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

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Case Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Glen H. J. Stevens, DO, PhD · The Cleveland Clinic

Study Design

Allocation

NA

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2008-04-30

Completion

2008-04-30

Countries

• United States

Study Locations