Couple-Focused Intervention for Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Christiana Care Health Services
Abington Memorial Hospital
Albert Einstein College of Medicine of Yeshiva University
The Cooper Health System
Virtua Health
The City University of New York
Information provided by (Responsible Party):
Fox Chase Cancer Center
ClinicalTrials.gov Identifier:
NCT00940277
First received: July 14, 2009
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

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, 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.


Condition Intervention
Breast Cancer
Behavioral: Group Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Fox Chase Cancer Center:

Primary Outcome Measures:
  • Mental Health Inventory [ Time Frame: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention ] [ Designated as safety issue: No ]
  • Impact of Events Scale-Revised [ Time Frame: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention ] [ Designated as safety issue: No ]
  • Well-being Subscale of the Mental Health Inventory (MHI) [ Time Frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mental Outcomes Survey (MOS SF-36) [ Time Frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention ] [ Designated as safety issue: No ]
  • Adherence to Chemotherapy [ Time Frame: 1 yr follow-up ] [ Designated as safety issue: No ]
  • Adherence to Radiation Therapy [ Time Frame: 1 yr follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 852
Study Start Date: December 2007
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced Couples Group
Enhanced Couples Group: consists of eight 90-minute sessions, conducted weekly. ECG has a didactic educational content presented by the group leader or practice of specific relationship communication, relationship support, and couple-focused stress management. ECG participants are also given instruction about what types of behaviors are unsupportive and training in how to not behave in an unsupportive manner.
Behavioral: Group Counseling
Group counseling
Experimental: Support Group
Support Group: 8 weekly 90-minute group counseling sessions. Using a standard approach to supportive therapy, the group interventionists will focus on encouraging participants to share their experiences with cancer, express their emotions related to the experience, voice problems they have in coping with the cancer, and offer support and advice to other members of the group. The co-facilitators will facilitate expression of affect and the sharing of the group's common issues related to cancer. Each session has a broad topic for discussion. Topics include communication with health care providers, issues related to occupational life, and coping with medical procedures and treatment. No formal or didactic information will be provided.
Behavioral: Group Counseling
Group counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient has a primary diagnosis of Stage 0 (Ductal Carcinoma in situ), 1, 2, or 3a breast cancer
  • patient has had breast cancer surgery within the last twelve months
  • patient and partner married or cohabitating
  • patient and partner 18 years of age or older
  • patient and partner speak and read English
  • patient and partner can provide meaningful informed consent
  • patient and partner do not have any chronic physical or cognitive illness that would preclude participation in the group sessions
  • couple lives within 2 hour commuting distance to the center from which they are recruited

Exclusion criteria:

- patient is male

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940277

Locations
United States, Delaware
Christiana Care Health System
Newark, Delaware, United States, 19713
United States, New Jersey
Cooper Health System
Voorhees, New Jersey, United States, 08043
Virtua Health System
Voorhees, New Jersey, United States, 08043
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19001
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Sponsors and Collaborators
Fox Chase Cancer Center
Christiana Care Health Services
Abington Memorial Hospital
Albert Einstein College of Medicine of Yeshiva University
The Cooper Health System
Virtua Health
The City University of New York
Investigators
Principal Investigator: Sharon L Manne, PhD Fox Chase Cancer Center
  More Information

Publications:
Responsible Party: Fox Chase Cancer Center
ClinicalTrials.gov Identifier: NCT00940277     History of Changes
Other Study ID Numbers: CA-65727, R01CA078084-07, IRB#07-831
Study First Received: July 14, 2009
Last Updated: May 15, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Fox Chase Cancer Center:
women couples counseling groups support intervention marriage

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 29, 2014