Back to resultsStress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Primary Purpose
Brain and Central Nervous System Tumors, Psychosocial Effects of Cancer and Its Treatment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
exercise intervention
educational intervention
physiologic testing
management of therapy complications
mind-body intervention procedure
Measurement of stress-related hormones
Sponsored by
About this trial
This is an interventional supportive care trial for Brain and Central Nervous System Tumors focused on measuring psychosocial effects of cancer and its treatment, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult medulloblastoma, adult anaplastic meningioma, adult papillary meningioma, adult mixed glioma, recurrent adult brain tumor, adult glioblastoma, adult grade III meningioma
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant brain tumor of 1 of the following subtypes:
- Anaplastic astrocytoma
- Glioblastoma multiforme
- Astrocytoma WHO grade IV
- Malignant meningioma
- Anaplastic oligodendroglioma
- Anaplastic oligoastrocytoma
- Gliosarcoma
- Anaplastic ependymoma
- Medulloblastoma
Caregivers must meet the following criteria:
- Primary family caregiver
- Age 18 and over
PATIENT CHARACTERISTICS:
- Karnofsky performance status 70-100%*
- Absolute neutrophil count ≥ 1,500/mm³*
- Platelet count ≥ 100,000/mm³*
- Bilirubin ≤ 2 times normal*
- Alkaline phosphatase ≤ 2 times normal*
- SGOT ≤ 3 times normal*
- BUN or creatinine ≤ 1.5 times normal*
- No other prior (within the past 3 years) or concurrent malignancies except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer*
- Not pregnant**
- Negative pregnancy test**
- Fertile patients must use effective contraception**
- No active infection**
- No medical condition that would interfere with the practice of yoga and meditation** NOTE: *Patient
NOTE: **Patient and caregiver
PRIOR CONCURRENT THERAPY:
- No other prior or concurrent stress reduction techniques using yoga or meditation*
- Concurrent standard or investigational chemotherapy, hormonal therapy, immunotherapy, biologic agents, or other complementary and alternative therapies as the primary or adjuvant treatment allowed (patient)
- No concurrent glucocorticoids (caregiver)
- Concurrent dexamethasone allowed provided the daily dose is < 2 mg/day (patient)
- No concurrent dehydroepiandrosterone sulfate (DHEAS) and/or melatonin supplements* NOTE: *Patient and caregiver
Sites / Locations
- Cleveland Clinic Taussig Cancer Center
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples
Full Information
NCT ID
NCT00376818
First Posted
September 13, 2006
Last Updated
June 1, 2012
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00376818
Brief Title
Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Official Title
Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Psychosocial Effects of Cancer and Its Treatment
Keywords
psychosocial effects of cancer and its treatment, adult anaplastic astrocytoma, adult anaplastic ependymoma, adult anaplastic oligodendroglioma, adult giant cell glioblastoma, adult gliosarcoma, adult medulloblastoma, adult anaplastic meningioma, adult papillary meningioma, adult mixed glioma, recurrent adult brain tumor, adult glioblastoma, adult grade III meningioma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
exercise intervention
Other Intervention Name(s)
Yoga
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
educational intervention
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
physiologic testing
Other Intervention Name(s)
questionnaire
Intervention Description
Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.
Intervention Type
Other
Intervention Name(s)
management of therapy complications
Other Intervention Name(s)
questionnaire
Intervention Description
Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.
Intervention Type
Behavioral
Intervention Name(s)
mind-body intervention procedure
Other Intervention Name(s)
Meditation
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Measurement of stress-related hormones
Other Intervention Name(s)
salivary samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed malignant brain tumor of 1 of the following subtypes:
Anaplastic astrocytoma
Glioblastoma multiforme
Astrocytoma WHO grade IV
Malignant meningioma
Anaplastic oligodendroglioma
Anaplastic oligoastrocytoma
Gliosarcoma
Anaplastic ependymoma
Medulloblastoma
Caregivers must meet the following criteria:
Primary family caregiver
Age 18 and over
PATIENT CHARACTERISTICS:
Karnofsky performance status 70-100%*
Absolute neutrophil count ≥ 1,500/mm³*
Platelet count ≥ 100,000/mm³*
Bilirubin ≤ 2 times normal*
Alkaline phosphatase ≤ 2 times normal*
SGOT ≤ 3 times normal*
BUN or creatinine ≤ 1.5 times normal*
No other prior (within the past 3 years) or concurrent malignancies except for surgically cured carcinoma in situ of the cervix or nonmelanoma skin cancer*
Not pregnant**
Negative pregnancy test**
Fertile patients must use effective contraception**
No active infection**
No medical condition that would interfere with the practice of yoga and meditation** NOTE: *Patient
NOTE: **Patient and caregiver
PRIOR CONCURRENT THERAPY:
No other prior or concurrent stress reduction techniques using yoga or meditation*
Concurrent standard or investigational chemotherapy, hormonal therapy, immunotherapy, biologic agents, or other complementary and alternative therapies as the primary or adjuvant treatment allowed (patient)
No concurrent glucocorticoids (caregiver)
Concurrent dexamethasone allowed provided the daily dose is < 2 mg/day (patient)
No concurrent dehydroepiandrosterone sulfate (DHEAS) and/or melatonin supplements* NOTE: *Patient and caregiver
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glen H. J. Stevens, DO, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
We'll reach out to this number within 24 hrs