Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00376818

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 Cancer-Related Problem/Condition	Procedure: educational intervention Procedure: exercise intervention Procedure: management of therapy complications Procedure: manipulative and body-based intervention procedure Procedure: mind-body intervention procedure Procedure: physiologic testing Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

MedlinePlus related topics: Brain Cancer Cancer Caregivers Exercise and Physical Fitness

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care
Official Title:	Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment:	28
Study Start Date:	June 2006
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376818

Locations

United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Glen H. J. Stevens, DO, PhD

The Cleveland Clinic

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000495071, CASE-CCF-2306-CC052, CASE-2306
Study First Received:	September 13, 2006
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00376818
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

psychosocial effects/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

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Central Nervous System Diseases
Stress
Central Nervous System Neoplasms
Brain Diseases
Ependymoma
Recurrence

Brain Neoplasms
Medulloblastoma
Oligodendroglioma
Meningioma
Glioma
Gliosarcoma
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009