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

• ClinicalTrials.gov Identifier: NCT00376818
• Recruitment Status: Completed
• First Posted: September 15, 2006
• Last Update Posted: June 4, 2012
• Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Brain and Central Nervous System Tumors; Psychosocial Effects of Cancer and Its Treatment	Behavioral: exercise intervention; Other: educational intervention; Other: physiologic testing; Other: management of therapy complications; Behavioral: mind-body intervention procedure; Procedure: Measurement of stress-related hormones	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
• Study Start Date: June 2006
• Actual Primary Completion Date: April 2008
• Actual Study Completion Date: April 2008

Arms and Interventions

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 12 months ]

Secondary Outcome Measures :

1. 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 ]
2. Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples [ Time Frame: 12 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

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

More Information

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00376818
• Other Study ID Numbers: CASE2306; P30CA043703 ( U.S. NIH Grant/Contract )
• First Posted: September 15, 2006
• Last Update Posted: June 4, 2012
• Last Verified: June 2012

Keywords provided by Case Comprehensive Cancer Center:

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

Additional relevant MeSH terms:

Brain Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs