Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers

June 1, 2012 updated by: Case Comprehensive Cancer Center

Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	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	12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Glen H. J. Stevens, DO, PhD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)