Early-Stage Breast Cancer Clinical Trial
— CanThriveOfficial title:
A Couples Approach to Enhance Breast Cancer Survivorship
The purpose of the proposed study is to evaluate the efficacy of a new couple-based intervention for women with recently diagnosed, early stage breast cancer and their spouses or male partners. This cancer-focused relationship enhancement intervention adapts well-validated cognitive-behavioral interventions to teach patients and partners specific relationship skills, such as problem-solving skills, communication, and maximizing positive interactions, that they can use in addressing breast cancer. This project's major goals are to improve the patient's individual functioning and specific aspects of the couple's relationship affected by breast cancer (e.g., mood, role functioning, sexual functioning, and social support). In the current investigation, cancer-focused relationship enhancement will be compared to (a) a couple-based Cancer Education intervention and (b) a Treatment-as-Usual condition.
| Status | Completed |
| Enrollment | 163 |
| Est. completion date | April 2010 |
| Est. primary completion date | April 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Diagnosed with early stage breast cancer within last year - No history of breast cancer, or other cancers in last 5 years (except skin cancer) - Living together in a committed heterosexual relationship - read and speak English - Agree to participate Exclusion Criteria: - Stage 3b and above breast cancer - Notable psychopathology, including severe depression with suicidality |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| University of North Carolina, Chapel Hill | Duke University, National Cancer Institute (NCI) |
United States,
Baucom DH, Porter LS, Kirby JS, Gremore TM, Keefe FJ. Psychosocial issues confronting young women with breast cancer. Breast Dis. 2005-2006;23:103-13. Review. — View Citation
Zimmermann T, Heinrichs N, Baucom DH. "Does one size fit all?" moderators in psychosocial interventions for breast cancer patients: a meta-analysis. Ann Behav Med. 2007 Nov-Dec;34(3):225-39. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning | Pre, post, 6 month follow-up, 12 month follow-up | No | |
| Secondary | Observational coding of couples social support and decision making conversations | pre, post, 6 month follow-up, 12 month follow-up | No |
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