Couple-Focused Intervention for Breast Cancer Patients
NCT00940277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 611
Last updated 2016-02-03
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.
Conditions
Interventions
- BEHAVIORAL
-
Group Counseling
Group counseling
Sponsors & Collaborators
-
Christiana Care Health Services
collaborator OTHER -
Abington Memorial Hospital
collaborator OTHER -
Albert Einstein College of Medicine
collaborator OTHER -
The Cooper Health System
collaborator OTHER -
Virtua Health
collaborator OTHER -
City University of New York, School of Public Health
collaborator OTHER -
National Cancer Institute (NCI)
collaborator NIH -
Fox Chase Cancer Center
lead OTHER
Principal Investigators
-
Sharon L Manne, PhD · Fox Chase Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-12-31
- Primary Completion
- 2014-10-31
- Completion
- 2015-10-31
Countries
- United States
Study Locations
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