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

NCT00376818 | Completed DMC

• 2 other identifiers: CASE2306P30CA043703
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (2)

• 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

  12 months

• Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples

  12 months

Interventions

exercise intervention BEHAVIORAL

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.

Also known as: Yoga

educational intervention OTHER

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).

physiologic testing OTHER

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

Also known as: questionnaire

management of therapy complications OTHER

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

Also known as: questionnaire

mind-body intervention procedure BEHAVIORAL

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.

Also known as: Meditation

Measurement of stress-related hormones PROCEDURE

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.

Also known as: salivary samples

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Astrocytoma; Ependymoma; Oligodendroglioma; Glioblastoma; Gliosarcoma; Medulloblastoma; Meningioma; Glioma; Brain Neoplasms

Interventions

Yoga; Early Intervention, Educational; Surveys and Questionnaires; Mind-Body Therapies; Meditation

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neoplasms, Vascular Tissue; Meningeal Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities; Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Glen H. J. Stevens, DO, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2006
• First Posted: September 15, 2006
• Study Start: June 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 4, 2012

Record last verified: 2012-06

Locations

US (1)