Couple-Focused Intervention for Breast Cancer Patients
- Conditions
- Breast Cancer
- Registration Number
- NCT00940277
- Lead Sponsor
- Fox Chase Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mental Health Inventory time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention Well-being Subscale of the Mental Health Inventory (MHI) baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention Impact of Events Scale-Revised baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (5)
Christiana Care Health System
🇺🇸Newark, Delaware, United States
Cooper Health System
🇺🇸Voorhees, New Jersey, United States
Virtua Health System
🇺🇸Voorhees, New Jersey, United States
Bryn Mawr Hospital
🇺🇸Bryn Mawr, Pennsylvania, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Christiana Care Health System🇺🇸Newark, Delaware, United States