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Sponsors and Collaborators: |
Pittsburgh Mind-Body Center at Carnegie Mellon University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00416780 |
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 | Intervention |
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Breast Cancer Psychosocial Effects of Cancer and Its Treatment |
Other: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized |
Official Title: | Psychobiological Pathways: Breast Cancer Interventions |
Estimated Enrollment: | 350 |
OBJECTIVES:
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).
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.
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.
Ages Eligible for Study: | 25 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosed with breast cancer
First-time diagnosis of stage I or II disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000459773, PMBC-HS05-182, MWH-99-062, CMU-00000603, FWA00004206 |
Study First Received: | December 27, 2006 |
Last Updated: | July 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00416780 History of Changes |
Health Authority: | United States: Federal Government |
psychosocial effects of cancer and its treatment recurrent breast cancer stage I breast cancer stage II breast cancer stage IV breast cancer |
Skin Diseases Breast Neoplasms Breast Diseases Recurrence |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |