Clinical trial NCT00940277: Couple-Focused Intervention for Breast Cancer Patients
Official title: Couple-Focused Group Intervention for Women With Early-Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: women couples counseling groups support intervention marriage
Lead sponsor: Fox Chase Cancer Center
Sponsor class: OTHER
Collaborators: name: Christiana Care Health Services
name: Abington Memorial Hospital
name: Albert Einstein College of Medicine
name: The Cooper Health System
name: Virtua Health
name: City University of New York, School of Public Health
name: National Cancer Institute (NCI)
First posted: 2009-07-15
Enrollment: 611
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Mental Health Inventory
timeFrame: time of consent/baseline, 1 week post-intervention, 6 months post-intervention, 12 months post-intervention
measure: Impact of Events Scale-Revised
timeFrame: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention
measure: Well-being Subscale of the Mental Health Inventory (MHI)
timeFrame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
Secondary outcomes:
measure: Mental Outcomes Survey (MOS SF-36)
timeFrame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention
measure: Adherence to Chemotherapy
timeFrame: 1 yr follow-up
measure: Adherence to Radiation Therapy
timeFrame: 1 yr follow-up
Other outcomes:
Locations:
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Voorhees
country: United States
facility: Cooper Health System
state: New Jersey
city: Voorhees
country: United States
facility: Virtua Health System
state: New Jersey
city: Bryn Mawr
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
Study officials:
affiliation: Fox Chase Cancer Center
name: Sharon L Manne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.