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Home > "S" Clinical Trials Conditions > Stress Management Training in Patients Undergoing Radiation Therapy for Cancer  Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
For Condition: Anxiety Disorder,Depression,unspecified adult solid tumor, protocol specific,Quality of Life
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , National Cancer Institute (NCI)
Synopsis: 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.
Details: OBJECTIVES: - 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. 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 218 patients (109 per treatment arm) will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 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 - No concurrent cytotoxic chemotherapy Endocrine therapy - Not specified Radiotherapy - See Disease Characteristics - No prior radiotherapy Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PaulJacobsen, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
Comprehensive Cancer Care Center at Bethesda Memorial Hospital *Recruiting*
Boynton Beach, Florida, 33435
United States
Recruiting Eyal Meiri 561-740-3377
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Clement Gwede 813-979-3052
Cancer Care and Research Pavilion at St. Joseph's/Candler *Recruiting*
Savannah, Georgia, 31405
United States
Recruiting Morris Geffen 912-692-2102
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C., District of Columbia, 20060
United States
Recruiting Lucile Adams-Campbell 202-806-7697
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
CCOP - Northwest *Recruiting*
Tacoma, Washington, 98405-0986
United States
Recruiting Lauren Colman 253-403-1461
CCOP - Columbus *Recruiting*
Columbus, Ohio, 43206
United States
Recruiting J. Kuebler 614-488-2118
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Additional Information:
Study ID Numbers: CDR0000069466; NCI-5721,MCC-0108,TAGH-20291,NCI-P02-0227
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057733
Other Quality Of Life Studies:
1. Effects of Therapist Behavior on the Treatment of Depressed Adolescents
2. Treatment of Depression with Massage in HIV
3. Genetics of Recurrent Early-Onset Depression
4. Fluoxetine as a Quit Smoking Aid for Depression-Prone Smokers
5. Standard Follow-up Compared With Extended Follow-up in Treating Patients Who Have Undergone Stem Cell Transplantation for Cancer
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Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
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