Couple-Focused Intervention for Breast Cancer Patients

NCT00940277 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2016-02-03

No results posted yet for this study

Summary

The goal of the proposed study is to evaluate the efficacy of 2 couple-focused interventions developed to reduce the psychological distress on women and their partners during and after the breast cancer experience. The first group, an Enhanced Couple-Focused Group (ECG), incorporates cognitive-behavioral interventions (e.g., relaxation, stress management skills) as well as basic relationship communication and support skills (e.g., expressing support needs constructively). The second group, a Couples' Support Group (SG), is a non-structured group where general topics are discussed. The investigators will evaluate the impact of each group condition on patients' psychological adaptation, social and role functioning, and cancer treatment adherence. The investigators will also evaluate whether patient and partner perceptions of relationship support, relationship intimacy, stress management skills, and intervention group support mediate the groups' effects on each other's psychological adaptation.

The investigators hypothesize that ECG will have stronger positive effects on patient general and cancer-related distress and well-being than SG.

The investigators hypothesize that group support will mediate greater improvements in patient psychological functioning in both groups but that the effects of group support will be significantly stronger in SG than ECG.

Conditions

Interventions

BEHAVIORAL

Group Counseling

Group counseling

Sponsors & Collaborators

  • Christiana Care Health Services

    collaborator OTHER
  • Abington Memorial Hospital

    collaborator OTHER
  • Albert Einstein College of Medicine

    collaborator OTHER
  • The Cooper Health System

    collaborator OTHER
  • Virtua Health

    collaborator OTHER
  • City University of New York, School of Public Health

    collaborator OTHER
  • National Cancer Institute (NCI)

    collaborator NIH
  • Fox Chase Cancer Center

    lead OTHER

Principal Investigators

  • Sharon L Manne, PhD · Fox Chase Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2014-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00940277 on ClinicalTrials.gov