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Completed

NCT Number: NCT00940277

Couple-Focused Intervention for Breast Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christiana Care Health System, Newark, Delaware, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group counseling

Behavioral

Group counseling

Primary outcomes

  1. Mental Health Inventory

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

  2. Impact of Events Scale-Revised

    Time frame: baseline, 1 week post-intervention, 6 mos post-intervention, 12 mos post-intervention

  3. 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 outcomes

  1. Mental Outcomes Survey (MOS SF-36)

    Time frame: baseline, 1 wk post-intervention, 6 mos post-intervention, 12 mos post-intervention

  2. Adherence to Chemotherapy

    Time frame: 1 yr follow-up

  3. Adherence to Radiation Therapy

    Time frame: 1 yr follow-up

Sponsors and collaborators

Lead sponsor

Fox Chase Cancer Center

Other

Collaborators

  • Abington Memorial Hospital
  • Albert Einstein College of Medicine
  • Christiana Care Health Services
  • City University of New York, School of Public Health
  • National Cancer Institute (NCI)
  • The Cooper Health System
  • Virtua Health

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2015
First posted
Jul 15, 2009
Registry last updated
Feb 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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