Psychoeducational Intervention for Patients With Cutaneous Malignant Melanoma: A Replication Study
http://www.100md.com
▲還散笫雖悝◎
the Institute of Cancer Epidemiology, Danish Cancer Society
Department of Plastic Surgery and Burn Unit, Rigshospitalet, University of Copenhagen, Copenhagen
Department of Plastic Surgery, Herlev Hospital, University of Copenhagen, Herlev Ringvej, Copenhagen County
Department of Plastic and Reconstructive Surgery, Roskilde University Hospital, Roskilde, Denmark
ABSTRACT
PATIENTS AND METHODS: A total of 262 patients with primary cutaneous malignant melanoma were randomly assigned to the control or intervention group. Patients in the intervention group were offered six weekly sessions of 2 hours of psychoeducation, consisting of health education, enhancement of problem-solving skills, stress management, and psychological support. The participants were assessed at baseline before random assignment and 6 and 12 months after surgery. The analyses of the main effects of the intervention were based on analyses of covariance.
RESULTS: The patients in the intervention group showed significantly less fatigue, greater vigor, and lower total mood disturbance compared with the controls, and they used significantly more active-behavioral and active-cognitive coping than the patients in the control group. The improvements were only significant at first follow-up.
CONCLUSION: The findings of this study support the results of an earlier intervention study among patients with malignant melanoma and indicate that a psychoeducational group intervention for such patients can decrease psychological distress and enhance effective coping. However, this effect is short term and the clinical relevance is not obvious.
INTRODUCTION
A large replication study by Spiegel et al2 on long-term supportive-expressive group therapy among women with metastatic breast cancer did not find increased survival but showed improved mood, primarily in women who were initially more distressed.7 Similar results regarding reduced traumatic stress symptoms were reported in another replication study from the United States.8 It seems that strategies that focus solely on emotional support through peer discussion may be less helpful for patients with primary cancer.9,10 An intervention combining cognitive therapy with supportive-expressive therapy for women with primary breast cancer found only small improvements in mood and mental adjustment.11
Fawzy et al12 used structured psychoeducational group interventions for patients with primary malignant melanoma; in combination with cognitive behavioral therapy, these interventions have been shown to decrease anxiety and/or depression.13每18 The results of studies that involved only information strategies or behavioral approaches (relaxation or meditation training) showed that just one of the two types of interventions may suffice.19每24
Research has shown that patients with poor problem-solving abilities and feelings of lack of control also report higher levels of depressive symptoms and anxiety, indicating that interventions aimed at improving coping skills may thereby reduce depression and anxiety.25每27 Interventions that aim to increase self-efficacy seem to promote better adjustment to cancer.28 In a meta-analysis of psychosocial intervention components, interventions with a greater number of components related to social cognitive theory gave better quality-of-life outcomes than interventions with fewer or no such components.29 In the study by Fawzy et al,30 a positive correlation was found between use of active coping and decreased distress, which supports the suggested association between coping and psychological well-being. Fawzy et al30 suggested that the enhanced survival found among the patients in the intervention group is linked to improved compliance with follow-up routines and preventive health behavior, which may reflect increased self-efficacy. Components closely related to social cognitive theory are coping abilities, problem solving, and stress management, which is the focus of the intervention by Fawzy et al.12
Psychosocial intervention studies that show psychological benefits for cancer patients must be replicated, preferably in large-scale studies, to validate their results. We conducted a randomized, controlled intervention trial of 241 patients with primary cutaneous malignant melanoma. The intervention was based on the structured psychoeducational group model of Fawzy et al12 for United States cancer patients; however, it was slightly modified to fit Danish cancer patients. Our hypotheses were that psychoeducation among a group of Danish patients with malignant melanoma would decrease psychological distress and improve active coping methods and health behavior. We report the effect of the intervention on psychological distress measured by Profile of Mood States (POMS) scale and coping measured by the Dealing With Illness Inventory-Revised (DWI-R),31 which was a revised version of the Dealing With Illness Inventory (DWI), developed by Fawzy et al. Results on survival will be reported when 3-year follow-up data are obtained in 2005.
PATIENTS AND METHODS
Of the 399 patients who met the inclusion criteria, 262 (66%) agreed to participate and 137 (34%) refused to participate because of the distance involved or lack of time, or because they felt no need for support.
Of the 131 patients originally assigned to the intervention group, three (2%) were excluded from the questionnaire analyses; one patient had a cancer diagnosis before inclusion, one received immunotherapy, and one patient died before the start of the intervention. Another 16 patients (12%) dropped out of the intervention group before it started (nine patients) or after one session (seven patients). All patients who dropped out cited the time or the distance involved, or they felt no need for support. Because of ethical concerns, the 16 patients who dropped out were not asked to continue in the study with follow-up questionnaires. These exclusions left 112 patients in the intervention group.
Of the 131 patients originally assigned to the control group, two dropped out shortly after random assignment (one due to disappointment because of control status and the other for an unknown reason), leaving 129 patients in the control group.
Baseline Clinical Measures
Information about the prior and current health status of patients in both arms was obtained from medical records at the hospitals where they had been treated, and included information on sentinel node dissection and lymph node status. Clinical information on the malignant melanoma included tumor thickness; histologic level of invasion; location and type of melanoma; surgical treatment; and presence of ulceration, satellites, and regression.
Outcome Measures
Patients in both groups were asked to complete a questionnaire identical to the baseline questionnaire 6 and 12 months after surgery. For patients in the intervention group, the time between the end of the intervention and completion of the first follow-up questionnaire varied from 1 to 60 days. For 46 patients, the intervention started late and therefore ended more than 6 months after surgery. For these patients, the first follow-up questionnaire was administered 1 day after the end of the intervention.
The questionnaire covered sociodemographic information. The POMS scale33 was used to measure psychological distress. This instrument contains 65 items to measure six mood or affective states: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. The results are summed to a total mood disturbance (TMD) score for affective state. Numerous studies have used the scale and demonstrated that it is valid and reliable.2,8,20,34每36 Coping styles were elicited from the DWI-R,31 a revised questionnaire originally developed to measure the ability of patients to cope with newly diagnosed AIDS, for which it showed internal consistency. Fawzy et al30,37 also used the scale to measure the coping methods of cancer patients in two studies, and he revised the scale on the basis of these results because some questions regarding sexual behavior were ill suited for cancer patients. The revised questionnaire (DWI-R) comprises 50 items to assess cognitive and behavioral means of dealing with serious illness (see Appendix). The responses are categorized into three general coping methods: the active-behavioral method, the active-cognitive method, and avoidance. High scores indicate greater use of a particular coping method. The revised scale was used for this study. Scales included in this study to measure alcohol, smoking, and exercise habits have been used in large-scale population-based Danish cross-sectional surveys.38 However, follow-up data revealed that the questionnaires were not suited for a small cohort like ours because the questionnaire could not measure small changes (eg, the majority of the patients in our study accumulated in the middle category of five possible answers to exercise habits). The questions used to measure sun behavior were derived by the experimenter and not validated, which limits the value of this scale. For these reasons, results on health behavior are not published.
Group Intervention
The psychoeducational intervention was offered between 3 weeks and 4 months after surgery to groups of eight to 10 patients. This intervention was organized into six sessions lasting approximately 2.5 hours each and conducted over a 6-week period, based on the manual developed by Fawzy et al.12 Two physicians provided a health education component consisting of information about malignant melanoma and proper follow-up routines. Two nurses provided patients with information on cancer-preventive behavior, particularly regarding the hazards of exposure to the sun. This health education component differed from the original intervention manual12 in that specialized health staff and not the group therapist provided the information. The group therapist (psychologist) provided a method for stress management and a coping method. The stress management component was divided into two sections: stress awareness, during which the participants were provided with stress monitor questionnaires to increase their awareness about stress, and actual management of stress, during which patients were taught simple relaxation exercises (relaxation followed by guided imagery) and encouraged to use this technique daily by using a complementary compact disk with relaxation and imagery exercises. In the coping method component, the participants were introduced to the concepts of active and avoidance coping and effective problem solving, and asked to apply these methods in specific situations. According to the original intervention manual, the patients should discuss the different coping methods based on illustrations of coping scenarios.12 However, we changed this approach to discussions of the patients' own experiences and problems on the basis of questions about various topics (eg, "How did you react when you discovered the mole") because the patients in the first intervention group raised objections to the scenarios in their evaluation of the intervention. Psychological support was available from two perspectives: the supportive climate provided by discussions among patients, and the presence of a group therapist throughout all sessions.
Statistical Analysis
Baseline characteristics were compared using {chi}2 test for categoric variables. The continuous variables (age and tumor thickness) were tested using the Mann-Whitney U test. Baseline values for POMS and DWI-R were tested using the Mann-Whitney U test.
The analyses of the main effect of the intervention were based on analyses of covariance of the difference between the score at follow-up and the baseline score. The two follow-up times were analyzed separately and the analyses were adjusted for the baseline value. We evaluated sex, age, marital status, tumor thickness, and the baseline value of TMD and DWI-R as possible effect modifiers. These evaluations were performed in larger models including the baseline value interacting with intervention and the specific potential effect modifier interacting with intervention. We also evaluated the effect in models including all main effects of the covariates and all first-order interactions between intervention and the covariates with similar results.
RESULTS
Effects of Psychoeducation on Mood Disturbance
The main effect of the intervention on distress is summarized in Table 3. A significantly larger average decrease in the TMD score was observed in the intervention group compared with the control group at first follow-up (P = .04). The difference between the groups was mainly caused by differences on the subscales for vigor (P = .003) and fatigue (P = .04), respectively. No differences in TMD were observed at 12-month follow-up.
We found a significant interaction with the baseline value for TMD at first follow-up (P = .001), indicating that the beneficial effect of the intervention was larger for patients with higher baseline values. The interaction was mainly seen on the depression (P = .001), anger (P = .008), and fatigue (P = .01) subscales. For patients with baseline TMD scores ≡ 30, the mean change (standard error of the mean [SEM]) at first follow-up was 每35.88 (SEM, 7.19) in the intervention group (n = 16), compared with 每14.48 (SEM, 7.68) in the control group (n = 23; data not shown).
The only statistically significant interaction between intervention and the background variables was an interaction with marital status at the first follow-up, for which a significantly stronger effect of the intervention was seen for married patients (TMD, P = .03). No other significant interactions with treatment group were seen (TMD, all P > .11).
Effects of Psychoeducation on Coping Methods
The main effect of the intervention on coping capacity is listed in Table 3. The intervention group used significantly more active-behavioral coping and active-cognitive coping than the control group at 6-months follow-up. No differences were seen at 12-month follow-up. No significant differences between the two groups were observed for avoidance coping.
There were no significant interactions between intervention and baseline values (all P > .11), but there was a significant interaction between intervention and marital status, with a significantly stronger effect of the intervention for married patients (behavioral coping, P = .05; cognitive coping, P = .01), limited to the first follow-up time. No other significant interactions with treatment group were seen (all P > .13).
DISCUSSION
The methodological advantages of our study are the substantial number of participants and the population-based recruitment of patients (the project nurse approached approximately 80% of the total eligible patients in eastern Denmark). A limitation, however, is that 16 patients in the intervention group and two in the control group dropped out, and for ethical reasons no follow-up data were obtained. There were no significant differences between dropouts and participants on the TMD score, but the dropouts from the intervention group seemed more anxious than participants, which could bias the results. If the effect of the intervention is strongest among the most distressed patients, the results might have been more pronounced if the 16 patients had not dropped out. Conversely, if dropping out were due to the kind of intervention offered and the 16 dropouts would not have decreased their level of distress during follow-up, the results might be biased toward overestimation of the effect. Given that half of the participants who dropped out did so before the intervention started, and the reasons for dropping out most often were time or distance involved, the participants in the two randomization groups appeared to be comparable on all variables including anxiety. Therefore, we still believe that the results are valid.
Another limitation to this study was the use of an unvalidated version of the coping questionnaire derived by Namir et al31 for a study among AIDS patients and later revised by Fawzy et al30,37 for studies among cancer patients. The revised questionnaire needs to be validated for a Danish population of cancer patients. The results of this study on coping methods should therefore be interpreted with caution. However, for reasons of comparison, it seems reasonable to include this questionnaire.
The beneficial psychosocial effects observed in this intervention study are consistent with previous reports of the benefits of psychoeducational or cognitive behavioral group therapy among patients with malignant melanoma30,37 and other cancer diagnoses.13每16 The psychobehavioral factors reflected in the vigor and fatigue subscales (functional ability) were affected most by the intervention. This result was in accordance with the findings of Fawzy et al,30 who found improvements in these subscales.
In contrast to the results of our study, four trials showed that the level of anxiety decreased significantly in the intervention group compared with the control group.13每15,36 Five studies reported a decrease in the level of depression.16每18,30,36 In our study, the intervention did not affect the level of anxiety or depression, possibly because of low levels of anxiety and depression at baseline that were difficult to reduce further.
Belief in one's own coping abilities has been shown to predict more adaptive psychological and physiological functioning,39 which is associated with higher quality of life.29 The patients in the intervention group used more of the active-behavioral and active-cognitive coping methods than controls; this result was also found by Fawzy et al.30 Improving the use of adaptive coping by providing information and teaching problem solving and stress management may be the pathway to the improved mood found in this study, which is also supported by the positive correlation between adaptive coping and decreased distress found by Fawzy et al.30
The revision of the intervention used for the Danish patients might be necessary to meet cultural differences between the United States and Denmark. A Japanese study also used a revised version of the intervention strategy by Fawzy et al40 and found an effect on coping methods and psychological distress.36 These results indicate that the psychoeducational intervention developed by Fawzy et al12 can be applied with relevant modifications to patients from a wide cultural range with a beneficial effect on coping methods.
However, the average beneficial effects of the intervention were modest. This might be due to the low baseline TMD scores on the POMS scale for both treatment groups, which indicate that most participants in this study had accepted their diagnosis better than the patients in other studies of melanoma patients,30,41,42 and much better than other groups of cancer patients.7,8,43,44 This finding obviously calls into question the need for psychosocial support at all, and the modest average effect of our study on psychological distress also calls into question the clinical relevance of the results. Goodwin et al7 showed an effect of a psychosocial intervention only for women who were initially more distressed; our study also found a stronger effect among the more distressed patients. The intervention should perhaps be limited to these more distressed patients, given that they seemed to benefit the most from the intervention; furthermore, previous studies have shown an effect on those who on a screening test were suffering from psychological distress.14,16,44每46
There are reasons to believe that the overall improvement of the TMD score as well as the changes in the use of behavioral and cognitive coping capacities reflect true patterns because the results are in line with those of Fawzy et al.30,37 With necessary modifications of the original intervention model developed by Fawzy et al30 to meet cultural differences between countries, it was possible to find beneficial effect of psychoeducation for Danish patients with malignant melanoma, especially among those who were most distressed at baseline. However, the average effect was modest and an evaluation of the clinical relevance of the intervention awaits the future study of survival.
Appendix
The questionnaire was developed with AIDS in mind (Namir et al31); several of the questions are inappropriate for cancer and therefore have been dropped. Other items were being interpreted in different ways by cancer patients and have been reworded. The changes are outlined in the following lists.
Items deleted from the questionnaire:
32. Got involved in political activities
33. Increased sex with others
44. Increased sex with self
Items reworded:
6. Accepted the reality of my diagnosis but not that I had to automatically accept a poor prognosis
32. Accepted the situation and got on with doing what needed to be done
33. Felt that it was my doctor＊s responsibility to make treatment decisions for me
36. I was assertive (with medical staff, family, friends) about what I thought was best for me
38. Released my feelings somehow (eg, cried, yelled, laughed) instead of holding them in
40. Believed that there was nothing I could do but wait since only time would make a difference
44. Resigned myself to the situation since nothing could be done
45. I have trust (respect, faith, belief) in my doctor＊s medical knowledge and technical skills
49. Tried to work together with my doctor to decide what is best for me (ie, established a collaborative relationship with my doctor)
50. Thought about how much better off I am than some other people with my illness
Authors' Disclosures of Potential Conflicts of Interest
Acknowledgment
We thank the Plastic Surgery Departments of Rigshospitalet, Herlev, and Roskilde Hospital for excellent cooperation; Nancy Fawzy, RN, DNSc, the John Wayne Cancer Institute, for kindly letting the author (E.H.B.) watch a group intervention; and all of the patients participating in the study.
NOTES
Supported by the Psychosocial Research Committee, The Danish Cancer Society (9722559 and PP01016), and the IMK Foundation (5322569).
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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17. Marchioro G, Azzarello G, Checchin F, et al: The impact of a psychological intervention on quality of life in non-metastatic breast cancer. Eur J Cancer 32A:1612每1615, 1996
18. Edelman S, Bell DR, Kidman AD: A group cognitive behaviour therapy programme with metastatic breast cancer patients. Psychooncology 8:295每305, 1999
19. Burish TG, Snyder SL, Jenkins RA: Preparing patients for cancer chemotherapy: Effect of coping preparation and relaxation interventions. J Consult Clin Psychol 59:518每525, 1991
20. McQuellon RP, Wells M, Hoffman S, et al: Reducing distress in cancer patients with an orientation program. Psychooncology 7:207每217, 1998
21. Ali NS, Khalil HZ: Effect of psychoeducational intervention on anxiety among Egyptian bladder cancer patients. Cancer Nurs 12:236每242, 1989
22. Davis H: Effects of biofeedback and cognitive therapy on stress in patients with breast cancer. Psychol Rep 59:967每974, 1986
23. Bindemann S, Soukop M, Kaye SB: Randomised controlled study of relaxation training. Eur J Cancer 27:170每174, 1991
24. Speca M, Carlson LE, Goodey E, et al: A randomized, wait-list controlled clinical trial: The effect of a mindfulness meditation-based stress reduction program on mood and symptoms of stress in cancer outpatients. Psychosom Med 62:613每622, 2000
25. Nezu AM, Nezu CM, Houtset al: Relevance of problem-solving therapy to psychosocial oncology. J Psychosoc Oncol 16:5每26, 1999
26. Brennan J: Adjustment to cancer-coping or personal transition Psychooncology 10:1每18, 2001
27. Taylor SE, Helgeson VS, Reed GM, et al: Self-generated feelings of control and adjustment to physical illness. J Soc Issues 47:91每109, 1991
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37. Fawzy NW: A psychoeducational nursing intervention to enhance coping and affective state in newly diagnosed malignant melanoma patients. Cancer Nurs 18:427每438, 1995
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39. Bandura A: Self-Efficacy: The Exercise of Control. New York, NY, W.H. Freeman, 1997
40. Fukui S, Kamiya M, Koike M, et al: Applicability of a Western-developed psychosocial group intervention for Japanese patients with primary breast cancer. Psychooncology 9:169每177, 2000
41. Baider L, Perry S, Sison A, et al: The role of psychological variables in a group of melanoma patients: An Israeli sample. Psychosomatics 38:45每53, 1997
42. Fawzy FI, Fawzy NW, Arndt LA, et al: Critical review of psychosocial interventions in cancer care. Arch Gen Psychiatry 52:100每113, 1995
43. Cassileth BR, Lusk EJ, Brown L, et al: Psychosocial status of cancer patients and next of kin: Normative data from the Profile of Mood States. J Psychosoc Oncol 3:99每105, 1985
44. Telch CF, Telch MJ: Group coping skills instruction and supportive group therapy for cancer patients: A comparison of strategies. J Consult Clin Psychol 54:802每808, 1986
45. Evans RL, Connis RT: Comparison of brief group therapies for depressed cancer patients receiving radiation treatment. Public Health Rep 110:306每311, 1995
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Department of Plastic Surgery and Burn Unit, Rigshospitalet, University of Copenhagen, Copenhagen
Department of Plastic Surgery, Herlev Hospital, University of Copenhagen, Herlev Ringvej, Copenhagen County
Department of Plastic and Reconstructive Surgery, Roskilde University Hospital, Roskilde, Denmark
ABSTRACT
PATIENTS AND METHODS: A total of 262 patients with primary cutaneous malignant melanoma were randomly assigned to the control or intervention group. Patients in the intervention group were offered six weekly sessions of 2 hours of psychoeducation, consisting of health education, enhancement of problem-solving skills, stress management, and psychological support. The participants were assessed at baseline before random assignment and 6 and 12 months after surgery. The analyses of the main effects of the intervention were based on analyses of covariance.
RESULTS: The patients in the intervention group showed significantly less fatigue, greater vigor, and lower total mood disturbance compared with the controls, and they used significantly more active-behavioral and active-cognitive coping than the patients in the control group. The improvements were only significant at first follow-up.
CONCLUSION: The findings of this study support the results of an earlier intervention study among patients with malignant melanoma and indicate that a psychoeducational group intervention for such patients can decrease psychological distress and enhance effective coping. However, this effect is short term and the clinical relevance is not obvious.
INTRODUCTION
A large replication study by Spiegel et al2 on long-term supportive-expressive group therapy among women with metastatic breast cancer did not find increased survival but showed improved mood, primarily in women who were initially more distressed.7 Similar results regarding reduced traumatic stress symptoms were reported in another replication study from the United States.8 It seems that strategies that focus solely on emotional support through peer discussion may be less helpful for patients with primary cancer.9,10 An intervention combining cognitive therapy with supportive-expressive therapy for women with primary breast cancer found only small improvements in mood and mental adjustment.11
Fawzy et al12 used structured psychoeducational group interventions for patients with primary malignant melanoma; in combination with cognitive behavioral therapy, these interventions have been shown to decrease anxiety and/or depression.13每18 The results of studies that involved only information strategies or behavioral approaches (relaxation or meditation training) showed that just one of the two types of interventions may suffice.19每24
Research has shown that patients with poor problem-solving abilities and feelings of lack of control also report higher levels of depressive symptoms and anxiety, indicating that interventions aimed at improving coping skills may thereby reduce depression and anxiety.25每27 Interventions that aim to increase self-efficacy seem to promote better adjustment to cancer.28 In a meta-analysis of psychosocial intervention components, interventions with a greater number of components related to social cognitive theory gave better quality-of-life outcomes than interventions with fewer or no such components.29 In the study by Fawzy et al,30 a positive correlation was found between use of active coping and decreased distress, which supports the suggested association between coping and psychological well-being. Fawzy et al30 suggested that the enhanced survival found among the patients in the intervention group is linked to improved compliance with follow-up routines and preventive health behavior, which may reflect increased self-efficacy. Components closely related to social cognitive theory are coping abilities, problem solving, and stress management, which is the focus of the intervention by Fawzy et al.12
Psychosocial intervention studies that show psychological benefits for cancer patients must be replicated, preferably in large-scale studies, to validate their results. We conducted a randomized, controlled intervention trial of 241 patients with primary cutaneous malignant melanoma. The intervention was based on the structured psychoeducational group model of Fawzy et al12 for United States cancer patients; however, it was slightly modified to fit Danish cancer patients. Our hypotheses were that psychoeducation among a group of Danish patients with malignant melanoma would decrease psychological distress and improve active coping methods and health behavior. We report the effect of the intervention on psychological distress measured by Profile of Mood States (POMS) scale and coping measured by the Dealing With Illness Inventory-Revised (DWI-R),31 which was a revised version of the Dealing With Illness Inventory (DWI), developed by Fawzy et al. Results on survival will be reported when 3-year follow-up data are obtained in 2005.
PATIENTS AND METHODS
Of the 399 patients who met the inclusion criteria, 262 (66%) agreed to participate and 137 (34%) refused to participate because of the distance involved or lack of time, or because they felt no need for support.
Of the 131 patients originally assigned to the intervention group, three (2%) were excluded from the questionnaire analyses; one patient had a cancer diagnosis before inclusion, one received immunotherapy, and one patient died before the start of the intervention. Another 16 patients (12%) dropped out of the intervention group before it started (nine patients) or after one session (seven patients). All patients who dropped out cited the time or the distance involved, or they felt no need for support. Because of ethical concerns, the 16 patients who dropped out were not asked to continue in the study with follow-up questionnaires. These exclusions left 112 patients in the intervention group.
Of the 131 patients originally assigned to the control group, two dropped out shortly after random assignment (one due to disappointment because of control status and the other for an unknown reason), leaving 129 patients in the control group.
Baseline Clinical Measures
Information about the prior and current health status of patients in both arms was obtained from medical records at the hospitals where they had been treated, and included information on sentinel node dissection and lymph node status. Clinical information on the malignant melanoma included tumor thickness; histologic level of invasion; location and type of melanoma; surgical treatment; and presence of ulceration, satellites, and regression.
Outcome Measures
Patients in both groups were asked to complete a questionnaire identical to the baseline questionnaire 6 and 12 months after surgery. For patients in the intervention group, the time between the end of the intervention and completion of the first follow-up questionnaire varied from 1 to 60 days. For 46 patients, the intervention started late and therefore ended more than 6 months after surgery. For these patients, the first follow-up questionnaire was administered 1 day after the end of the intervention.
The questionnaire covered sociodemographic information. The POMS scale33 was used to measure psychological distress. This instrument contains 65 items to measure six mood or affective states: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. The results are summed to a total mood disturbance (TMD) score for affective state. Numerous studies have used the scale and demonstrated that it is valid and reliable.2,8,20,34每36 Coping styles were elicited from the DWI-R,31 a revised questionnaire originally developed to measure the ability of patients to cope with newly diagnosed AIDS, for which it showed internal consistency. Fawzy et al30,37 also used the scale to measure the coping methods of cancer patients in two studies, and he revised the scale on the basis of these results because some questions regarding sexual behavior were ill suited for cancer patients. The revised questionnaire (DWI-R) comprises 50 items to assess cognitive and behavioral means of dealing with serious illness (see Appendix). The responses are categorized into three general coping methods: the active-behavioral method, the active-cognitive method, and avoidance. High scores indicate greater use of a particular coping method. The revised scale was used for this study. Scales included in this study to measure alcohol, smoking, and exercise habits have been used in large-scale population-based Danish cross-sectional surveys.38 However, follow-up data revealed that the questionnaires were not suited for a small cohort like ours because the questionnaire could not measure small changes (eg, the majority of the patients in our study accumulated in the middle category of five possible answers to exercise habits). The questions used to measure sun behavior were derived by the experimenter and not validated, which limits the value of this scale. For these reasons, results on health behavior are not published.
Group Intervention
The psychoeducational intervention was offered between 3 weeks and 4 months after surgery to groups of eight to 10 patients. This intervention was organized into six sessions lasting approximately 2.5 hours each and conducted over a 6-week period, based on the manual developed by Fawzy et al.12 Two physicians provided a health education component consisting of information about malignant melanoma and proper follow-up routines. Two nurses provided patients with information on cancer-preventive behavior, particularly regarding the hazards of exposure to the sun. This health education component differed from the original intervention manual12 in that specialized health staff and not the group therapist provided the information. The group therapist (psychologist) provided a method for stress management and a coping method. The stress management component was divided into two sections: stress awareness, during which the participants were provided with stress monitor questionnaires to increase their awareness about stress, and actual management of stress, during which patients were taught simple relaxation exercises (relaxation followed by guided imagery) and encouraged to use this technique daily by using a complementary compact disk with relaxation and imagery exercises. In the coping method component, the participants were introduced to the concepts of active and avoidance coping and effective problem solving, and asked to apply these methods in specific situations. According to the original intervention manual, the patients should discuss the different coping methods based on illustrations of coping scenarios.12 However, we changed this approach to discussions of the patients' own experiences and problems on the basis of questions about various topics (eg, "How did you react when you discovered the mole") because the patients in the first intervention group raised objections to the scenarios in their evaluation of the intervention. Psychological support was available from two perspectives: the supportive climate provided by discussions among patients, and the presence of a group therapist throughout all sessions.
Statistical Analysis
Baseline characteristics were compared using {chi}2 test for categoric variables. The continuous variables (age and tumor thickness) were tested using the Mann-Whitney U test. Baseline values for POMS and DWI-R were tested using the Mann-Whitney U test.
The analyses of the main effect of the intervention were based on analyses of covariance of the difference between the score at follow-up and the baseline score. The two follow-up times were analyzed separately and the analyses were adjusted for the baseline value. We evaluated sex, age, marital status, tumor thickness, and the baseline value of TMD and DWI-R as possible effect modifiers. These evaluations were performed in larger models including the baseline value interacting with intervention and the specific potential effect modifier interacting with intervention. We also evaluated the effect in models including all main effects of the covariates and all first-order interactions between intervention and the covariates with similar results.
RESULTS
Effects of Psychoeducation on Mood Disturbance
The main effect of the intervention on distress is summarized in Table 3. A significantly larger average decrease in the TMD score was observed in the intervention group compared with the control group at first follow-up (P = .04). The difference between the groups was mainly caused by differences on the subscales for vigor (P = .003) and fatigue (P = .04), respectively. No differences in TMD were observed at 12-month follow-up.
We found a significant interaction with the baseline value for TMD at first follow-up (P = .001), indicating that the beneficial effect of the intervention was larger for patients with higher baseline values. The interaction was mainly seen on the depression (P = .001), anger (P = .008), and fatigue (P = .01) subscales. For patients with baseline TMD scores ≡ 30, the mean change (standard error of the mean [SEM]) at first follow-up was 每35.88 (SEM, 7.19) in the intervention group (n = 16), compared with 每14.48 (SEM, 7.68) in the control group (n = 23; data not shown).
The only statistically significant interaction between intervention and the background variables was an interaction with marital status at the first follow-up, for which a significantly stronger effect of the intervention was seen for married patients (TMD, P = .03). No other significant interactions with treatment group were seen (TMD, all P > .11).
Effects of Psychoeducation on Coping Methods
The main effect of the intervention on coping capacity is listed in Table 3. The intervention group used significantly more active-behavioral coping and active-cognitive coping than the control group at 6-months follow-up. No differences were seen at 12-month follow-up. No significant differences between the two groups were observed for avoidance coping.
There were no significant interactions between intervention and baseline values (all P > .11), but there was a significant interaction between intervention and marital status, with a significantly stronger effect of the intervention for married patients (behavioral coping, P = .05; cognitive coping, P = .01), limited to the first follow-up time. No other significant interactions with treatment group were seen (all P > .13).
DISCUSSION
The methodological advantages of our study are the substantial number of participants and the population-based recruitment of patients (the project nurse approached approximately 80% of the total eligible patients in eastern Denmark). A limitation, however, is that 16 patients in the intervention group and two in the control group dropped out, and for ethical reasons no follow-up data were obtained. There were no significant differences between dropouts and participants on the TMD score, but the dropouts from the intervention group seemed more anxious than participants, which could bias the results. If the effect of the intervention is strongest among the most distressed patients, the results might have been more pronounced if the 16 patients had not dropped out. Conversely, if dropping out were due to the kind of intervention offered and the 16 dropouts would not have decreased their level of distress during follow-up, the results might be biased toward overestimation of the effect. Given that half of the participants who dropped out did so before the intervention started, and the reasons for dropping out most often were time or distance involved, the participants in the two randomization groups appeared to be comparable on all variables including anxiety. Therefore, we still believe that the results are valid.
Another limitation to this study was the use of an unvalidated version of the coping questionnaire derived by Namir et al31 for a study among AIDS patients and later revised by Fawzy et al30,37 for studies among cancer patients. The revised questionnaire needs to be validated for a Danish population of cancer patients. The results of this study on coping methods should therefore be interpreted with caution. However, for reasons of comparison, it seems reasonable to include this questionnaire.
The beneficial psychosocial effects observed in this intervention study are consistent with previous reports of the benefits of psychoeducational or cognitive behavioral group therapy among patients with malignant melanoma30,37 and other cancer diagnoses.13每16 The psychobehavioral factors reflected in the vigor and fatigue subscales (functional ability) were affected most by the intervention. This result was in accordance with the findings of Fawzy et al,30 who found improvements in these subscales.
In contrast to the results of our study, four trials showed that the level of anxiety decreased significantly in the intervention group compared with the control group.13每15,36 Five studies reported a decrease in the level of depression.16每18,30,36 In our study, the intervention did not affect the level of anxiety or depression, possibly because of low levels of anxiety and depression at baseline that were difficult to reduce further.
Belief in one's own coping abilities has been shown to predict more adaptive psychological and physiological functioning,39 which is associated with higher quality of life.29 The patients in the intervention group used more of the active-behavioral and active-cognitive coping methods than controls; this result was also found by Fawzy et al.30 Improving the use of adaptive coping by providing information and teaching problem solving and stress management may be the pathway to the improved mood found in this study, which is also supported by the positive correlation between adaptive coping and decreased distress found by Fawzy et al.30
The revision of the intervention used for the Danish patients might be necessary to meet cultural differences between the United States and Denmark. A Japanese study also used a revised version of the intervention strategy by Fawzy et al40 and found an effect on coping methods and psychological distress.36 These results indicate that the psychoeducational intervention developed by Fawzy et al12 can be applied with relevant modifications to patients from a wide cultural range with a beneficial effect on coping methods.
However, the average beneficial effects of the intervention were modest. This might be due to the low baseline TMD scores on the POMS scale for both treatment groups, which indicate that most participants in this study had accepted their diagnosis better than the patients in other studies of melanoma patients,30,41,42 and much better than other groups of cancer patients.7,8,43,44 This finding obviously calls into question the need for psychosocial support at all, and the modest average effect of our study on psychological distress also calls into question the clinical relevance of the results. Goodwin et al7 showed an effect of a psychosocial intervention only for women who were initially more distressed; our study also found a stronger effect among the more distressed patients. The intervention should perhaps be limited to these more distressed patients, given that they seemed to benefit the most from the intervention; furthermore, previous studies have shown an effect on those who on a screening test were suffering from psychological distress.14,16,44每46
There are reasons to believe that the overall improvement of the TMD score as well as the changes in the use of behavioral and cognitive coping capacities reflect true patterns because the results are in line with those of Fawzy et al.30,37 With necessary modifications of the original intervention model developed by Fawzy et al30 to meet cultural differences between countries, it was possible to find beneficial effect of psychoeducation for Danish patients with malignant melanoma, especially among those who were most distressed at baseline. However, the average effect was modest and an evaluation of the clinical relevance of the intervention awaits the future study of survival.
Appendix
The questionnaire was developed with AIDS in mind (Namir et al31); several of the questions are inappropriate for cancer and therefore have been dropped. Other items were being interpreted in different ways by cancer patients and have been reworded. The changes are outlined in the following lists.
Items deleted from the questionnaire:
32. Got involved in political activities
33. Increased sex with others
44. Increased sex with self
Items reworded:
6. Accepted the reality of my diagnosis but not that I had to automatically accept a poor prognosis
32. Accepted the situation and got on with doing what needed to be done
33. Felt that it was my doctor＊s responsibility to make treatment decisions for me
36. I was assertive (with medical staff, family, friends) about what I thought was best for me
38. Released my feelings somehow (eg, cried, yelled, laughed) instead of holding them in
40. Believed that there was nothing I could do but wait since only time would make a difference
44. Resigned myself to the situation since nothing could be done
45. I have trust (respect, faith, belief) in my doctor＊s medical knowledge and technical skills
49. Tried to work together with my doctor to decide what is best for me (ie, established a collaborative relationship with my doctor)
50. Thought about how much better off I am than some other people with my illness
Authors' Disclosures of Potential Conflicts of Interest
Acknowledgment
We thank the Plastic Surgery Departments of Rigshospitalet, Herlev, and Roskilde Hospital for excellent cooperation; Nancy Fawzy, RN, DNSc, the John Wayne Cancer Institute, for kindly letting the author (E.H.B.) watch a group intervention; and all of the patients participating in the study.
NOTES
Supported by the Psychosocial Research Committee, The Danish Cancer Society (9722559 and PP01016), and the IMK Foundation (5322569).
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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