Trial Information

Stress Management Training For Patients Undergoing Radiotherapy

OBJECTIVES:

Primary

- Determine whether a modified version of a self-administered stress management training
intervention, previously found to be of benefit in chemotherapy patients, is effective
in improving quality of life and decreasing psychological distress (anxiety and
depression) in patients with cancer who are undergoing radiotherapy.

Secondary

- Compare the efficacy of this intervention on improving quality of life and decreasing
psychological distress (anxiety and depression) in male vs female patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I: Patients receive self-administered stress management training (SSMT) in 3 stress
management techniques (progressive muscle relaxation training and guided imagery,
abdominal breathing, and coping skills) adapted specifically for use during
radiotherapy. Patients initially receive a 5-minute standardized presentation regarding
the nature and purpose of SSMT. Patients then receive information and instruction
regarding the three stress management techniques comprising a videotape, audiotape, and
brochure. Patients also receive their institution's usual psychosocial care.

- Arm II: Patients receive their institution's usual psychosocial care only. Quality of
life, anxiety, and depression are assessed at baseline and then at 1, 2, and 3 weeks.
Intervention helpfulness is assessed at 3 weeks.

PROJECTED ACCRUAL: A total of 327 patients (approximately 163 per treatment arm) will be
accrued for this study within 2 years.