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Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00376818
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Case Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Glen H. J. Stevens, DO, PhD
Principal Investigator Affiliation The Cleveland Clinic
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Psychosocial Effects of Cancer and Its Treatment
Additional Details

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 whether regular practice of a stress reduction routine decreases perception of stress and anxiety and stress- and inflammation-related hormones in both patients with malignant brain tumors and their primary family caregivers.
OUTLINE: This is a pilot study. Patients and caregivers receive a 90-minute stress-reduction session once a week for 8 weeks. Each session comprises an educational session on stress reduction and yoga therapy comprising specific yoga postures, breathing exercises, and relaxation and meditation. Quality of life, stress, anxiety, and levels of stress-related hormones (cortisol, dehydroepiandrosterone sulfate [DHEAS], and melatonin) are assessed at baseline and at week 8. After completion of study treatment, patients and caregivers are followed at 6 and 12 months. PROJECTED ACCRUAL: A total of 14 caregiver/patient pairs will be accrued for this study.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195

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