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A Couples Approach to Enhance Breast Cancer Survivorship (CanThrive)

This study has been completed.
Sponsor:
Collaborators:
Duke University
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00665899
First received: April 22, 2008
Last updated: October 25, 2016
Last verified: October 2016

April 22, 2008
October 25, 2016
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 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.
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.
  • Experimental: Cancer-Focused Relationship Enhancement
    Cancer-Focused Relationship Enhancement
    Intervention: Behavioral: Cancer-Focused Relationship Enhancement
  • Experimental: Couple's Cancer Education
    Couple's Cancer Education
    Intervention: Behavioral: Couple's Cancer Education
  • No Intervention: Usual Care
    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
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00665899
04-0977, 1R01CA107477-01, LCC 0402
Yes
Not Provided
Not Provided
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
  • Duke University
  • National Cancer Institute (NCI)
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
October 2016

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