Breast Cancer
Conditions
Keywords
women couples counseling groups support intervention marriage
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.
Interventions
BEHAVIORALGroup Counseling
Group counseling
Sponsors
Christiana Care Health Services
Abington Memorial Hospital
Albert Einstein College of Medicine
The Cooper Health System
Virtua Health
City University of New York, School of Public Health
National Cancer Institute (NCI)
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed