Clinical trial NCT00376818: Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Official title: Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain and Central Nervous System Tumors
Psychosocial Effects of Cancer and Its Treatment
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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-09-15
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
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
timeFrame: 12 months
Secondary outcomes:
measure: 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
timeFrame: 12 months
measure: Decrease in stress- and inflammation-related hormones in patients and their primary family caregivers as measured by saliva samples
timeFrame: 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Taussig Cancer Center
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Glen H. J. Stevens, DO, PhD
role: PRINCIPAL_INVESTIGATOR
References: