 41% of group L reporting feeling 'not up to par'. Similarly the outlook of the patients during the previous week varied with 26% of group S and 44% of group L feeling troubled by anxiety and less positive in their outlook. However, these differences were not statistically significant. The scores on the health opinion survey were significantly different for the information component (HOSI) of the questionnaire (Mann-Whitney = 650, P = 0.03) though not for the behaviour assessment (HOSB). Trait anxiety, as measured by the STAI was also similar for both groups and was within normal limits. In response to the symptom distress scale, six symptoms were recorded by >10% of the patients, although not all were distressed by their presence
Table 1. Mean values, standard errors and confidence intervals of psychological measures prior to radiotherapy
Measure
HADS anxiety HADS depression STAI trait anxiety HOS information HOS behaviour
Group S (n=31)
Group L (n=32)
P value a
Mean
SE
Confidence interval
Mean
SE
Confidence interval
6.2 3.7 34.1 2.8 3.1
0.82 0.74 1.95 0.38 0.45
7.%4.5 5.2-2.2 38.1-30.1 3.6-2.0 4.0-2.2
6.7 3.8 35.0 1.7 3.0
0.72 0.62 1.5 0.37 0.35
8.2-5.2 5.1-2.5 38.1-31.9 2.5-0.9 3.7--2.3
aMann-Whitney non-parametric test
0.39 0.69 0.36 0.03 0.91
L. M. Wallace et al.
230 Table 2. Symptoms prior to irradiation
Symptom
Pain Tiredness Depression Weight loss Insomnia
Treatment (S: n=31, L: n=32)
S L S L S L S L S L
Impact of symptom (%)
Incidence (%)
26 31 22 34 19 47 29 28 32 19
(Table 2). The only significant difference between the groups related to depression, which was commoner in group L (47% versus 19%, P = 0.03) and also caused distress in a higher proportion of patients in that group (41% versus 13%, P = 0.01).
Comparison of Randomized Groups After Radiotherapy On completion of treatment there was an overall reduction in anxiety levels (P = 0.001), but this was not significantly different between the two groups (P -- 0.28). Depression levels remained relatively constant (Table 3). Only five patients had clinically significant levels of anxiety (scores >10) post-treatment and only four patients had significant levels at 6 months. Two patients were clinically depressed (HADs score >10) post-treatment and one at 6 months. Of the six parameters covered by the global quality of life scale, two showed significant differences. On scores of 'wellness', approximately one-third of patients in group S felt 'not up to par' before treatment (11/31), post-treatment (13/31) and at 6 months (4/17). In comparison, about half the women in group L reported similar feelings (15/32), (15,/32) and (4/19), respectively; this latter difference was significant (P = 0.02). Before treatment 23/31 (74%) in group S and 19/32 (56%) in group L reported a positive outlook on their future health, at the posttreatment assessment the figures were 23/31 (74%) and 16/32 (50%) respectively, the latter figures representing a significant (P <0.05 difference between the
None/mild
Moderate
Severe
84 88 88 78 87 59 93 100 84 87
16 12 6 19 10 32 6 0 13 13
0 0 6 3 3 9 0 0 3 0
two groups. At 6 months the figures were 13/17 (76%) for group S and 12/19 (63%) for group L which were not significantly different. The symptom distress scale showed a significant increase in scores for four parameters on completion of radiotherapy, these were nausea (P = 0.012), tiredness (P <0.001), sleep disturbance (P = 0.02) and skin irritation (P <0.0001). There was also a significant difference between the two arms of the study with a greater incidence of weight change (P = 0.01) in group L. Despite these differences the results of the treatment disruption scale showed a minimal impact of radiotherapy on patients' daily lives, with a comparison of the impact of the emotional and behavioural impact of treatment on family and sexual relationships, finances, work and general activities showing no significant differences between the groups. Twenty-seven patients responded anonymously to the worthwhileness measure immediately after treatment and 23 replied at 6 months. The categorical and linear scales were highly correlated (r = 0.9) although patient preference was generally for the categorical format. There were no differences between the treatment arms in the period immediately after treatment, but at 6 months those in group L reported greater disruption of their personal life. Although the differences were not significant, worthwhileness ratings for both groups tended to be more negative at 6 months than at the end of treatment. For example, 4/27 (15%) did not feel reassured by staff and 4/25 (16%) did not feel radiotherapy was worthwhile at the end of treatment compared with 47% and 29% respectively at 6 months.
Table 3. Mean scores (standard errors) for mood states before and after treatment
HADS scale
Time in relations to radiotherapy (RT) Before
Anxiety Depression
1 week post-RT
6 months post-RT
S (SE) (n=31)
L (SE) (n= 32)
pa
S (SE) (n=31)
L (SE) (n=32)
pa
S (SE) (n=17
L (SE) (n=19)
pa
6.2 (0.82) 3.7 (0.75)
6.7 (0.72) 3.8 (0.62)
0.39 0.69
3.8 (0.59) 3.9 (0.64)
5.2 (0.63) 3.4 (0.52)
0.13 0.77
3.0 (0.56) 2.8 (0.65)
5.3 (1.04) 3.2 (1.00)
0.2 0.96
"Mann-Whitney non-parametric test
Quality of Life of Early Breast Cancer Patients
Psychological Predictors of Response to Radiotherapy Factor analysis revealed that trait anxiety scores before treatment predicted psychological reactions before and after radiotherapy. There was moderate correlation of greater symptom reporting with high trait anxiety scores for tiredness (r = 0.49, P <0.01), depression (r = 0.5, P <0.01) and sleep loss (r = 0.41, P <0.05). There was also a correlation between high trait anxiety and greater scores on the treatment disruption scale with respect to emotional impact (r = 0.44, P <0.05) and with a reduction in the global quality of life total (r = 0.5, P <0.01). The coping style measure, reflecting an active or passive orientation to treatment, proved to be an independent factor and did not correlate with measures of treatment adjustment.
DISCUSSION The overall impact of radiotherapy was less dramatic than might have been expected. The levels of psychological distress before treatment were 17.5% for anxiety and 8% for depression compared with 6% and 8%, respectively, on completion of irradiation; overall, the measures of psychological disturbance were within the normal range by the end of radiotherapy. The incidence of nausea, tiredness, sleep disturbance and skin irritation increased during radiotherapy but these caused little disruption to daily living and there was little impact on the global measure of quality of life. There was, however, a slight decline in the overall positivity of outlook and less confidence in the impact of treatment on health following the completion of treatment. The objective worthwhileness of adjuvant treatment cannot be determined immediately but patients felt able to rate the subjective value of treatment in terms of the impact of radiotherapy on their general health and quality of life; 16% of patients on completion of treatment and 26% at 6 months felt irradiation had not been worthwhile. There were no obvious differences in these patients' physical or psychological responses to treatment to explain this. Clearer explanation of the rationale of adjuvant therapy might reduce possible unrealistic expectations of an immediate health gain. It is therefore suggested that further studies with worthwhileness measures use categorical rating scales, which appear
231
to be preferred by the patient, but allow space for comments so that individuals may elaborate on the reasons for their judgements on the value of treatment. The differential impact of the two radiotherapy regimens on patients' subjective responses was less than might be expected. Those undergoing the longer treatment showed greater weight change, higher scores for disruption of private life and a less positive outlook on completion of treatment, but none of these parameters was still significant at 6 months. At the later assessment, however, those who had undergone the longer treatment showed greater anxiety and a greater feeling of being 'not up to par' but the extent to which these factors may be attributed to the difference in radiotherapy schedules is doubtful, especially as this group had shown a greater incidence and severity of depression prior to commencing irradiation. The high rate of drop-out at follow-up (27/63) also detracts from any categorical conclusions being drawn. In predicting the psychological adjustment to treatment the coping style measure proved unhelpful. Trait anxiety, however, proved to be a robust measure of states of anxiety and depression associated with treatment. This suggests that it is possible to screen out patients by using the trait anxiety scale, which is a simple paper and pencil test, immediately prior to treatment to determine those who are likely to show psychological distress during radiotherapy. Similarly the HADS test administered during treatment might be used to detect those who may benefit from extra reassurance and/or referral for psychiatric support.
References 1. Nerenz DR, Leventhal H, Love RR. Factors contributing to emotional distress during cancer chemotherapy. Cancer 1982;50:1020-7. 2. Zigmund AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361-70. 3. Spitzer WO, Dobson AJ, Hall J. Measuring the quality of life of cancer patients. J Chronic Dis 1981;34:585-98. 4. Krantz DS, Baum A, Widemean MV. Assessment of preferences for self-treatment and information in health care. J Per Soc Psychol 1980;39:977-90. 5. Spielberger CD, Gorsuch RL, Lushene R. The state-trait anxiety inventory. Palo Alto, California: Consulting Psychology Press, 1969. 6. Meyerowitz BE, Sparks FC, Spears IK. Adjuvant chemotherapy for breast carcinoma: Psychosocial implications. Cancer 1979;43:1613-8. 7. Dixon W, Brown M, Engelman L. BMDP statistical software manual. Berkeley: University of California, 1988.
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L . M . Wallace et al.
APPENDIX 1 Categorical RADIOTHERAPY OPINION FORM You have recently completed a course of radiotherapy for your breast disease. The doctors who treated you would like to know your opinion about this treatment. Would you therefore fill in this form and return it in the envelope provided? Please be as frank as you like - your reply will be treated confidentially. There are no right or wrong answers to the questions, just try to express your true opinion. If you don't want to answer any questions, leave them blank and return the form - we won't mind! We are mainly interested in your opinion about the radiotherapy part of your treatment given to you between and at Hospital. If you have any comments about other parts of your treatment, for example surgery, please keep these for the space at the very end of the form. To record your opinions please tick the box which best describes your feelings about each issue. If you want to say more, please write in the 'comments' sections. A
Please describe your contact with the staff and other patients at the radiotherapy department. [ ] Didn't have much contact, so can't say
B
[ ] Has made my health worse
[ ] Hasn't made any difference
[ ] Has reduced my chances of a healthy life
Describe the overall effect that radiotherapy has had on your private life. [ ] Has been of positive benefit
E
[ ] Hasn't made any difference
What difference do you think radiotherapy has made to your health in the long-term? [ ] Has improved my chances of a healthy life
D
[ ] Made me feel worried, more uneasy
Please describe the effect that radiotherapy has had on your health so far. [ ] Has improved my health
C
[ ] Made me feel reassured, more optimistic
[ ] Hasn't made any difference
[ ] Has been disruptive
Overall do you feel that the radiotherapy treatment was worth it? [ ] No, not at all
[ ] Only a little
[ ] Yes, definitely worth it
Any other comments about radiotherapy?
Any comments about other parts of your treatment?
Comments [ ] I have no strong feelings either way
Quality of Life of Early Breast Cancer Patients
233
Linear RADIOTHERAPY OPINION FORM You have recently completed a course of radiotherapy for your breast disease. The doctors who treated you would like to know your opinion about the treatment. Would you therefore please fill in this form and return it in the envelope provided? Please be as frank as you like - your reply will be treated confidentially. There are no right or wrong answers to the questions, just try to express your true opinion. If you don't want to answer any questions, leave the form blank and return it in the envelope - we won't mind! We are interested in the radiotherapy part of your treatment given to you between and at the Queen Elizabeth Hospital. If you have any comments about other parts of your treatment, please keep those for the space at the very end of the form. To record your opinions please mark along the line how certain you feel about each statement. For example, a mark on the line about halfway shows you feel only 50% certain that this treatment has improved your health: Example: DO YOU FEEL THAT YOUR RADIOTHERAPY HAS IMPROVED YOUR HEALTH? Not at all Improved my Health 1.
0
X
Definitely 100 Improved my Health
Did you feel reassured by your contact with the staff and patients of the radiotherapy department?
Not at all reassured
0
2. Do you feel the radiotherapy has improved your health? Not at all improved 0 my health
100
Comments
Completely reassured
Definitely 100 improved my health
3. Do you feel the radiotherapy has had a disruptive effect on your private life? Has been Has made no completely difference disruptive of 0 100 to my private my private life life 4.
Overall, do you feel that the radiotherapy treatment was worth it for you?
Not at all worth it
0
100
Completely worth it
5.
If you had your time over again, how likely is it you would accept radiotherapy? Not at all Definitely likely I would 0 100 would accept accept Any other comments about your radiotherapy
Any comments about other parts of your treatment?
Received for publication November 1989 Accepted following revision June 1993
Clinical Oncology
Original Article The Quality of Life of Early Breast Cancer Patients Treated by Two Different Radiotherapy Regimens L. M. Wallace 1, S. G. Priestman 2, J. A. Dunn 3 and T. J. Priestman 2 ~South Birmingham District Psychology Service, 2Department of Radiotherapy, Queen Elizabeth Hospital, Birmingham and 3West Midlands Cancer Research Campaign Clinical Trials Unit, Birmingham, UK
Abstract. A cohort of 63 patients participating in a prospectively randomized trial evaluating two different radiotherapy regimens and adjuvant tamoxifen in the conservative management of early breast cancer were monitored by a series of psychological measures. The aim was to determine whether there was any difference between the radiotherapy schedules in terms of their impact on the patient's quality of life and whether measures of coping style and trait anxiety could be used to predict the subjective response to treatment. Overall, radiotherapy had little effect on quality of life and the differences between the two regimens were minor with significantly more of those women on the longer treatment schedule experiencing a transient weight change, disruption of private life and loss of positivity compared with those on the shorter schedule. In anticipating psychological adjustment to treatment, coping style proved unhelpful but trait anxiety was found to be a robust indicator of response, suggesting that it may be possible to determine in advance those patients who are likely to exhibit psychological distress during radiotherapy.
Keywords: Breast cancer; Quality of life; Radiotherapy
INTRODUCTION This study was initiated as an adjunct to a West Midlands Oncology Association (WMOA) trial evaluating two different radiotherapy regimens and adjuvant tamoxifen in the conservative management of early breast cancer. The aims of the study were two-fold: first, to determine whether there was any difference between the two radiotherapy schedules in terms of their impact on quality of life and patients' overall rating of the worthwhileness of treatment, and secondly, to determine whether psychological measures of coping style and trait anxiety could be Correspondence and offprint requests to: Dr T. J. Priestman, Royal Hospital, Wolverhampton WV2 1BT, UK.
used to predict which patients would have the greatest deterioration in their quality of life as a result of treatment.
PATIENTS AND METHODS Women in the W M O A trial who attended the Queen Elizabeth Hospital, Birmingham, for postoperative irradiation following lumpectomy for carcinoma of the breast were asked to participate in the study. Those who agreed were first interviewed when they attended for pretreatment planning. By this time they had been randomized to receive one of two radiotherapy regimens: either 40 Gy in 15 daily fractions or 50 Gy in 25 daily fractions, both with a supplementary boost to the local tumour site of a direct 10-14 MeV electron field of 15 Gy in 5 fractions, resulting in either a 4-week (short) or 6week (long) treatment schedule. For the initial phase, treatment was delivered by 6°Co isocentric megavoltage apparatus using a four-field technique to irradiate the breast and ipsilateral axillary, supraclavicular and first station internal mammary lymph nodes. All patients were taking tamoxifen at a dose of 20 mg daily. During the pretreatment interview the incidence and severity of symptoms were measured on the symptom distress scale, adapted from Nerenz et al. [1]. This included 13 possible symptoms, and patients were also given the opportunity to record any additional problems they were experiencing. Their current mood was measured using the hospital anxiety depression scale (HADS), developed by Zigmund and Snaith [2] and their global quality of life was scored using the instrument developed by Spitzer et al. [3]. The latter looked at five parameters: activity, daily aid from others, wellness, family support and outlook. The psychological prediction of adjustment to treatment was assessed with the health opinion survey [4], which assesses whether patients prefer to take active or passive roles in their treatment, by documenting their attitudes (HOSI index) and recording their behaviour (HOSB index). The
229
Quality of Life of Early Breast Cancer Patients
Spielberger trait anxiety inventory (STAI) was used to assess the general personality trait of anxiety proneness, which has been shown to predict which patients will react to physical threat with increased anxiety and distress [5]. Patients were next interviewed within 7 days of the completion of irradiation. At this time they completed the HADS scale, the symptom distress scale and the global quality of life measure. In addition two new instruments were introduced: first, the treatment disruption scale [6], a questionnaire intended to measure the effect of treatment on aspects of patients' lives and their feelings about the effects of treatment, and secondly, a measure of patients' views on the worthwhileness of treatment. This latter instrument was designed specifically for this study and is shown in Appendix 1. Two formats of this scale were developed (one linear and one categorical) with the intention of assessing the amount of reassurance received from radiotherapy staff, the perceived effect of radiotherapy on health, the effect of treatment on private life and patients' overall opinions on the value of therapy. The HADS scale, the global quality of life measure and the worthwhileness measure were repeated at 6 months after completion of radiotherapy. The data were stored on a dual VAX 3600 system and analysed using the BMDP statistical package [7]. Exploratory analysis of the continuous variables showed that the data did not follow a normal distribution and therefore Mann-Whitney tests were carried out to test for differences between the two treatment arms. Contingency tables for the categorical data were analysed using the Pearson Chi-square statistic to show any significant associations between variables. McNemar's test and the BMDP2V program were used to detect any change over time for the categorical and continuous data, respectively. In order to detect any correlation or multicolinearity between the variables the correlation matrix was examined.
RESULTS Sixty-three patients entered the study, 31 had been randomized to the short course of radiotherapy (group S) and 32 to the long course (group L). All
patients completed pre- and post-treatment questionnaires but 27 were lost at the 6-month follow-up.
Comparison of Randomized Groups Before Treatment The mean age of women in group S was 55.0 years compared with 53.6 years for those in group L (Mann-Whitney = 458, P -- 0.72). Pretreatment anxiety, depression, trait anxiety and health opinion are shown in Table 1; only the HOSI measure showed a significant different between the two groups. Eleven patients registered cIinically significant levels of anxiety as measured on the HADS scale (with scores >10) at the onset of irradiation. One of these patients required psychiatric intervention and had a past history of similar problems, but the remaining ten completed their irradiation without psychiatric referral, eight women showing a reduction in anxiety and two showing no change. Depression levels, as measured by the HADS scale, were low in both groups with only 8% of patients overall registering scores >10. Only one patient remained depressed at the end of treatment, this was the patient who received psychiatric intervention. The global quality of life measure demonstrated that most patients were fit and fairly active prior to their irradiation, with the majority doing their own housework or continuing in employment and leading a normal life. The question on how the patient had been feeling during the previous week produced more variation in replies, with 32% of group S and 41% of group L reporting feeling 'not up to par'. Similarly the outlook of the patients during the previous week varied with 26% of group S and 44% of group L feeling troubled by anxiety and less positive in their outlook. However, these differences were not statistically significant. The scores on the health opinion survey were significantly different for the information component (HOSI) of the questionnaire (Mann-Whitney = 650, P = 0.03) though not for the behaviour assessment (HOSB). Trait anxiety, as measured by the STAI was also similar for both groups and was within normal limits. In response to the symptom distress scale, six symptoms were recorded by >10% of the patients, although not all were distressed by their presence
Table 1. Mean values, standard errors and confidence intervals of psychological measures prior to radiotherapy
Measure
HADS anxiety HADS depression STAI trait anxiety HOS information HOS behaviour
Group S (n=31)
Group L (n=32)
P value a
Mean
SE
Confidence interval
Mean
SE
Confidence interval
6.2 3.7 34.1 2.8 3.1
0.82 0.74 1.95 0.38 0.45
7.%4.5 5.2-2.2 38.1-30.1 3.6-2.0 4.0-2.2
6.7 3.8 35.0 1.7 3.0
0.72 0.62 1.5 0.37 0.35
8.2-5.2 5.1-2.5 38.1-31.9 2.5-0.9 3.7--2.3
aMann-Whitney non-parametric test
0.39 0.69 0.36 0.03 0.91
L. M. Wallace et al.
230 Table 2. Symptoms prior to irradiation
Symptom
Pain Tiredness Depression Weight loss Insomnia
Treatment (S: n=31, L: n=32)
S L S L S L S L S L
Impact of symptom (%)
Incidence (%)
26 31 22 34 19 47 29 28 32 19
(Table 2). The only significant difference between the groups related to depression, which was commoner in group L (47% versus 19%, P = 0.03) and also caused distress in a higher proportion of patients in that group (41% versus 13%, P = 0.01).
Comparison of Randomized Groups After Radiotherapy On completion of treatment there was an overall reduction in anxiety levels (P = 0.001), but this was not significantly different between the two groups (P -- 0.28). Depression levels remained relatively constant (Table 3). Only five patients had clinically significant levels of anxiety (scores >10) post-treatment and only four patients had significant levels at 6 months. Two patients were clinically depressed (HADs score >10) post-treatment and one at 6 months. Of the six parameters covered by the global quality of life scale, two showed significant differences. On scores of 'wellness', approximately one-third of patients in group S felt 'not up to par' before treatment (11/31), post-treatment (13/31) and at 6 months (4/17). In comparison, about half the women in group L reported similar feelings (15/32), (15,/32) and (4/19), respectively; this latter difference was significant (P = 0.02). Before treatment 23/31 (74%) in group S and 19/32 (56%) in group L reported a positive outlook on their future health, at the posttreatment assessment the figures were 23/31 (74%) and 16/32 (50%) respectively, the latter figures representing a significant (P <0.05 difference between the
None/mild
Moderate
Severe
84 88 88 78 87 59 93 100 84 87
16 12 6 19 10 32 6 0 13 13
0 0 6 3 3 9 0 0 3 0
two groups. At 6 months the figures were 13/17 (76%) for group S and 12/19 (63%) for group L which were not significantly different. The symptom distress scale showed a significant increase in scores for four parameters on completion of radiotherapy, these were nausea (P = 0.012), tiredness (P <0.001), sleep disturbance (P = 0.02) and skin irritation (P <0.0001). There was also a significant difference between the two arms of the study with a greater incidence of weight change (P = 0.01) in group L. Despite these differences the results of the treatment disruption scale showed a minimal impact of radiotherapy on patients' daily lives, with a comparison of the impact of the emotional and behavioural impact of treatment on family and sexual relationships, finances, work and general activities showing no significant differences between the groups. Twenty-seven patients responded anonymously to the worthwhileness measure immediately after treatment and 23 replied at 6 months. The categorical and linear scales were highly correlated (r = 0.9) although patient preference was generally for the categorical format. There were no differences between the treatment arms in the period immediately after treatment, but at 6 months those in group L reported greater disruption of their personal life. Although the differences were not significant, worthwhileness ratings for both groups tended to be more negative at 6 months than at the end of treatment. For example, 4/27 (15%) did not feel reassured by staff and 4/25 (16%) did not feel radiotherapy was worthwhile at the end of treatment compared with 47% and 29% respectively at 6 months.
Table 3. Mean scores (standard errors) for mood states before and after treatment
HADS scale
Time in relations to radiotherapy (RT) Before
Anxiety Depression
1 week post-RT
6 months post-RT
S (SE) (n=31)
L (SE) (n= 32)
pa
S (SE) (n=31)
L (SE) (n=32)
pa
S (SE) (n=17
L (SE) (n=19)
pa
6.2 (0.82) 3.7 (0.75)
6.7 (0.72) 3.8 (0.62)
0.39 0.69
3.8 (0.59) 3.9 (0.64)
5.2 (0.63) 3.4 (0.52)
0.13 0.77
3.0 (0.56) 2.8 (0.65)
5.3 (1.04) 3.2 (1.00)
0.2 0.96
"Mann-Whitney non-parametric test
Quality of Life of Early Breast Cancer Patients
Psychological Predictors of Response to Radiotherapy Factor analysis revealed that trait anxiety scores before treatment predicted psychological reactions before and after radiotherapy. There was moderate correlation of greater symptom reporting with high trait anxiety scores for tiredness (r = 0.49, P <0.01), depression (r = 0.5, P <0.01) and sleep loss (r = 0.41, P <0.05). There was also a correlation between high trait anxiety and greater scores on the treatment disruption scale with respect to emotional impact (r = 0.44, P <0.05) and with a reduction in the global quality of life total (r = 0.5, P <0.01). The coping style measure, reflecting an active or passive orientation to treatment, proved to be an independent factor and did not correlate with measures of treatment adjustment.
DISCUSSION The overall impact of radiotherapy was less dramatic than might have been expected. The levels of psychological distress before treatment were 17.5% for anxiety and 8% for depression compared with 6% and 8%, respectively, on completion of irradiation; overall, the measures of psychological disturbance were within the normal range by the end of radiotherapy. The incidence of nausea, tiredness, sleep disturbance and skin irritation increased during radiotherapy but these caused little disruption to daily living and there was little impact on the global measure of quality of life. There was, however, a slight decline in the overall positivity of outlook and less confidence in the impact of treatment on health following the completion of treatment. The objective worthwhileness of adjuvant treatment cannot be determined immediately but patients felt able to rate the subjective value of treatment in terms of the impact of radiotherapy on their general health and quality of life; 16% of patients on completion of treatment and 26% at 6 months felt irradiation had not been worthwhile. There were no obvious differences in these patients' physical or psychological responses to treatment to explain this. Clearer explanation of the rationale of adjuvant therapy might reduce possible unrealistic expectations of an immediate health gain. It is therefore suggested that further studies with worthwhileness measures use categorical rating scales, which appear
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to be preferred by the patient, but allow space for comments so that individuals may elaborate on the reasons for their judgements on the value of treatment. The differential impact of the two radiotherapy regimens on patients' subjective responses was less than might be expected. Those undergoing the longer treatment showed greater weight change, higher scores for disruption of private life and a less positive outlook on completion of treatment, but none of these parameters was still significant at 6 months. At the later assessment, however, those who had undergone the longer treatment showed greater anxiety and a greater feeling of being 'not up to par' but the extent to which these factors may be attributed to the difference in radiotherapy schedules is doubtful, especially as this group had shown a greater incidence and severity of depression prior to commencing irradiation. The high rate of drop-out at follow-up (27/63) also detracts from any categorical conclusions being drawn. In predicting the psychological adjustment to treatment the coping style measure proved unhelpful. Trait anxiety, however, proved to be a robust measure of states of anxiety and depression associated with treatment. This suggests that it is possible to screen out patients by using the trait anxiety scale, which is a simple paper and pencil test, immediately prior to treatment to determine those who are likely to show psychological distress during radiotherapy. Similarly the HADS test administered during treatment might be used to detect those who may benefit from extra reassurance and/or referral for psychiatric support.
References 1. Nerenz DR, Leventhal H, Love RR. Factors contributing to emotional distress during cancer chemotherapy. Cancer 1982;50:1020-7. 2. Zigmund AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983;67:361-70. 3. Spitzer WO, Dobson AJ, Hall J. Measuring the quality of life of cancer patients. J Chronic Dis 1981;34:585-98. 4. Krantz DS, Baum A, Widemean MV. Assessment of preferences for self-treatment and information in health care. J Per Soc Psychol 1980;39:977-90. 5. Spielberger CD, Gorsuch RL, Lushene R. The state-trait anxiety inventory. Palo Alto, California: Consulting Psychology Press, 1969. 6. Meyerowitz BE, Sparks FC, Spears IK. Adjuvant chemotherapy for breast carcinoma: Psychosocial implications. Cancer 1979;43:1613-8. 7. Dixon W, Brown M, Engelman L. BMDP statistical software manual. Berkeley: University of California, 1988.
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APPENDIX 1 Categorical RADIOTHERAPY OPINION FORM You have recently completed a course of radiotherapy for your breast disease. The doctors who treated you would like to know your opinion about this treatment. Would you therefore fill in this form and return it in the envelope provided? Please be as frank as you like - your reply will be treated confidentially. There are no right or wrong answers to the questions, just try to express your true opinion. If you don't want to answer any questions, leave them blank and return the form - we won't mind! We are mainly interested in your opinion about the radiotherapy part of your treatment given to you between and at Hospital. If you have any comments about other parts of your treatment, for example surgery, please keep these for the space at the very end of the form. To record your opinions please tick the box which best describes your feelings about each issue. If you want to say more, please write in the 'comments' sections. A
Please describe your contact with the staff and other patients at the radiotherapy department. [ ] Didn't have much contact, so can't say
B
[ ] Has made my health worse
[ ] Hasn't made any difference
[ ] Has reduced my chances of a healthy life
Describe the overall effect that radiotherapy has had on your private life. [ ] Has been of positive benefit
E
[ ] Hasn't made any difference
What difference do you think radiotherapy has made to your health in the long-term? [ ] Has improved my chances of a healthy life
D
[ ] Made me feel worried, more uneasy
Please describe the effect that radiotherapy has had on your health so far. [ ] Has improved my health
C
[ ] Made me feel reassured, more optimistic
[ ] Hasn't made any difference
[ ] Has been disruptive
Overall do you feel that the radiotherapy treatment was worth it? [ ] No, not at all
[ ] Only a little
[ ] Yes, definitely worth it
Any other comments about radiotherapy?
Any comments about other parts of your treatment?
Comments [ ] I have no strong feelings either way
Quality of Life of Early Breast Cancer Patients
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Linear RADIOTHERAPY OPINION FORM You have recently completed a course of radiotherapy for your breast disease. The doctors who treated you would like to know your opinion about the treatment. Would you therefore please fill in this form and return it in the envelope provided? Please be as frank as you like - your reply will be treated confidentially. There are no right or wrong answers to the questions, just try to express your true opinion. If you don't want to answer any questions, leave the form blank and return it in the envelope - we won't mind! We are interested in the radiotherapy part of your treatment given to you between and at the Queen Elizabeth Hospital. If you have any comments about other parts of your treatment, please keep those for the space at the very end of the form. To record your opinions please mark along the line how certain you feel about each statement. For example, a mark on the line about halfway shows you feel only 50% certain that this treatment has improved your health: Example: DO YOU FEEL THAT YOUR RADIOTHERAPY HAS IMPROVED YOUR HEALTH? Not at all Improved my Health 1.
0
X
Definitely 100 Improved my Health
Did you feel reassured by your contact with the staff and patients of the radiotherapy department?
Not at all reassured
0
2. Do you feel the radiotherapy has improved your health? Not at all improved 0 my health
100
Comments
Completely reassured
Definitely 100 improved my health
3. Do you feel the radiotherapy has had a disruptive effect on your private life? Has been Has made no completely difference disruptive of 0 100 to my private my private life life 4.
Overall, do you feel that the radiotherapy treatment was worth it for you?
Not at all worth it
0
100
Completely worth it
5.
If you had your time over again, how likely is it you would accept radiotherapy? Not at all Definitely likely I would 0 100 would accept accept Any other comments about your radiotherapy
Any comments about other parts of your treatment?
Received for publication November 1989 Accepted following revision June 1993