Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
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|ClinicalTrials.gov Identifier: NCT00376818|
Recruitment Status : Completed
First Posted : September 15, 2006
Last Update Posted : June 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Psychosocial Effects of Cancer and Its Treatment||Behavioral: exercise intervention Other: educational intervention Other: physiologic testing Other: management of therapy complications Behavioral: mind-body intervention procedure Procedure: Measurement of stress-related hormones||Not Applicable|
- Determine whether regular practice of a stress reduction program for 8 weeks improves the quality of life of patients with malignant brain tumors.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
- 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 Name: Yoga
- 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 Name: questionnaire
- Other: management of therapy complications
Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.Other Name: questionnaire
- 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.Other Name: Meditation
- 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.Other Name: salivary samples
- 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 [ Time Frame: 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 [ Time Frame: 12 months ]
- Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00376818
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Glen H. J. Stevens, DO, PhD||The Cleveland Clinic|