NCT06165653 Guided Meditation During Radiation Therapy for Brain Tumors
| NCT ID | NCT06165653 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Utah |
| Condition | Brain Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-02-29 |
| Primary Completion | 2027-01-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors. The main question it aims to answer is: • What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions? Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.
Eligibility Criteria
Inclusion Criteria: * Participant aged ≥ 18 years. * Radiologically confirmed tumor of the brain. Note: Participants may have tumor resected after diagnosis. * Eligible to undergo radiation treatment for brain tumor for 25-33 treatments. * Willing to participate in either the guided meditation or standard of care control arm, regardless of treatment assignment. * Karnofsky performance score ≥ 60 or ECOG performance score ≤ 2. * MoCA mini score ≥ 11 * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Active suicidal ideation or active psychotic state in the opinion of the investigator. * An unstable illness that, in the opinion of the investigator, would interfere with study treatment. * Prior radiation therapy to the brain. * Inability to understand and/or speak the English language.