Couple-Focused Intervention for Breast Cancer Patients
This study is currently recruiting participants.
Verified May 2013 by Fox Chase Cancer Center
Sponsor:
Fox Chase Cancer Center
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 8, 2013
Last verified: May 2013
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940277
Contacts
| Contact: Sara M Frederick | 215-214-3794 | sara.worhach@fccc.edu |
| Contact: Julianne Lacroce, BA | 215-728-2404 | Julianne.Lacroce@fccc.edu |
Locations
| United States, Delaware | |
| Christiana Care Health System | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Lauren Pigeon 302-623-4876 LPigeon@Christianacare.org | |
| Contact: Scott Siegel, PhD 302-623-4890 SSiegel@Christianacare.org | |
| Principal Investigator: Scott Siegel, PhD | |
| United States, New Jersey | |
| Cooper Health System | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Devaney M Camburn, MS 215-214-1403 Devaney.Camburn@fccc.edu | |
| Contact: Julianne Lacroce, BA 215-728-2404 Julianne.Lacroce@fccc.edu | |
| Principal Investigator: Generosa Grana, MD | |
| Virtua Health System | Recruiting |
| Voorhees, New Jersey, United States, 08043 | |
| Contact: Sara Worhach, MS 215-214-3794 sara.worhach@fccc.edu | |
| Contact: Kristen Sorice, BA 215-214-1433 kristen.sorice@fccc.edu | |
| Principal Investigator: Eric Miller, MD | |
| United States, Pennsylvania | |
| Bryn Mawr Hospital | Recruiting |
| Bryn Mawr, Pennsylvania, United States, 19001 | |
| Contact: Sara Worhach, MS 215-214-3794 sara.worhach@fccc.edu | |
| Contact: kristen sorice, BA 215-214-1433 kristen.sorice@fccc.edu | |
| Principal Investigator: Thomas Frazier, MD | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Sara Worhach, MS 215-214-3794 sara.worhach@fccc.edu | |
| Contact: Kristen Sorice, BA 215-214-1433 kristen.sorice@fccc.edu | |
| Principal Investigator: Sharon L Manne, PhD | |
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
No publications provided
| 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 8, 2013 |
| 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 June 13, 2013