Stress Management Training in Patients Undergoing Radiation Therapy for Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Stress Management Training For Patients Undergoing Radiotherapy

Conditions
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Anxiety Disorder, Depression, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety disorder, depression, unspecified adult solid tumor, protocol specific