Stress Management Training in Patients Undergoing Radiation Therapy for Cancer - Full Text View

Sponsors and Collaborators:	H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00057733

Purpose

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	Intervention
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific	Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

MedlinePlus related topics: Anxiety Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Active Control
Official Title:	Stress Management Training For Patients Undergoing Radiotherapy

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:	February 2003
Primary Completion Date:	April 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057733

Locations

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

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Paul Jacobsen, PhD

H. Lee Moffitt Cancer Center and Research Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069466, MCC-0108, NCI-5721, NCI-P02-0227, TAGH-20291
Study First Received:	April 7, 2003
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00057733
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

quality of life
anxiety disorder
depression
unspecified adult solid tumor, protocol specific

Study placed in the following topic categories:

Depression
Anxiety Disorders
Quality of Life
Stress
Depressive Disorder

ClinicalTrials.gov processed this record on January 16, 2009