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Brain and Central Nervous System TumorsNCT00376818

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

A study testing exercise intervention, educational intervention and physiologic testing in people with Brain and Central Nervous System Tumors and Psychosocial Effects of Cancer and Its Treatment, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
exercise intervention, educational intervention and physiologic testing
How many people
4 participants
Where
1 siteUnited States
Study dates
Jun 2006to Apr 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
exercise intervention, educational intervention, physiologic testing, management of therapy complications, mind-body intervention procedure
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
Medical subject headings
Central Nervous System Neoplasms, Astrocytoma, Ependymoma, Oligodendroglioma, Glioblastoma, Gliosarcoma, Medulloblastoma, Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise interventionBehavioural

    Also called Yoga

    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.

  • educational interventionOther

    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 testingOther

    Also called questionnaire

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

  • management of therapy complicationsOther

    Also called questionnaire

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

  • mind-body intervention procedureBehavioural

    Also called Meditation

    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.

  • Measurement of stress-related hormonesProcedure or surgery

    Also called salivary samples

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months

Secondary outcomes (2)

  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

    Measured: 12 months

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionApr 2008
  4. Study completionApr 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376818
Sponsor's protocol ID
CASE2306
Other IDs
P30CA043703
Status last verified
Jun 2012
First submitted
13 Sep 2006
Last updated
4 Jun 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing exercise intervention, educational intervention and physiologic testing in people with Brain and Central Nervous System Tumors and Psychosocial Effects of Cancer and Its Treatment, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00376818.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2012.

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