Psychosocial Support in Treating Women With Recurrent Breast Cancer or Stage I, Stage II, or Stage IV Breast Cancer
|ClinicalTrials.gov Identifier: NCT00416780|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : May 30, 2013
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Psychosocial Effects of Cancer and Its Treatment||Other: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care|
- 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 (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Psychobiological Pathways: Breast Cancer Interventions|
|Study Completion Date :||March 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00416780
|Study Chair:||Michael Scheier, PhD||Pittsburgh Mind-Body Center at Carnegie Mellon University|