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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

April 22, 2008
February 21, 2011
July 2004
April 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00665899 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Couples Approach to Enhance Breast Cancer Survivorship
A Couples Approach to Enhance Breast Cancer Survivorship

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Early-Stage Breast Cancer
  • 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.
  • 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.
  • Experimental: 1
    Cancer-Focused Relationship Enhancement
    Intervention: Behavioral: Cancer-Focused Relationship Enhancement
  • Experimental: 2
    Couple's Cancer Education
    Intervention: Behavioral: Couple's Cancer Education
  • No Intervention: 3
    Cancer-Related Community and Internet Resources
    Intervention: Other: Cancer-Related Community and Internet Resources

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00665899
04-0977, 1 R01 CA107477-01
Yes
Donald H. Baucom, Principal Investigator, University of North Carolina at Chapel Hill
University of North Carolina, Chapel Hill
Duke University
Principal Investigator: Donald H Baucom, Ph.D. University of North Carolina, Chapel Hill
Principal Investigator: Laura S Porter, Ph.D. Duke University
University of North Carolina, Chapel Hill
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP