Guided Meditation During Radiation Therapy for Brain Tumors

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Participant aged ≥ 18 years.

- Radiologically confirmed tumor of the brain.

- 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06165653
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Utah
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lindsay Burt, MD
Principal Investigator Affiliation	Huntsman Cancer Institute/ University of Utah
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Neoplasms

Arms & Interventions

Arms

Experimental: Guided Meditation Intervention

No Intervention: Standard of Care

Interventions

Behavioral: - 5-Minute, Audio-Recorded Guided Mediation Practice

Five different meditation practices will be provided, all of which have been validated in prior research. The Body Scan practice consists of instruction in how to direct non-judgmental attention to different regions of the body The Mindful Breathing practice consists of focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and body sensations The Mindfulness of Discomfort practice consists of instruction in how to "zoom in" to deconstruct discomfort and map each feelings' spatial location, use mindful breathing to "zoom out" and broaden the field of awareness to include neglected sensory elements, and shift attention from unpleasant feelings to neutral/pleasant sensations or experiences The Savoring practice consists of instruction in identifying and amplifying pleasant memories The Loving-Kindness practice consists of instruction in cultivating feeling of warmth and compassion toward the self and others

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Recruiting

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Site Contact

Rachel Kingsford

[email protected]

801-585-0115

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