Recruiting

Mindfulness during RT

Sponsor:

University of Utah

Code:

NCT06165653

Conditions

Brain Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT06165653

Start date

Feb 29, 2024

Status verified date

Mar, 2026

Completion date

Jan 15, 2028

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Guided Meditation Intervention

no intervention: Standard of Care

Interventions

10 to 15-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

Primary outcome measure

  • 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. [ Time Frame: 7 weeks ]

Central Contacts and Locations

Central contacts

Rachel Kingsford

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

Locations

Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Rachel Kingsford

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

More Information

Sponsor

University of Utah

Last update posted

Mar 20, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Utah on 2026-03-20.