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Psychoeducational Intervention for Patients With Cutaneous Malignant Melanoma: A Replication Study

From 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; and Department of Plastic and Reconstructive Surgery, Roskilde University Hospital, Roskilde, Denmark

Address reprint requests to Ellen H. Boesen, MSc, PhD, Institute of Cancer Epidemiology, Danish Cancer Society, Strandboulevarden 49, DK-2100 Copenhagen, Denmark; e-mail: ellen{at}cancer.dk

	ABSTRACT

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PURPOSE: In 1993, a randomized intervention study among patients with malignant melanoma showed a significant decrease in psychological distress and increased coping capacity 6 months after the intervention and enhanced survival 6 years later. We applied a similar intervention with a few modifications in a randomized controlled trial among Danish patients with malignant melanoma and evaluated results on immediate and long-term effects on psychological distress and coping capacity.

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

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During the last 20 years, more than 40 randomized studies of various psychosocial intervention strategies for cancer patients have been conducted to improve the emotional adjustment and prevent negative psychosocial effects after a cancer diagnosis.¹ The promising results of several randomized psychosocial intervention studies showing improved survival highlight a potential additional area for clinical intervention and research.^2–5,6

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.^13–18 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.^19–24

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.^25–27 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

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Selection Criteria
Eligible patients were 18 to 70 years of age with cutaneous malignant melanoma of T1-4, N1a-2a, M0³² diagnosed and treated in eastern Denmark. Patients were contacted by a project nurse in the outpatient clinics between 3 and 12 weeks after surgery. Patients who gave oral and written consent completed a baseline questionnaire and were then immediately randomly assigned to the intervention or the control group. Randomization was performed with a computer program, which generated a balanced number of random assignments to the two groups in blocks of randomly varying sizes of six, eight, or 10 patients. This ensured equal distribution of patients in the two groups and reduced possible confounding from season or calendar time. Between February 1, 1999, and June 15, 2001, the physicians reported 420 eligible patients for the project. Of these, 21 patients (5%) were excluded before random assignment because of the information obtained at the recruitment interview. These comprised three patients with dementia, one with cognitive deficits after brain damage, two with a diagnosis of a second primary melanoma, four with an unclear pathologic diagnosis, two in whom cancer had been diagnosed before the cutaneous malignant melanoma, one with in situ melanoma, and one with a serious but nonmalignant chronic blood disease. An additional five patients had exceeded the time span for inclusion, and two patients did not attend the medical check-ups.

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.^{2,8,20,34–36} 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 al^30,37 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 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

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Baseline Characteristics
Baseline characteristics are listed in Table 1. No significant differences were observed between the two treatment groups on any variables (all P > .31). Comparison of participants and dropouts showed that relatively more women dropped out (P = .02) of the study. Baseline data for the POMS and the DWI-R are listed in Table 2. No significant differences between the two treatment groups were found on these variables (all P > .25). Comparison of participants and dropouts showed no differences except on the subscale anxiety, for which the dropouts were more anxious than participants (P = .04).

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

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We found an effect of a psychoeducational intervention for patients with malignant melanoma on the TMD of the POMS scale and on the coping capacity (DWI-R) at the first follow-up. The effect on TMD was most pronounced for the patients who were most distressed at baseline. The beneficial effect of the intervention was clearest for the married patients, which is in contrast to previous research indicating that social support might moderate the effectiveness of psychosocial intervention.⁹ However, this was not anticipated, and we attribute the result to a type I error until the association is found by other studies.

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 al^30,37 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 melanoma^30,37 and other cancer diagnoses.^13–16 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.^13–15,36 Five studies reported a decrease in the level of depression.^{16–18,30,36} 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.^{14,16,44–46}

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

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Revision of the Dealing With Illness Inventory (DWI-R)

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

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The authors indicated no 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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Submitted May 29, 2003; accepted November 3, 2004.

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