Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057733
Recruitment Status : Completed
First Posted : April 9, 2003
Last Update Posted : May 30, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Anxiety Disorder Depression Unspecified Adult Solid Tumor, Protocol Specific Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Not Applicable

Detailed Description:



  • 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.


  • 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 Type : Interventional  (Clinical Trial)
Allocation: Randomized
Official Title: Stress Management Training For Patients Undergoing Radiotherapy
Study Start Date : February 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : June 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Able to read and speak English


Biologic therapy

  • Not specified


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

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy


  • Not specified

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057733

United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, California
CCOP - Bay Area Tumor Institute
Oakland, California, United States, 94609-3305
United States, District of Columbia
Howard University Cancer Center at Howard University Hospital
Washington, District of Columbia, United States, 20060
MBCCOP - Howard University Cancer Center
Washington, District of Columbia, United States, 20060
United States, Florida
Comprehensive Cancer Care Center at Bethesda Memorial Hospital
Boynton Beach, Florida, United States, 33435
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Cancer Care and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65807
United States, New York
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, United States, 10466
United States, Ohio
CCOP - Columbus
Columbus, Ohio, United States, 43206
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Washington
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
Sponsors and Collaborators
University of South Florida
National Cancer Institute (NCI)
Study Chair: Paul Jacobsen, PhD University of South Florida Identifier: NCT00057733     History of Changes
Other Study ID Numbers: MCC-0108
CDR0000069466 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 9, 2003    Key Record Dates
Last Update Posted: May 30, 2013
Last Verified: April 2005

Keywords provided by National Cancer Institute (NCI):
anxiety disorder
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Anxiety Disorders
Behavioral Symptoms
Mental Disorders