Trial Information

Stress Management Therapy for Patients Undergoing Chemotherapy

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.