Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
NCT Number: NCT00376818
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cleveland, Ohio, 44195, United States
OBJECTIVES:
Primary
Secondary
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
NOTE: **Patient and caregiver
PRIOR CONCURRENT THERAPY:
All participants will convene once per week for 8 weeks for a 90-minute session that will be based on yoga principles for a stress reduction.
Other names: Yoga
A 15-minute educational session on a particular topic (mind-body connection; fight or flight response; relaxation response; the science and philosophy of yoga; the science of meditation; sleeping well; mindfulness; the healer within - how to harness your innate healing potential).
Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.
Other names: questionnaire
Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.
Other names: questionnaire
Meditation practice in this study will consist of 15 minutes of "body scan" to completely relax the body from head to toe and will be followed by 15 minute silence during which the study participants will maintain awareness of their breath, bodily sensations and thoughts as they spontaneously arise. The remainder of the class will be devoted to a group discussion of personal reflections and challenges.
Other names: Meditation
Measurements of stress-related hormones: Stress hormones cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin will be measured in saliva because their levels in saliva accurately reflect blood levels (Carlson et al, 2004). The non-invasive saliva collection method by cotton swabs (Salivette® by Sardstedt Inc.) will be used in this study.
Other names: salivary samples
Time frame: 12 months
Time frame: 12 months
Time frame: 12 months
Case Comprehensive Cancer Center
Other
Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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