Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
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Purpose
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 | Intervention |
|---|---|
|
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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 4 |
| Study Start Date: | June 2006 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
-
Behavioral: exercise intervention
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | Glen H. J. Stevens, DO, PhD | The Cleveland Clinic |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00376818 History of Changes |
| Other Study ID Numbers: | CASE2306, P30CA043703 |
| Study First Received: | September 13, 2006 |
| Last Updated: | June 1, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Case Comprehensive Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms by Site Neoplasms Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013