Early-Stage Breast Cancer
Conditions
Keywords
breast cancer, couples, cognitive behavioral therapy, Women with early stage breast cancer and their partners.
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.
Interventions
BEHAVIORALCancer-Focused Relationship Enhancement
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.
BEHAVIORALCouple's Cancer Education
Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.
Sponsors
Duke University
National Cancer Institute (NCI)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning | Pre, post, 6 month follow-up, 12 month follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Observational coding of couples social support and decision making conversations | pre, post, 6 month follow-up, 12 month follow-up |
Countries
United States
Outcome results
None listed