Couple-Focused Intervention for Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940277
• Other study ID #: CA-65727
• Secondary ID: R01CA078084-07IR
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: February 2, 2016
• Start date: December 2007
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Fox Chase Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 611
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Group Counseling
Group counseling

Locations

Country	Name	City	State
United States	Bryn Mawr Hospital	Bryn Mawr	Pennsylvania
United States	Christiana Care Health System	Newark	Delaware
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Cooper Health System	Voorhees	New Jersey
United States	Virtua Health System	Voorhees	New Jersey

Sponsors (8)

Lead Sponsor	Collaborator
Fox Chase Cancer Center	Abington Memorial Hospital, Albert Einstein College of Medicine of Yeshiva University, Christiana Care Health Services, City University of New York, School of Public Health, National Cancer Institute (NCI), The Cooper Health System, Virtua Health

Country where clinical trial is conducted

United States, 

References & 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/a0 — View 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. — View 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,

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental Health Inventory		time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention	No
Primary	Impact of Events Scale-Revised		baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention	No
Primary	Well-being Subscale of the Mental Health Inventory (MHI)		baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention	No
Secondary	Mental Outcomes Survey (MOS SF-36)		baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention	No
Secondary	Adherence to Chemotherapy		1 yr follow-up	No
Secondary	Adherence to Radiation Therapy		1 yr follow-up	No