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Couple-Focused Intervention for Breast Cancer Patients

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Counseling
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring women couples counseling groups support intervention marriage

Eligibility Criteria

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

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

Sites / Locations

  • Christiana Care Health System
  • Cooper Health System
  • Virtua Health System
  • Bryn Mawr Hospital
  • Fox Chase Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Enhanced Couples Group

Support Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mental Health Inventory
Impact of Events Scale-Revised
Well-being Subscale of the Mental Health Inventory (MHI)

Secondary Outcome Measures

Mental Outcomes Survey (MOS SF-36)
Adherence to Chemotherapy
Adherence to Radiation Therapy

Full Information

First Posted
July 14, 2009
Last Updated
February 2, 2016
Sponsor
Fox Chase Cancer Center
Collaborators
Christiana Care Health Services, Abington Memorial Hospital, Albert Einstein College of Medicine, The Cooper Health System, Virtua Health, City University of New York, School of Public Health, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00940277
Brief Title
Couple-Focused Intervention for Breast Cancer Patients
Official Title
Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fox Chase Cancer Center
Collaborators
Christiana Care Health Services, Abington Memorial Hospital, Albert Einstein College of Medicine, The Cooper Health System, Virtua Health, City University of New York, School of Public Health, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
women couples counseling groups support intervention marriage

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
611 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Couples Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Support Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Counseling
Intervention Description
Group counseling
Primary Outcome Measure Information:
Title
Mental Health Inventory
Time Frame
time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
Title
Impact of Events Scale-Revised
Time Frame
baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
Title
Well-being Subscale of the Mental Health Inventory (MHI)
Time Frame
baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Secondary Outcome Measure Information:
Title
Mental Outcomes Survey (MOS SF-36)
Time Frame
baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Title
Adherence to Chemotherapy
Time Frame
1 yr follow-up
Title
Adherence to Radiation Therapy
Time Frame
1 yr follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon L Manne, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Cooper Health System
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Virtua Health System
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24611691
Citation
Manne S, Kashy DA, Siegel S, Myers Virtue S, Heckman C, Ryan D. Unsupportive partner behaviors, social-cognitive processing, and psychological outcomes in couples coping with early stage breast cancer. J Fam Psychol. 2014 Apr;28(2):214-24. doi: 10.1037/a0036053. Epub 2014 Mar 10.
Results Reference
result
PubMed Identifier
25242854
Citation
Manne SL, Siegel S, Kashy D, Heckman CJ. Cancer-specific Relationship Awareness, Relationship Communication, and Intimacy Among Couples Coping with Early Stage Breast Cancer. J Soc Pers Relat. 2014 May;31(3):314-334. doi: 10.1177/0265407513494950.
Results Reference
result
Citation
Manne, S. & Ostroff, J. (2011). Couple-focused group intervention for women diagnosed with early stage breast cancer and their partners. In. D. Kissane & M Watson (Eds.), IPOS Academy Handbook of Psychotherapies in Cancer Care. (pp. 129-139). Chichester, UK: Wiley.
Results Reference
result

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Couple-Focused Intervention for Breast Cancer Patients

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