Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

University of South Florida

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Anxiety Disorder; Depression

Treatments: Procedure: quality-of-life assessment; Procedure: psychosocial assessment and care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00057733

NCI-5721

CDR0000069466 (Registry Identifier)

MCC-0108

TAGH-20291

NCI-P02-0227

Details and patient eligibility

About

RATIONALE: Stress management techniques such as muscle relaxation, guided imagery, and abdominal breathing may improve quality of life and decrease emotional distress in patients who are undergoing radiation therapy for cancer.

PURPOSE: Randomized clinical trial to determine the effectiveness of stress management training in helping cancer patients cope with the emotional distress of radiation therapy.

Full description

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer

• Must be scheduled to receive a minimum of 12 radiotherapy treatments over a 21-day period

  • Must not be scheduled to receive CNS irradiation
  • Must not be scheduled to receive radiotherapy as palliative care only
  • Prostate seed implants allowed

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Able to read and speak English

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior chemotherapy
• No concurrent cytotoxic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior radiotherapy

Surgery

• Not specified