Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

Not Applicable

Completed

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

• Registration Number: NCT00057733
• Lead Sponsor: University of South Florida

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2003-04-07
• Study First Submitted QC: 2003-04-08
• Study First Posted: 2003-04-09
• Status Verified: 2005-04
• Primary Completion: 2005-04
• Study Completion: 2006-06
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (12)

CCOP - Cancer Research for the Ozarks; 🇺🇸 Springfield, Missouri, United States

CCOP - Western Regional, Arizona; 🇺🇸 Phoenix, Arizona, United States

Cancer Care and Research Pavilion at St. Joseph's/Candler; 🇺🇸 Savannah, Georgia, United States

CCOP - Northwest; 🇺🇸 Tacoma, Washington, United States

CCOP - Scott and White Hospital; 🇺🇸 Temple, Texas, United States

CCOP - Columbus; 🇺🇸 Columbus, Ohio, United States

CCOP - Bay Area Tumor Institute; 🇺🇸 Oakland, California, United States

MBCCOP - Howard University Cancer Center; 🇺🇸 Washington, District of Columbia, United States

Howard University Cancer Center at Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States

Comprehensive Cancer Care Center at Bethesda Memorial Hospital; 🇺🇸 Boynton Beach, Florida, United States

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida; 🇺🇸 Tampa, Florida, United States

MBCCOP-Our Lady of Mercy Cancer Center; 🇺🇸 Bronx, New York, United States