Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT00376818
Status:
COMPLETED
Last Update Posted:
2012-06-04
First Post:
2006-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |