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

Brain and Central Nervous System Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00376818
• Other study ID #: CASE2306
• Secondary ID: P30CA043703
• Status: Completed
• Phase: N/A
• First received: September 13, 2006
• Last updated: June 1, 2012
• Start date: June 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2012
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• 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.

Other:
• 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).
• physiologic testing
Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.
• management of therapy complications
Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.

Behavioral:
• 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.

Procedure:
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples		12 months	No