A psychosocial group intervention for Japanese women with primary breast carcinoma
A randomized controlled trial
Article first published online: 13 NOV 2000
Copyright © 2000 American Cancer Society
Volume 89, Issue 5, pages 1026–1036, 1 September 2000
How to Cite
Fukui, S., Kugaya, A., Okamura, H., Kamiya, M., Koike, M., Nakanishi, T., Imoto, S., Kanagawa, K. and Uchitomi, Y. (2000), A psychosocial group intervention for Japanese women with primary breast carcinoma. Cancer, 89: 1026–1036. doi: 10.1002/1097-0142(20000901)89:5<1026::AID-CNCR12>3.0.CO;2-5
- Issue published online: 13 NOV 2000
- Article first published online: 13 NOV 2000
- Manuscript Revised: 4 MAY 2000
- Manuscript Accepted: 4 MAY 2000
- Manuscript Received: 31 JAN 2000
- Japanese Ministry of Health and Welfare, Japan. Grant Number: 9-31
- Fumiko Yamaji Trust for Academic Nursing Education and Research, Tokyo, Japan
- psychosocial intervention;
- psychologic distress;
To the authors' knowledge, there had been no evidence for the efficacy of psychosocial intervention among Japanese cancer patients. The objective of this study was to determine the effect of a psychosocial group intervention in reducing psychologic distress and enhancing coping in this population in a randomized controlled trial.
The patient selection criteria were age younger than 65 years, lymph node metastasis positive and/or histologic or nuclear Grade 2–3, and surgery undergone within the previous 4–18 months as of the start of the study. We conducted a 6-week, structured, psychosocial group intervention. The intervention consisted of health education, coping skills training, stress management, and psychologic support. Subjects were assessed for psychologic distress and coping by administering the Profile of Mood States (POMS), Mental Adjustment to Cancer (MAC) scale, and Hospital Anxiety and Depression (HADS) scale at the baseline, at 6 weeks, and at 6 months.
Fifty (33%) of the 151 patients participated and were randomized, and 46 (30%) completed the study. The experimental group had significantly lower scores than the controls for total mood disturbance and significantly higher scores for vigor on the POMS, and significantly higher scores for fighting spirit on the MAC at the end of the 6-week intervention. These improvements were sustained over 6 months of follow-up.
The results of this study suggest that a short term psychosocial group intervention produces significant long term improvement in the quality of life of Japanese patients with primary breast carcinoma. Cancer 2000;89:1026–36. © 2000 American Cancer Society.
Approximately 30,000 new cases of breast carcinoma are diagnosed in Japan each year, making it the second most frequent type of cancer among women after gastric carcinoma.1, 2 In addition, there are 8600 deaths from breast carcinoma each year, and it is the fifth leading cause of cancer death.1 The annual incidence of breast carcinoma is expected to continue increasing until it reaches approximately 40,000 in 2015, thereafter remaining the second most common type of cancer.3 Psychosocial interventions to help patients with this cancer already have become an important means of assuring an adequate quality of life for them.
The high prevalence of psychosocial morbidity in breast carcinoma has been well documented in Western countries.4–9 Psychosocial intervention has been used to reduce the morbidity of breast carcinoma patients, and its effects have been evaluated over the past 2 decades.10–17 A meta-analysis in this area concluded that psychosocial intervention improves the quality of life of cancer patients,18 and several reviews have supported this conclusion.19–22
Nevertheless, to our knowledge, the effect of psychosocial intervention has never been assessed in a randomized controlled trial in Japan (MEDLINE 1966–99 and Cumulative Index to Nursing and Allied Health Literature 1966–99). One study has questioned whether the psychosocial intervention developed for European Americans would have the same efficacy in other cultural groups,23 and thus its effects need to be examined among Japanese cancer patients.
Several studies have indicated that a major concern of patients with primary breast carcinoma is fear of recurrence,24–27 and this situation probably would be true among individuals identified as being at higher risk of recurrence and informed of this likelihood. Despite this, to our knowledge, there has never been a study of psychologic intervention targeting such patients. Accordingly, it was considered appropriate to conduct a psychosocial intervention for patients at higher risk of recurrence with the objective of helping them to cope better with the fear of recurrence and preventing psychologic morbidity after recurrence.
The purpose of the current study was to examine the effects of psychosocial group intervention on psychologic distress and coping among Japanese women with primary breast carcinoma.
The subjects were selected from breast carcinoma outpatients who had been treated surgically at the National Cancer Center Hospital East, Japan, between August 1996 and February 1998. The study protocol was reviewed and approved by the Institutional Review Board and the Ethics Committee of the National Cancer Center, Japan.
Eligibility criteria for the current study were: 1) age younger than 65 years; 2) identified and informed of being at higher risk of recurrence (defined as having axillary lymph node metastasis and/or histologic or nuclear Grade 2–3, which are criteria that have been applied recently in Japan28); 3) surgery undergone within the previous 4–18 months; 4) no chemotherapy or completed chemotherapy. Patients were excluded from participation if they had severe mental disorders or dementia or if they had cancer at another site diagnosed.
Eligible subjects were mailed a description of the psychosocial group intervention study. It informed them that almost all cancer patients experienced psychologic distress and that the study would determine whether psychosocial group intervention, which has been shown to be effective in Western countries, is effective in improving the quality of life of Japanese patients with primary breast carcinoma. We asked whether they wished to participate in the study and also asked them to complete a self-rating scale, the Hospital Anxiety and Depression Scale (HADS), to find and exclude patients with severe mental disorders from participation in the study. Our previous study, in which the score distributions on the scale had been assessed, allowed us to define major depression as a total score of ≥ 20.29 In addition, to confirm the presence of major depression in patients who scored ≥ 20 on the HADS, they were assessed according to the Diagnostic and Statistical Manual of Mental Disorders IV criteria by A.K. in a telephone interview. Patients who had major depression diagnosed were excluded and referred to mental health professionals for individual psychotherapy. All eligible patients were asked to return the questionnaire by mail within 1 week.
Patients who wished to participate in the intervention and met the eligibility criteria were randomly assigned to either an experimental group or a wait-list control group by using a table of random numbers. Individuals then were called and invited to participate in the assigned groups. All patients provided written informed consent before the first assessment.
The psychologic data were collected from the experimental group at the baseline, at 6 weeks, and at 6 months, at the same place in the hospital where the intervention was conducted. The wait-list control group completed the questionnaires at the same time as the experimental group in another room in the hospital. The wait-list control patients were offered the same intervention after the collection of 6-month data. A wait-list control design was utilized because of perceived ethical problems in the control group.21, 30
Because previous studies have reported that group intervention is more cost efficient than individual intervention,22, 31–34 and several studies have shown it to be as effective,31, 35, 36 we used a group model in this study. In addition, because of the longer survival time of primary breast carcinoma patients than women with other cancers,37 we thought it would be beneficial to offer them a psychosocial intervention with a cognitive-behavioral approach that aims to cope with the long term psychologic distress associated with cancer and its treatment.38, 39
We based our intervention model on the structured psychosocial group intervention model for cancer patients of Fawzy and Fawzy12 and Fawzy et al.,40 and modified areas inappropriate for Japanese patients in a pilot study.41 These areas, which were identified to require significant changes, were mainly provision of medical information, family support style, patients' concerns, and communication style in the intervention.
The model consisted of four components: 1) health education; 2) coping skills training; 3) stress management; and 4) psychosocial support. Groups of 6–10 patients met for 1.5 hours weekly for 6 weeks. The same two therapists, who were a psychiatrist and a clinical psychologist, led each experimental group. The modified version of the intervention was reviewed in weekly peer supervision by the authors to sustain the consistency of the therapy. In the health education component, medical and psychologic information specific to breast carcinoma was presented. Medical information was given in a question-and-answer style to maximize the available time during the intervention and to ensure that the participants received the information they wanted. We also provided handouts and reading materials related to each session. In the coping skills component, the patients were taught to utilize the active-cognitive and active-behavioral coping methods when they encountered specific problems related to having cancer. We presented pictures illustrating eight common problems/situations encountered by primary breast carcinoma patients in Japan. The situations illustrated included: diagnosis, treatment, body image, family support, communicating with friends and coworkers, physician–patient relationship, fear of recurrence, and planning for the future. Each situation was presented in two different pictures that described short scenarios of ineffective and effective coping methods. The patients were encouraged to apply the effective coping methods pictured to their own situations. In the stress management component, they were taught relaxation exercises, including progressive muscle relaxation (PMR) followed by guided imagery (GI). At the end of the first session, each patient was provided with a 20-minute instructional audiotape, and it was recommended that she practice PMR with GI independently using the tape at home twice a day. Psychologic support was offered by the staff throughout the intervention, and within-group support was provided by the patients themselves.
The patients in the wait-list control group had no contact with the therapists until the intervention began. No patient missed more than one session.
Psychologic distress, coping with having cancer, and clinical anxiety and depression were assessed using three scales: the Profile of Mood States (POMS), the Mental Adjustment to Cancer (MAC) scale, and the Hospital Anxiety and Depression Scale (HADS), respectively.
The POMS is a 65-item self-rating scale (including 7 dummy items) that measures 6 emotional states (tension/anxiety, depression/dejection, anger/hostility, vigor, fatigue, and confusion) and total mood disturbance (TMD). This last is a summary score of the emotional state subscales.42 Each item is rated on a scale of 0 to 4, ranging from “not at all” to “extremely.” The minimum and maximum possible TMD score is −32 and 200, respectively, with higher scores indicating greater distress. The validity and reliability of the Japanese version of the POMS has been confirmed.43
The MAC scale is a 40-item self-rating scale44 and is used to assess cancer patients' coping style. The scale consists of five subscales: fighting spirit, anxious preoccupation, fatalism, helplessness/hopelessness, and avoidance. Each item is rated on a scale of 1 to 4, ranging from “definitely does not apply to me” to “definitely applies to me,” with higher scores indicating a greater tendency to adopt that coping style. Previous studies have suggested that the MAC scale has adequate validity and reliability.44–46 Our previous study also showed that the Japanese version of the MAC scale is valid and reliable.47
The HADS is a 14-item self-rating scale that measures anxiety and depression.48 Each item is rated on a scale of 0 to 3, with higher scores indicating a greater tendency to anxiety and depression. The Japanese version of HADS has been shown to have adequate validity and reliability.29, 49
Data on demographic characteristics (age, employment status, marital status, having daughter[s], and having children) and clinical variables (time since surgery, type of surgery, histologic and nuclear grade of the tumor, axillary lymph node metastasis positive or negative, treatment by chemotherapy, radiotherapy, and/or hormonal therapy, menopausal status, family history of cancer, and disease stage) were obtained by reviewing the patients' records.
Demographic and clinical characteristics and baseline psychologic scores were tested by the Student t test, chi-square test, or Mann–Whitney U test to assess comparability between the groups.
The effects of an intervention on each of the measures were assessed using repeated measures analysis of covariance (ANCOVA) to test whether there was a difference between the experimental group and the wait-list control group over time, after adjusting for the baseline scores and having or not having undergone chemotherapy. When ANCOVA showed a significant difference, post hoc tests were performed at 6 weeks and 6 months independently to determine whether the difference between the groups for each period was statistically significant, using least square (LS) means for considering the difference in the baseline scores of the groups.
Because multiple comparisons were done, the P value was set at 0.01. All data analyses were conducted using the SAS statistical software package (SAS Institute, Cary, NC).
Of the 151 eligible patients, 126 responded (response rate, 83.4%) and 53 (35.1%) wished to participate in the psychosocial intervention (Fig. 1). Seventy-three patients refused to participate, and these reasons were mainly social barriers such as work (31 subjects), child care (14 subjects), and geographic distance from the study site (14 subjects). The subjects who wished to participate in the intervention were significantly older than those who did not (mean age ± standard deviation [SD], 53.6 ± 7.0, 50.5 ± 8.6, t = 2.16; P = 0.03) when we compared demographic variables between these subjects.
Of the 53 patients who wished to participate, 3 were excluded, 2 because they had scores above 20 on the HADS and were assessed as having major depression at the time of recruitment, and 1 because of recurrence before randomization. Accordingly, 50 (33.1%) patients satisfied all eligibility criteria and were randomly assigned to study groups. The intervention was conducted in three consecutive waves on three experimental groups and three control groups.
All 50 patients completed the baseline and 6-week assessment, but 4 (8.0%) patients dropped out during the follow-up period (Fig. 1). Two of the four dropouts were in the experimental group. One of them could not complete the 6-month follow-up assessment because she was faced with her husband's suicide and was severely depressed at the time, and the other refused further assessment. One of the patients in the wait-list control group could not attend the assessment because she had been admitted for treatment of a newly diagnosed cancer at another site during the waiting period, and the other declined to attend because of recurrence during the waiting period. The dropouts were not significantly different regarding any demographic or clinical variables or any dependent measures at the baseline from those who completed all assessments.
Characteristics of the Experimental and Control Groups
The demographic and clinical variables did not differ significantly between the experimental and wait-list control groups, with the exception of a higher rate of having undergone chemotherapy in the experimental group (Table 1). Therefore, this was controlled for in the multiple analysis of each of the outcomes.
|Characteristic||Experimental (n = 25 [100%])||Control (n = 25 [100%])||P value|
|Continuous variablesa (mean (SD))|
|Age (yrs)||52.6 (6.8)||54.3 (7.5)||NS|
|Time since surgery (mos)||9.4 (4.4)||9.2 (3.8)||NS|
|Full time||10 (40)||11 (44)|
|Part time||4 (16)||2 (8)|
|Unemployed||11 (44)||12 (48)|
|Married||22 (88)||20 (80)|
|Divorced/separated/widowed||3 (12)||5 (20)|
|Having daughter(s)||16 (64)||15 (60)||NS|
|Having children (< 20 yrs)||3 (12)||4 (16)||NS|
|Menopausal status (postmenopausal)||12 (48)||14 (56)||NS|
|Type of surgery||NS|
|Mastectomy||18 (72)||17 (68)|
|Lumpectomy||7 (28)||7 (28)|
|Other||0 (0)||1 (4)|
|1||1 (4)||2 (8)|
|2||12 (48)||13 (52)|
|3||11 (44)||10 (40)|
|Unknown||1 (4)||0 (0)|
|1||2 (8)||1 (4)|
|2||10 (40)||12 (48)|
|3||12 (48)||12 (48)|
|Unknown||1 (4)||0 (0)|
|Axillary lymph node metastasis (positive)||12 (48)||16 (64)||NS|
|Chemotherapy (have undergone)||17 (68)||9 (36)||0.02|
|Radiation therapy (have undergone)||7 (28)||8 (32)||NS|
|Hormonal therapy (tamoxifen) (have undergone)||8 (32)||10 (40)||NS|
|Family history of cancer (positive)||10 (40)||16 (64)||NS|
|I||5 (20)||2 (8)|
|II||19 (76)||21 (84)|
|III||1 (4)||2 (8)|
Effect of Intervention on Psychologic Distress
At the baseline, there were no significant differences between the experimental and wait-list groups in any psychologic distress variables measured by the POMS (Table 2).
|Group||Group × time|
|Baselinea (mean [SD])||6 wks (mean [SD])||6 mos (mean [SD])||Fb||P value||Fb||P value|
|Experimental||8.1 (3.5)||7.9 (4.0)||6.4 (3.1)|
|Control||8.5 (5.6)||8.8 (4.7)||9.2 (5.2)||4.86||0.03||2.16||0.15|
|Experimental||7.4 (6.3)||5.3 (4.8)||5.3 (5.1)|
|Control||8.0 (7.8)||8.1 (7.5)||7.4 (6.5)||4.13||0.04||0.70||0.41|
|Experimental||5.3 (5.0)||4.8 (5.3)||5.3 (6.7)|
|Control||6.0 (5.5)||6.3 (6.0)||6.3 (6.3)||0.45||0.51||0.49||0.49|
|Experimental||12.2 (5.2)||15.9 (5.9)||14.7 (5.6)|
|Control||14.8 (5.2)||13.3 (6.5)||13.2 (5.0)||10.80||0.002||0.38||0.54|
|Experimental||7.0 (5.6)||5.9 (5.4)||5.9 (5.1)|
|Control||6.4 (5.8)||7.5 (6.6)||7.7 (6.0)||4.44||0.04||0.06||0.81|
|Experimental||6.6 (3.6)||5.9 (2.8)||5.2 (2.5)|
|Control||6.6 (3.9)||7.2 (3.7)||7.0 (4.3)||3.61||0.06||0.09||0.76|
|Total mood disturbance: (−32 to 200c)|
|Experimental||22.2 (19.5)||13.8 (21.3)||13.4 (20.7)|
|Control||20.7 (26.4)||24.6 (27.5)||24.4 (25.6)||9.73||0.003||0.02||0.90|
The repeated measures ANCOVA, which controlled the baseline scores and having or not having undergone chemotherapy, revealed a significant between-group difference over the study period in the vigor score of the POMS (F = 10.80, P = 0.002) (Table 2). Post hoc testing showed that the vigor score in the experimental group was significantly higher than in the control group at 6 weeks (LS mean ± SD, 16.9 ± 0.95, 12.5 ± 0.94, F = 10.33, P = 0.002) as well as at 6 months (LS mean ± SD, 15.6 ± 0.97, 12.0 ± 0.97, F = 6.61, P = 0.01). The repeated measures ANCOVA also showed a significant between-group difference over the study period for the TMD score of the POMS (F = 9.73, P = 0.003) (Table 2). Post hoc examination demonstrated that the TMD score in the experimental group was significantly lower than in the control group both at 6 weeks (LS mean ± SD, 12.7 ± 3.35, 25.1 ± 3.34, F = 6.73, P = 0.01) and at 6 months (LS mean ± SD, 13.3 ± 2.99, 25.1 ± 3.00, F = 7.52, P = 0.009). No group-by-time interaction was found for any subscales of the POMS (Table 2), because the baseline scores of the experimental and control groups were adjusted and the experimental group showed consistently lower or higher scores at all subsequent time points.
There were no significant differences among the three experimental groups or among the three control groups in any variables measured by the POMS for all of the 3 study periods (baseline, 6 weeks, 6 months).
Effect of Intervention on Coping
At the baseline, the MAC fighting spirit scale in the experimental group was significantly lower than in the wait-list group (t = 2.16, P = 0.04) (Table 3), but no statistically significant differences between the groups were observed in other MAC scales.
|Group||Group × time|
|Baseline (mean [SD])||6 wks (mean [SD])||6 mos (mean [SD])||Fa||P value||Fa||P value|
|Fighting spirit (16–64b)|
|Experimental||48.8c (5.2)||51.8 (6.4)||50.5 (8.0)|
|Control||52.3c (6.3)||51.0 (5.6)||50.7 (6.1)||8.37||0.006||0.24||0.62|
|Experimental||8.5 (2.2)||7.6 (2.2)||8.5 (2.5)|
|Control||8.4 (2.5)||8.4 (1.9)||8.3 (2.2)||0.98||0.33||2.54||0.12|
|Anxious preoccupation (9–36d)|
|Experimental||23.0 (3.9)||22.6 (3.7)||22.0 (4.2)|
|Control||22.4 (3.8)||23.0 (4.2)||22.0 (3.6)||0.96||0.33||0.05||0.82|
|Experimental||18.1 (3.9)||17.0 (4.1)||17.6 (3.7)|
|Control||18.4 (4.2)||18.2 (4.2)||18.3 (4.3)||0.42||0.52||0.56||0.46|
|Experimental||1.7 (0.7)||2.0 (1.0)||1.8 (0.9)|
|Control||1.9 (0.9)||2.0 (0.8)||1.9 (0.9)||0.27||0.61||0.03||0.87|
We conducted repeated measures ANCOVA for the MAC fighting spirit scale, and this revealed a significant between-group difference over the study period (F = 8.37, P = 0.006) (Table 3). Post hoc test showed that the fighting spirit score in the experimental group was significantly higher than in the control group at 6 weeks (LS mean ± SD, 53.3 ± 0.85, 49.4 ± 0.85, F = 9.97, P = 0.003). The significant improvement in the experimental group was marginally sustained at the 6-month follow-up (LS mean ± SD, 52.0 ± 1.16, 48.9 ± 1.16, F = 3.48, P = 0.07). No statistically significant between-group differences or group-by-time interactions were observed in other subscales.
There were no significant differences among the three experimental groups or among the three control groups in any of the coping variables measured by the MAC for the 3 study periods (baseline, 6 weeks, 6 months).
Effect of Intervention on Anxiety and Depression
Although the anxiety and depression levels on the HADS decreased markedly in the experimental group over time, no significant between-group differences or significant group-by-time interactions were shown (Table 4).
|Group||Group × time|
|Baselinea (mean [SD])||6 wks (mean [SD])||6 mos (mean [SD])||Fb||P value||Fb||P value|
|Experimental||4.9 (2.4)||4.0 (2.4)||3.7 (2.4)|
|Control||4.8 (2.6)||4.3 (2.2)||4.2 (2.5)||0.71||0.40||0.01||0.98|
|Experimental||4.5 (3.4)||3.0 (2.4)||2.7 (2.3)|
|Control||3.4 (2.7)||2.4 (2.1)||2.7 (2.1)||1.77||0.19||1.33||0.26|
With regard to relaxation exercises, 14 of 23 (61%) completers in the experimental group reported that they practiced PMR with GI at home once or twice a day. Regarding psychologic support within group members, all three experimental groups had sustained support outside the group sessions after the end, and almost all of them claimed that the support had been very helpful because it enabled them to talk to each other freely about various related issues.
This randomized trial demonstrated the effects of a psychosocial group intervention on psychologic distress and on adaptive coping style among Japanese patients with primary breast carcinoma. To our knowledge, this is the first report on a randomized controlled trial of a psychosocial group intervention for Japanese cancer patients. Our study also showed that the short term intervention had long term effects on psychologic distress and coping, the results being consistent with those reported by Fawzy et al.40
Assessment of the effect on psychologic distress indicated a significant decrease in total mood disturbance on the POMS over the study period. This finding was in agreement with the results of previous studies.10, 17, 40, 50–52 One possible reason why the subscales of the POMS did not reveal significant effects of the intervention, with the exception of the vigor scale, is the small sample size in the current study. Effect sizes of psychosocial interventions for cancer patients are considered small, with typical ranges of 0.20 to 0.40.18, 53 Therefore, a larger sample size may have been needed to detect significant differences in the subscales on the POMS. However, almost all of the subscales had nonsignificant trends in reducing psychologic distress in the long term. Therefore, we suggest that this psychosocial intervention would be a fairly good vehicle for patients with primary breast carcinoma who have to deal with the long term psychologic distress associated with cancer and its treatment. There are some potential explanations for our result. First, it may have been influenced by the effect of the health education component. In some countries, many cancer patients do not want to know the truth about their illness.54–57 This tendency also may hold in Japan, where indirect or implicit disclosure is common.58–60 Therefore, we structured sessions to give medical information in a question-and-answer style to give participants only the information they wanted. Otherwise, although cancer patients generally are not given information about their illness by physicians in Japan,61–63 all the subjects of this study, who were treated at the National Cancer Center Hospital East, were given information about diagnosis, treatment benefits, risks and the right to refuse treatment.64 They may have been fairly satisfied with medical information from their doctors, and thus the question-and-answer style of health education may be effective. Second, the effect of the intervention on reducing psychologic distress may have been because two-thirds of the participants continued to practice relaxation training at home after the intervention period had ended. This component may have explained the effectiveness. Third, the outcome may have been influenced not only by within-group support during the intervention, but also by informal mutual support after the intervention.
Assessment of the effect on coping revealed an effect on fighting spirit. Among the several different types of coping, fighting spirit has consistently been considered the most beneficial response, especially in breast carcinoma patients.65–70 Thus, we suggest that the long term effect on fighting spirit may be because the intervention provided participants with the skills needed to cope with their situation when the 6-week intervention had ended, and the skills may have been used effectively for 6 months. The study, however, did not show any effect on the remaining maladaptive types of coping: helplessness, anxious preoccupation, fatalism, and avoidance.44, 47 One reason for this may have been the coping skills component. In this component, although we presented two pictures describing both ineffective and effective coping methods, we discussed only the effective one and encouraged the participants to apply it to their own situations, because the time available for the intervention was limited. The brief program might have been less effective for participants with an ineffective, maladaptive style of coping, although it was effective for adaptive coping.
Although we tried to address fear of cancer recurrence in the coping skills component, we were unable to clarify whether any improvement resulted. One reason may have been the measures we adopted in the study, which were unable to measure fear of recurrence specifically. Another reason may have been due to the method of coping skills training. In this component, we discussed fear of recurrence in only one session, and most of the participants felt it difficult to focus on this specific topic. Thus, our approach may not be able to ameliorate fear of recurrence. However, one study has stated that primary breast carcinoma patients at higher risk of recurrence should be offered psychologic adjuvant therapy,71 and another has stated that most patients who are informed of the risk of breast carcinoma recurrence might prefer more intensive follow-up.72 Based on these reports, psychosocial intervention will become a useful means of support in primary breast carcinoma patients with higher risk, and thus higher fear, of recurrence when making treatment decisions and during follow-up. Further modification of the coping skills component of the intervention is needed.
It is noteworthy that the quality of life of these Japanese cancer patients was improved by psychosocial group intervention. A previous study pointed out that any attempt to apply Western-developed intervention models to Japanese persons without considering differences in cultural contexts, such as family structure, life cycle, and communication style, would fail to achieve its effect.59 Accordingly, we identified inappropriate areas, i.e., provision of medical information, family support style, participants' concerns, and communication style of the intervention in the Western-developed model,12 and modified the model in a pilot study.41 Although 3 of 10 (30%) participants dropped out earlier in the pilot study, no participants dropped out during the intervention period when the modified model was used in this study, and it was shown to be effective. This suggests that psychosocial group intervention can be applied to Japanese cancer patients when cultural differences are taken into account.
The participation rate in this trial was lower than those achieved in previous studies conducted in Western countries, which have ranged from 60% to 87%.10, 30, 31, 40, 73 Moreover, there were differences in age between the subjects who wished to participate in the intervention and those who did not. Cultural differences probably explained the lower participation rate in this study. First, the result may have been influenced by the attitude of Asian women in not seeking professional assistance for psychosocial problems created by cancer experience.74 Second, Japanese cancer patients usually repress their emotions about having cancer.75 Those who refused to participate may have concealed any cancer-associated morbidity. Another possible explanation for the lower participation rate was the age of the subjects, because child care was one of the cited reasons for not participating in the intervention, and older subjects were significantly more likely to participate. Another factor may have been difficulty of access to the hospital where the intervention was to be held, as shown by nonparticipants.
The generalizability of our findings is uncertain. First, our study was limited to a small number of subjects, and there was a significant difference in age between the subjects who participated and those who did not. Second, the study utilized a wait-list control design. Third, the intervention in this study included four components. The effectiveness of each component would only be clarified by additional studies. Finally, another report has stated that blinded allocation to treatment may be impossible in behavioral trials,76 and, in fact, we were unable to blind the participants to treatment allocation. In addition, participants were informed that intervention might benefit them, and that information and their expectation alone may have affected the results. Further studies are needed to address these limitations. Nevertheless, the current study explored the effects of a psychosocial group intervention on primary breast carcinoma patients in Japan, and our findings provide encouragement and a direction for future research in the application of psychosocial intervention to Asian cancer patients who are in need of psychosocial support.
The authors thank Ms. Yuko Kojima, Naomi Suimon, Kumiko Harada, and Ryoko Katayama, at the Psycho-Oncology Division, National Cancer Center Research Institute East, Japan, for their research assistance. The authors are also grateful to Professor Yasuo Ohashi and Dr. Haruhiko Fukuda for their advice on statistical analyses.
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