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

Primary Purpose

Breast Cancer, Psychosocial Effects of Cancer and Its Treatment

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
counseling intervention
educational intervention
psychosocial assessment and care
Sponsored by
Pittsburgh Mind-Body Center at Carnegie Mellon University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring psychosocial effects of cancer and its treatment, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IV breast cancer

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 27, 2006
    Last Updated
    May 29, 2013
    Sponsor
    Pittsburgh Mind-Body Center at Carnegie Mellon University
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00416780
    Brief Title
    Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
    Official Title
    Psychobiological Pathways: Breast Cancer Interventions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Pittsburgh Mind-Body Center at Carnegie Mellon University
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
    Keywords
    psychosocial effects of cancer and its treatment, recurrent breast cancer, stage I breast cancer, stage II breast cancer, stage IV breast cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Allocation
    Randomized
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    counseling intervention
    Intervention Type
    Other
    Intervention Name(s)
    educational intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    psychosocial assessment and care

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael Scheier, PhD
    Organizational Affiliation
    Pittsburgh Mind-Body Center at Carnegie Mellon University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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