Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer

May 29, 2013 updated by: Pittsburgh Mind-Body Center at Carnegie Mellon University

Psychobiological Pathways: Breast Cancer Interventions

RATIONALE: Meeting together with other breast cancer patients to receive psychosocial support and to learn to reduce stress may help patients cope with their diagnosis, have a better quality of life, and live more comfortably.

PURPOSE: This randomized clinical trial is studying how well psychosocial support works in treating women with recurrent breast cancer or stage I, stage II, or stage IV breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Evaluate theoretically derived psychosocial interventions (peer discussion support vs education and stress management vs usual-care control) targeted to enhance adjustment and functional status and lower morbidity among women diagnosed with and treated for recurrent or stage I, II, or IV breast cancer.
  • Evaluate the psychological, behavioral, and biological pathways and their effects in patients treated with these interventions.
  • Evaluate the efficacy of these intervention in these patients.
  • Evaluate the nature and extent of coping strategies in these patients.
  • Evaluate the differences in patients treated with these intervention vs those patients electing not to be treated with these interventions.

OUTLINE: This is a randomized study. Patients are stratified according to disease stage (early vs late). Patients with early-stage disease are randomized to 1 of 3 intervention arms. Patients with late-stage disease are randomized to 1 of 2 intervention arms (II or III).

  • Arm I (education and stress management): Patients undergo a 1-hour group (6-10 patients per group) education session once a week for 8 weeks focusing on exchange of factual information between a facilitator and patients. The session includes a 45-minute lecture, discussing risks, diagnosis, and treatment of cancer; side effects from treatment; nutrition during treatment; and follow-up care, followed by a question/answer period and instruction in progressive relaxation techniques. Patients then receive 3 monthly phone calls from a project staff member to answer questions about cancer, treatment, and follow-up care and to discuss the relaxation exercises.
  • Arm II (peer discussion): Patients undergo a 1-hour group (6-10 patients per group) peer support session once a week for 8 weeks focusing on the provision of emotional support among patients and the maintenance of purpose in life. The session emphasizes on the sharing of experiences, the development of a common bond, and the promotion of altruism to similar others. Patients then are given an opportunity to attend 3 monthly additional meetings to share critical experiences and problems they have experienced in the past month.
  • Arm III (control): Patients receive usual care and are not asked to attend any meetings.

All patients undergo a 2-hour baseline interview, a 1.5-hour post intervention interview, and a 1.5-hour final interview 8 months after randomization.

PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Diagnosed with breast cancer

    • First-time diagnosis of stage I or II disease

      • No more than 2 months since prior breast cancer surgery
    • Initial diagnosis of stage IV disease
    • Distant recurrence of prior breast cancer
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Reside within a 60-mile radius of the greater Pittsburgh metropolitan area

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pittsburgh Mind-Body Center at Carnegie Mellon University

Collaborators

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

March 1, 2006

Study Registration Dates

First Submitted

December 27, 2006

First Submitted That Met QC Criteria

December 27, 2006

First Posted (ESTIMATE)

December 28, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMBC-HS05-182
  • CMU-00000603 (cmu)
  • MWH-99-062
  • CDR0000459773 (REGISTRY: PDQ (Physician Data Query))
  • FWA00004206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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