A Couples Approach to Enhance Breast Cancer Survivorship

Study Overview
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Brief Summary
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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.

Official Title
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A Couples Approach to Enhance Breast Cancer Survivorship

Conditions
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Early-Stage Breast Cancer

Intervention / Treatment
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* Behavioral: Cancer-Focused Relationship Enhancement
* Behavioral: Couple's Cancer Education


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cancer-Focused Relationship Enhancement<br>Cancer-Focused Relationship Enhancement | Behavioral: Cancer-Focused Relationship Enhancement<br>* 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.<br>|
| Experimental: Couple's Cancer Education<br>Couple's Cancer Education | Behavioral: Couple's Cancer Education<br>* Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.<br>|
| No Intervention: Usual Care<br>Cancer-Related Community and Internet Resources | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning |  | Pre, post, 6 month follow-up, 12 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observational coding of couples social support and decision making conversations |  | pre, post, 6 month follow-up, 12 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, couples, cognitive behavioral therapy, Women with early stage breast cancer and their partners.