Clinical trial NCT00665899: A Couples Approach to Enhance Breast Cancer Survivorship
Official title: A Couples Approach to Enhance Breast Cancer Survivorship
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early-Stage Breast Cancer
Keywords: breast cancer
couples
cognitive behavioral therapy
Women with early stage breast cancer and their partners.
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: National Cancer Institute (NCI)
First posted: 2008-04-24
Enrollment: 163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning
timeFrame: Pre, post, 6 month follow-up, 12 month follow-up
Secondary outcomes:
measure: Observational coding of couples social support and decision making conversations
timeFrame: pre, post, 6 month follow-up, 12 month follow-up
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Donald H Baucom, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Laura S Porter, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1007/BF02874548.
citation: 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. doi: 10.3233/bd-2006-23114.