Couple-Focused Intervention for Breast Cancer Patients

Study Overview
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Brief Summary
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The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation. The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG. The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.

Official Title
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Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Group Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer patient has had breast cancer surgery within the last twelve months patient and partner married or cohabitating patient and partner 18 years of age or older patient and partner speak and read English patient and partner can provide meaningful informed consent patient and partner do not have any chronic physical or cognitive illness that would preclude participation in the group sessions couple lives within 2 hour commuting distance to the center from which they are recruited Exclusion criteria: - patient is male

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced Couples Group<br>Enhanced Couples Group: consists of eight 90-minute sessions, conducted weekly. ECG has a didactic educational content presented by the group leader or practice of specific relationship communication, relationship support, and couple-focused stress management. ECG participants are also given instruction about what types of behaviors are unsupportive and training in how to not behave in an unsupportive manner. | Behavioral: Group Counseling<br>* Group counseling<br>|
| Experimental: Support Group<br>Support Group: 8 weekly 90-minute group counseling sessions. Using a standard approach to supportive therapy, the group interventionists will focus on encouraging participants to share their experiences with cancer, express their emotions related to the experience, voice problems they have in coping with the cancer, and offer support and advice to other members of the group. The co-facilitators will facilitate expression of affect and the sharing of the group's common issues related to cancer. Each session has a broad topic for discussion. Topics include communication with health care providers, issues related to occupational life, and coping with medical procedures and treatment. No formal or didactic information will be provided. | Behavioral: Group Counseling<br>* Group counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Health Inventory |  | time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention | 
| Impact of Events Scale-Revised |  | baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention | 
| Well-being Subscale of the Mental Health Inventory (MHI) |  | baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental Outcomes Survey (MOS SF-36) |  | baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention | 
| Adherence to Chemotherapy |  | 1 yr follow-up | 
| Adherence to Radiation Therapy |  | 1 yr follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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women couples counseling groups support intervention marriage