Brain and Central Nervous System Tumors Clinical Trial
Official title:
Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Verified date | June 2012 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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 trial is studying how well a stress reduction program works to
improve the quality of life of patients with malignant brain tumors and their family
caregivers.
Status | Completed |
Enrollment | 4 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quality of life as measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Items (EORTC QLQ-C30) and Brain Cancer Module-20 | 12 months | No | |
Secondary | Decrease in perception of stress and anxiety in patients and their primary family caregivers as measured by the Perceived Stress Scale and Beck Anxiety Inventory questionnaires | 12 months | No | |
Secondary | Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples | 12 months | No |
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