Stress Management Therapy in Patients Receiving Chemotherapy for Cancer
Summary
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.
Description
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.
Study Design
Allocation: Randomized
Conditions
Psychosocial Effects of Cancer and Its Treatment
Intervention
counseling intervention, study of socioeconomic and demographic variables, management of therapy complications, mind-body intervention procedure, psychosocial assessment and care, quality-of-life assessment
Location
Contra Costa Regional Medical Center
Martinez
California
United States
94553
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00377130
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Disease Management
A broad approach to appropriate coordination of the entire disease treatment process that often involves shifting away from more expensive inpatient and acute care to areas such as preventive medicine, patient counseling and education, and outpatient care. This concept includes implications of appropriate versus inappropriate therapy on the overall cost and clinical outcome of a particular disease. (From Hosp Pharm 1995 Jul;30(7):596)
Multivariate Analysis
A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.
Genetic Counseling
An educational process that provides information and advice to individuals or families about a genetic condition that may affect them. The purpose is to help individuals make informed decisions about marriage, reproduction, and other health management issues based on information about the genetic disease, the available diagnostic tests, and management programs. Psychosocial support is usually offered.
Recreation Therapy
The enhancement of physical, cognitive, emotional and social skills so an individual may participate in chosen activities. Recreational modalities are used in designed intervention strategies, incorporating individual's interests to make the therapy process meaningful and relevant.
Directive Counseling
Counseling during which a professional plays an active role in a client's or patient's decision making by offering advice, guidance, and/or recommendations.
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