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Guided Meditation for Brain Tumors (Med-RT Trial)

N/A

Recruiting

Led By Lindsay Burt, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant aged ≥ 18 years

Eligible to undergo radiation treatment for brain tumor for 25-33 treatments

Must not have

Prior radiation therapy to the brain

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial investigates whether guided meditation during radiation treatment can reduce anxiety in patients with brain tumors.

Who is the study for?

This trial is for adults over 18 with brain tumors who are set to undergo 25-33 radiation treatments. They must have a certain level of physical and cognitive ability, be willing to try guided meditation or just standard care, and able to consent. People with suicidal thoughts, psychosis, unstable illnesses that could affect treatment, previous brain radiation therapy, or those not fluent in English can't join.

What is being tested?

The study tests if a short guided meditation played during each radiation session can reduce anxiety more than the usual care without any intervention. Participants will either receive this mindfulness practice or follow the standard procedure as they go through their scheduled treatments.

What are the potential side effects?

Since the intervention involves only audio-guided meditation practices and no medication or invasive procedures, there are minimal expected side effects. However, individual reactions to relaxation techniques may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am approved for 25-33 radiation treatments for my brain tumor.

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I have a brain tumor confirmed by imaging tests.

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I can care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Change in anxiety during RT and in everyday life as measured by the modified MPoD

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

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.)