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Completed

NCT Number: NCT00376818

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: questionnaire

management of therapy complications

Other

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

Other names: 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.

Other names: 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.

Other names: salivary samples

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

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2006
Registry last updated
Jun 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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