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

NCT ID: NCT00376818

Last Updated: 2012-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2008-04-30

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.

Conditions

Brain and Central Nervous System Tumors; Psychosocial Effects of Cancer and Its Treatment

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

exercise intervention

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: BEHAVIORAL

educational intervention

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

physiologic testing

Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.

Intervention Type: OTHER

management of therapy complications

Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.

Intervention Type: OTHER

mind-body intervention procedure

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: BEHAVIORAL

Measurement of stress-related hormones

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.

Intervention Type: PROCEDURE

Other Intervention Names

Yoga; questionnaire; questionnaire; Meditation; salivary samples

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glen H. J. Stevens, DO, PhD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE2306

Identifier Type: -

Identifier Source: org_study_id