Trial Information
Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Mental Health Inventory
Outcome Time Frame:
time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
Safety Issue:
No
Principal Investigator
Sharon L Manne, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fox Chase Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CA-65727
NCT ID:
NCT00940277
Start Date:
December 2007
Completion Date:
October 2015
Related Keywords:
- Breast Cancer
- women couples counseling groups support intervention marriage
- Breast Neoplasms
Name | Location |
Fox Chase Cancer Center |
Philadelphia, Pennsylvania 19111 |
Bryn Mawr Hospital |
Bryn Mawr, Pennsylvania 19010 |
Cooper Health System |
Voorhees, New Jersey 08043 |
Christiana Care Health System |
Newark, Delaware 19713 |
Virtua Health System |
Voorhees, New Jersey 08043 |