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

Not Applicable

Completed

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

• Registration Number: NCT00376818
• Lead Sponsor: Case Comprehensive Cancer Center

Brief 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.

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-09-13
• Study First Submitted QC: 2006-09-13
• Study First Posted: 2006-09-15
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-01
• Last Update Posted: 2012-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples	12 months
Decrease in perception of stress and anxiety in patients and their primary family caregivers as measured by the Perceived Stress Scale and Beck Anxiety Inventory questionnaires	12 months

Trial Locations

Locations (1)

Cleveland Clinic Taussig Cancer Center; 🇺🇸 Cleveland, Ohio, United States