NCT00940277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
611

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

6.8 years

First QC Date

July 14, 2009

Last Update Submit

February 2, 2016

Conditions

Breast Cancer

Keywords

women couples counseling groups support intervention marriage

Outcome Measures

Primary Outcomes (3)

  • Mental Health Inventory

    time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention

  • Impact of Events Scale-Revised

    baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention

  • Well-being Subscale of the Mental Health Inventory (MHI)

    baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention

Secondary Outcomes (3)

  • Mental Outcomes Survey (MOS SF-36)

    baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention

  • Adherence to Chemotherapy

    1 yr follow-up

  • Adherence to Radiation Therapy

    1 yr follow-up

Study Arms (2)

Enhanced Couples Group

EXPERIMENTAL

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

Support Group

EXPERIMENTAL

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

Interventions

Group CounselingBEHAVIORAL

Group counseling

Enhanced Couples GroupSupport Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- patient is male

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Cooper Health System

Voorhees Township, New Jersey, 08043, United States

Location

Virtua Health System

Voorhees Township, New Jersey, 08043, United States

Location

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19001, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Publications (3)

  • 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.

    PMID: 24611691RESULT

  • 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.

    PMID: 25242854RESULT

  • 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.

    RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sharon L Manne, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

December 1, 2007

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(5)