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


N/A
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Evaluation of a Stress Reduction Program in 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

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

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Glen H. J. Stevens, DO, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Federal Government

Study ID:

CASE2306

NCT ID:

NCT00376818

Start Date:

June 2006

Completion Date:

April 2008

Related Keywords:

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

Name

Location

Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195