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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00376818
First received: September 13, 2006
Last updated: June 1, 2012
Last verified: June 2012

September 13, 2006
June 1, 2012
June 2006
April 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00376818 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Brain and Central Nervous System Tumors
  • Psychosocial Effects of Cancer and Its Treatment
  • 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 Name: Yoga
  • 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).
  • Other: physiologic testing
    Both patients and family caregivers will complete Perceived Stress Scale (PSS) and Beck Anxiety Inventory (BAI) questionnaires.
    Other Name: questionnaire
  • Other: management of therapy complications
    Brain Cancer module-20 questionnaire to assesses problems specific to brain tumor.
    Other Name: questionnaire
  • 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.
    Other Name: Meditation
  • 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.
    Other Name: salivary samples
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00376818
CASE2306, P30CA043703
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Glen H. J. Stevens, DO, PhD The Cleveland Clinic
Case Comprehensive Cancer Center
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP