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A Couples Approach to Enhance Breast Cancer Survivorship

NCT00665899 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 163

Last updated 2016-10-27

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Cancer-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.

BEHAVIORAL

Couple'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 & Collaborators

  • Duke University

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Donald H Baucom, Ph.D. · University of North Carolina, Chapel Hill

  • Laura S Porter, Ph.D. · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00665899 on ClinicalTrials.gov