NCT00665899

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
163

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

5.8 years

First QC Date

April 22, 2008

Last Update Submit

October 25, 2016

Conditions

Early-Stage Breast Cancer

Keywords

breast cancercouplescognitive behavioral therapyWomen with early stage breast cancer and their partners.

Outcome Measures

Primary Outcomes (1)

  • Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning

    Pre, post, 6 month follow-up, 12 month follow-up

Secondary Outcomes (1)

  • Observational coding of couples social support and decision making conversations

    pre, post, 6 month follow-up, 12 month follow-up

Study Arms (3)

Cancer-Focused Relationship Enhancement

EXPERIMENTAL

Cancer-Focused Relationship Enhancement

Behavioral: Cancer-Focused Relationship Enhancement

Couple's Cancer Education

EXPERIMENTAL

Couple's Cancer Education

Behavioral: Couple's Cancer Education

Usual Care

NO INTERVENTION

Cancer-Related Community and Internet Resources

Interventions

Cancer-Focused Relationship EnhancementBEHAVIORAL

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.

Cancer-Focused Relationship Enhancement
Couple's Cancer EducationBEHAVIORAL

Couples meet individually with a health educator for 6 sessions to discuss the medical aspects of breast cancer and treatment options.

Couple's Cancer Education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Stage 3b and above breast cancer
  • Notable psychopathology, including severe depression with suicidality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27708, United States

Location

Related Publications (2)

  • 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. doi: 10.1007/BF02874548.

    PMID: 18020933BACKGROUND

  • 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. doi: 10.3233/bd-2006-23114.

    PMID: 16823173BACKGROUND

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Donald H Baucom, Ph.D.

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Laura S Porter, Ph.D.

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

July 1, 2004

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

US(2)