Guided Meditation During Radiation Therapy for Brain Tumors
- Conditions
- Brain Neoplasms
- Interventions
- Behavioral: 5-Minute, Audio-Recorded Guided Mediation Practice
- Registration Number
- NCT06165653
- Lead Sponsor
- University of Utah
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Guided Meditation Intervention 5-Minute, Audio-Recorded Guided Mediation Practice -
- Primary Outcome Measures
Name Time Method Change in acute anxiety, measured by score on individual item derived from GAD-2, in participants receiving mindfulness intervention during RT compared to standard of care control conditions. 7 weeks To assess the acute anxiolytic effects of a brief mindfulness intervention during RT for brain tumor patients with mask anxiety.
Acute anxiety during RT will be measured each RT visit with an individual item ("How nervous, anxious or on edge do you feel right now?" scored on a 0-10 scale) derived from the Generalized Anxiety Disorder 2-item (GAD-2) scale, "0" meaning "Not at All" and "10" meaning "Very Much") measured before and after RT. The change from before to after RT will be averaged over all RT visits.
- Secondary Outcome Measures
Name Time Method Change in self transcendence and the magnitude/degree of change in self transcendence as measured by total score of the Nondual Awareness Dimensional Assessment (NADA.) 7 weeks To determine whether the brief mindfulness intervention during RT increases brain tumor patients' self transcendence and whether the degree of changes in self transcendence during RT predict decreases in anxiety in daily life.
Change in anxiety in everyday life in participants receiving mindfulness intervention during RT compared to standard of care, measured using the total score of the GAD-2 scale prior to RT 7 weeks To assess the distal anxiolytic effects of a brief mindfulness intervention during RT for brain tumor patients with mask anxiety.
Anxiety in everyday life will be measured using the total score of the Generalized Anxiety Disorder 2-item (GAD-2) scale prior to RT (minumum value 0, maximum value 6, score of 3 or higher considered clinical.) This will be measured once a week during RT.Change in anxiety during RT and in everyday life as measured by the modified MPoD 7 weeks To determine whether the brief mindfulness intervention during RT increases brain tumor patients' state mindfulness and whether the degree of changes in state mindfulness during RT predict decreases in acute anxiety and anxiety in daily life.
Modified Metacognitive Processes of Decentering Scale (MPoD) consists of 4 items scored on a 0-10 scale, "0" meaning "Not at All" and "10" meaning "Very Much".
Trial Locations
- Locations (1)
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States