A Couples Approach to Enhance Breast Cancer Survivorship

Not Applicable

Completed

• Conditions: Early-Stage Breast Cancer
• Interventions: Behavioral: Cancer-Focused Relationship Enhancement; Behavioral: Couple's Cancer Education

• Registration Number: NCT00665899
• Lead Sponsor: University of North Carolina, Chapel Hill

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2008-04-22
• Study First Submitted QC: 2008-04-23
• Study First Posted: 2008-04-24
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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

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Exclusion Criteria

• Stage 3b and above breast cancer
• Notable psychopathology, including severe depression with suicidality

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cancer-Focused Relationship Enhancement	Cancer-Focused Relationship Enhancement	Cancer-Focused Relationship Enhancement
Couple's Cancer Education	Couple's Cancer Education	Couple's Cancer Education

Primary Outcome Measures

Name	Time	Method
Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning	Pre, post, 6 month follow-up, 12 month follow-up

Secondary Outcome Measures

Name	Time	Method
Observational coding of couples social support and decision making conversations	pre, post, 6 month follow-up, 12 month follow-up

Trial Locations

Locations (2)

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States