Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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
Glen H. J. Stevens, DO, PhD
Principal Investigator
The Cleveland Clinic
United States: Federal Government
CASE2306
NCT00376818
June 2006
April 2008
Name | Location |
---|---|
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |