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Clinical Trials/NCT00665899
NCT00665899
Completed
Not Applicable

A Couples Approach to Enhance Breast Cancer Survivorship

University of North Carolina, Chapel Hill2 sites in 1 country163 target enrollmentJuly 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early-Stage Breast Cancer
Sponsor
University of North Carolina, Chapel Hill
Enrollment
163
Locations
2
Primary Endpoint
Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2004
End Date
April 2010
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning

Time Frame: Pre, post, 6 month follow-up, 12 month follow-up

Secondary Outcomes

  • Observational coding of couples social support and decision making conversations(pre, post, 6 month follow-up, 12 month follow-up)

Study Sites (2)

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