Guided Meditation During Radiation Therapy for Brain Tumors

NCT06165653 | Recruiting DMC

• 1 other identifier: HCI167297
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  7 weeks

Secondary Outcomes (3)

• 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

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

  7 weeks

• 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

Study Arms (2)

Guided Meditation Intervention

EXPERIMENTAL

Behavioral: 10 to 15-Minute, Audio-Recorded Guided Mediation Practice

Standard of Care

NO INTERVENTION

Interventions

10 to 15-Minute, Audio-Recorded Guided Mediation Practice BEHAVIORAL

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

Guided Meditation Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Lindsay Burt, MD

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Kingsford

CONTACT

801-585-0115; rachel.kingsford@hci.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2023
• First Posted: December 11, 2023
• Study Start: February 29, 2024
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)