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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00377130 |
RATIONALE: A stress-management program may improve quality of life and reduce anxiety and depression in patients receiving chemotherapy for cancer.
PURPOSE: This randomized clinical trial is studying how well stress management therapy works in patients receiving chemotherapy for cancer.
Condition | Intervention |
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Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific |
Procedure: counseling Procedure: management of therapy complications Procedure: mind-body intervention procedure Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: study of socioeconomic and demographic variables |
Study Type: | Interventional |
Study Design: | Randomized |
Official Title: | Stress Management Therapy for Patients Undergoing Chemotherapy |
Estimated Enrollment: | 442 |
Study Start Date: | December 2006 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, use of psychotropic drugs (yes vs no), and ethnicity (Hispanic vs non-Hispanic). Patients are randomized to 1 of 2 arms.
Patients complete questionnaires to assess mood, quality of life, and other factors at baseline and before chemotherapy courses 2, 3, and 4.
PROJECTED ACCRUAL: A total of 442 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Scheduled to receive ≥ 4 courses of intravenous chemotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Teletia Taylor, PhD | Howard University Cancer Center |
Investigator: | Susan McMillan, PhD, RN, FAAN | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000485314, MCC-0501 |
Study First Received: | September 13, 2006 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00377130 |
Health Authority: | Unspecified |
psychosocial effects/treatment unspecified adult solid tumor, protocol specific |
Stress |