Clinical trial · Interventional
Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
Evaluation of a Stress Reduction Program in Patients With Malignant Brain Tumors and Their Family Caregivers
NCT00376818CI-TRIAL-00007052completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| educational intervention | Other | — | UNRESOLVED |
| exercise intervention | Behavioral | — | UNRESOLVED |
| management of therapy complications | Other | — | UNRESOLVED |
| Measurement of stress-related hormones | Procedure | — | UNRESOLVED |
| mind-body intervention procedure | Behavioral | — | UNRESOLVED |
| physiologic testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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 (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.