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.

Completed

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Key information

Conditions

Early-Stage Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cancer-Focused Relationship Enhancement

Behavioral

Couples meet individually with a health educator for 6 sessions to learn about ways to support each other and communicate about breast cancer related issues.

Couple's Cancer Education

Behavioral

Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.

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

Time frame: pre, post, 6 month follow-up, 12 month follow-up

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

Duke University
National Cancer Institute (NCI)

Registry information

Acronym: CanThrive

Important dates

Study start: 2004
Primary completion: 2010
Study completion: 2010
First posted: Apr 24, 2008
Registry last updated: Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed