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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Brain and Central Nervous System Tumors; Psychosocial Effects of Cancer and Its Treatment

Treatments: Procedure: Measurement of stress-related hormones; Behavioral: mind-body intervention procedure; Other: management of therapy complications; Other: physiologic testing; Other: educational intervention; Behavioral: exercise intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00376818

CASE2306

P30CA043703 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)