A Couples Approach to Enhance Breast Cancer Survivorship - Full Text View

Sponsors and Collaborators:	University of North Carolina Duke University
Information provided by:	The University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:	NCT00665899

Purpose

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 projects 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.

Condition	Intervention
Early-Stage Breast Cancer	Behavioral: Cancer-Focused Relationship Enhancement Behavioral: Couple's Cancer Education Other: Cancer-Related Community and Internet Resources

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Couples Approach to Enhance Breast Cancer Survivorship

Further study details as provided by The University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning [ Time Frame: Pre, post, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Observational coding of couples social support and decision making conversations [ Time Frame: pre, post, 6 month follow-up, 12 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	292
Study Start Date:	July 2004
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cancer-Focused Relationship Enhancement	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.
2: Experimental Couple's Cancer Education	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.
3: No Intervention Cancer-Related Community and Internet Resources	Other: Cancer-Related Community and Internet Resources Couples receive a list of names and contact information for community and national support groups, breast cancer organizations, and other resources; they do not meet with a health educator.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665899

Contacts

Contact: Donald H Baucom, Ph.D.	919-962-5082	don_baucom@unc.edu
Contact: Laura S Porter, Ph.D.	919-416-3436	laura.porter@duke.edu

Locations

United States, North Carolina
University of North Carolina at Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Donald Baucom, Ph.D. 919-962-5082 don_baucom@unc.edu
Principal Investigator: Donald H Baucom, Ph.D.
Duke University Medical Center	Recruiting
Durham, North Carolina, United States, 27708
Contact: Laura Porter, Ph.D. 919-416-3436 laura.porter@duke.edu
Principal Investigator: Laura S Porter, Ph.D.

Sponsors and Collaborators

University of North Carolina

Duke University

Investigators

Principal Investigator:	Donald H Baucom, Ph.D.	The University of North Carolina, Chapel Hill
Principal Investigator:	Laura S Porter, Ph.D.	Duke University

More Information

CanThrive Website This link exits the ClinicalTrials.gov site

Publications:

Zimmermann T, Heinrichs N, Baucom DH. "Does one size fit all?" moderators in psychosocial interventions for breast cancer patients: a meta-analysis. Ann Behav Med. 2007 Nov-Dec;34(3):225-39.

Baucom DH, Porter LS, Kirby JS, Gremore TM, Keefe FJ. Psychosocial issues confronting young women with breast cancer. Breast Dis. 2005-2006;23:103-13. Review.

Responsible Party:	University of North Carolina at Chapel Hill ( Donald H. Baucom, Principal Investigator )
Study ID Numbers:	04-0977, 1 R01 CA107477-01
Study First Received:	April 22, 2008
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00665899
Health Authority:	United States: Institutional Review Board

Keywords provided by The University of North Carolina, Chapel Hill:

breast cancer
couples
cognitive behavioral therapy
Women with early stage breast cancer and their partners.

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009