Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Stress Management Training in Patients Undergoing Radiation Therapy for Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Educational/Counseling/Training | Completed | 18 and over | NCI | MCC-0108 NCI-5721, NCI-P02-0227, TAGH-20291, NCT00057733 |
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.
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
- Prostate seed implants allowed
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
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
Expected Enrollment
A total of 327 patients (approximately 163 per treatment arm) will be accrued for this study within 2 years.
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.
Trial Lead Organizations
SunCoast CCOP Research Base at the University of South Florida
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| Paul Jacobsen, PhD, Protocol chair | |
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| Registry Information | ||
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| Official Title | Stress Management Training For Patients Undergoing Radiotherapy | |
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| Trial Start Date | 2003-02-18 | |
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| Trial Completion Date | 2005-04-18 | |
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| Registered in ClinicalTrials.gov | NCT00057733 | |
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| Date Submitted to PDQ | 2002-06-03 | |
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| Information Last Verified | 2005-04-27 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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