Status:
COMPLETED
Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Brain and Central Nervous System Tumors
Psychosocial Effects of Cancer and Its Treatment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Yoga, meditation, and breathing exercises may help lower stress and improve quality of life in patients with malignant brain tumors and their family caregivers. PURPOSE: This clinical tria...
Detailed Description
OBJECTIVES: Primary * Determine whether regular practice of a stress reduction program for 8 weeks improves the quality of life of patients with malignant brain tumors. Secondary * Determine wheth...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant brain tumor of 1 of the following subtypes:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Astrocytoma WHO grade IV
- Malignant meningioma
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Gliosarcoma
- Anaplastic ependymoma
- Medulloblastoma
- Caregivers must meet the following criteria:
- Primary family caregiver
- Age 18 and over
- PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%\*
- Absolute neutrophil count ≥ 1,500/mm³\*
- Platelet count ≥ 100,000/mm³\*
- Bilirubin ≤ 2 times normal\*
- Alkaline phosphatase ≤ 2 times normal\*
- SGOT ≤ 3 times normal\*
- BUN or creatinine ≤ 1.5 times normal\*
- No other prior (within the past 3 years) or concurrent malignancies except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer\*
- Not pregnant\*\*
- Negative pregnancy test\*\*
- Fertile patients must use effective contraception\*\*
- No active infection\*\*
- No medical condition that would interfere with the practice of yoga and meditation\*\* NOTE: \*Patient
- NOTE: \*\*Patient and caregiver
- PRIOR CONCURRENT THERAPY:
- No other prior or concurrent stress reduction techniques using yoga or meditation\*
- Concurrent standard or investigational chemotherapy, hormonal therapy, immunotherapy, biologic agents, or other complementary and alternative therapies as the primary or adjuvant treatment allowed (patient)
- No concurrent glucocorticoids (caregiver)
- Concurrent dexamethasone allowed provided the daily dose is \< 2 mg/day (patient)
- No concurrent dehydroepiandrosterone sulfate (DHEAS) and/or melatonin supplements\* NOTE: \*Patient and caregiver
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00376818
Start Date
June 1 2006
End Date
April 1 2008
Last Update
June 4 2012
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195