Cancer Clinical Trial
Official title:
Stress Management Therapy for Patients Undergoing Chemotherapy
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.
OBJECTIVES:
Primary
- Determine if a self-administered stress management intervention is effective in
improving quality of life and decreasing psychological distress (anxiety and
depression) in Hispanic and non-Hispanic patients receiving cancer chemotherapy.
Secondary
- Determine if the degree of acculturation in Hispanics influences the observed
helpfulness of the intervention.
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.
- Arm I (self-administered stress management training plus usual psychosocial care):
Patients receive a video DVD, audio CD, and brochure that provides information and
instruction in 3 stress management training techniques (progressive muscle relaxation
training and guided imagery, abdominal breathing, and coping skills training) to use
during chemotherapy. Patients also receive usual psychosocial care.
- Arm II (usual psychosocial care only): Patients receive usual psychosocial care.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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