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

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
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
NCT ID
NCT00416780
First Posted
December 27, 2006
Last Updated
May 29, 2013
Sponsor
Pittsburgh Mind-Body Center at Carnegie Mellon University
Collaborators
National Cancer Institute (NCI)
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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