NCT00376818

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

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 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.

Conditions

• Brain and Central Nervous System Tumors
• Psychosocial Effects of Cancer and Its Treatment

Interventions

Type	Name	Description
BEHAVIORAL	exercise intervention	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	educational intervention	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).
OTHER	physiologic testing	Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.
OTHER	management of therapy complications	Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.
BEHAVIORAL	mind-body intervention procedure	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.
PROCEDURE	Measurement of stress-related hormones	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.

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-09-15
• Last updated: 2012-06-04

Locations

1 site across 1 country: United States