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A Couples Approach to Enhance Breast Cancer Survivorship (CanThrive)

Primary Purpose

Early-Stage Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cancer-Focused Relationship Enhancement

Couple's Cancer Education

About this trial

This is an interventional supportive care trial for Early-Stage Breast Cancer focused on measuring breast cancer, couples, cognitive behavioral therapy, Women with early stage breast cancer and their partners.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of North Carolina at Chapel Hill
Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Cancer-Focused Relationship Enhancement

Couple's Cancer Education

Usual Care

Arm Description

Cancer-Focused Relationship Enhancement

Couple's Cancer Education

Cancer-Related Community and Internet Resources

Outcomes

Primary Outcome Measures

Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning

Secondary Outcome Measures

Observational coding of couples social support and decision making conversations

Full Information

NCT ID

NCT00665899

First Posted

April 22, 2008

Last Updated

October 25, 2016

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Duke University, National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00665899

Brief Title

A Couples Approach to Enhance Breast Cancer Survivorship

Acronym

CanThrive

Official Title

A Couples Approach to Enhance Breast Cancer Survivorship

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Duke University, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early-Stage Breast Cancer

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

163 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cancer-Focused Relationship Enhancement

Arm Type

Experimental

Arm Description

Cancer-Focused Relationship Enhancement

Arm Title

Couple's Cancer Education

Arm Type

Experimental

Arm Description

Couple's Cancer Education

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

Cancer-Related Community and Internet Resources

Intervention Type

Behavioral

Intervention Name(s)

Cancer-Focused Relationship Enhancement

Intervention Description

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

Intervention Name(s)

Couple's Cancer Education

Intervention Description

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

Primary Outcome Measure Information:

Title

Relationship Functioning, Individual Functioning, Cancer Related Physical Functioning

Time Frame

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

Secondary Outcome Measure Information:

Title

Observational coding of couples social support and decision making conversations

Time Frame

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald H Baucom, Ph.D.

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Laura S Porter, Ph.D.

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27708

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18020933

Citation

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.

Results Reference

background

PubMed Identifier

16823173

Citation

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.

Results Reference

background

Links:

URL

http://www.canthrive.org

Description

CanThrive Website

Learn more about this trial

A Couples Approach to Enhance Breast Cancer Survivorship

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