A Couples Approach to Enhance Breast Cancer Survivorship

NCT ID: NCT00665899

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Early-Stage Breast Cancer

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cancer-Focused Relationship Enhancement

Cancer-Focused Relationship Enhancement

Group Type EXPERIMENTAL

Cancer-Focused Relationship Enhancement

Intervention Type BEHAVIORAL

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.

Couple's Cancer Education

Couple's Cancer Education

Group Type EXPERIMENTAL

Couple's Cancer Education

Intervention Type BEHAVIORAL

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

Usual Care

Cancer-Related Community and Internet Resources

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald H Baucom, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Laura S Porter, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18020933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16823173 (View on PubMed)

Related Links

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http://www.canthrive.org

CanThrive Website

Other Identifiers

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1R01CA107477-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LCC 0402

Identifier Type: OTHER

Identifier Source: secondary_id

04-0977

Identifier Type: -

Identifier Source: org_study_id