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A Couples Approach to Enhance Breast Cancer Survivorship (CanThrive)

This study has been completed.
Sponsor:
Collaborator:
Duke University
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00665899
First received: April 22, 2008
Last updated: February 21, 2011
Last verified: February 2011
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Couples Approach to Enhance Breast Cancer Survivorship

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ]

Enrollment: 163
Study Start Date: July 2004
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Experimental: 2
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.
No Intervention: 3
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

Locations
United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27708
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Duke University
Investigators
Principal Investigator: Donald H Baucom, Ph.D. University of North Carolina, Chapel Hill
Principal Investigator: Laura S Porter, Ph.D. Duke University
  More Information

Publications:

Responsible Party: Donald H. Baucom, Principal Investigator, University of North Carolina at Chapel Hill
ClinicalTrials.gov Identifier: NCT00665899     History of Changes
Other Study ID Numbers: 04-0977, 1 R01 CA107477-01
Study First Received: April 22, 2008
Last Updated: February 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
breast cancer
couples
cognitive behavioral therapy
Women with early stage breast cancer and their partners.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013