Guided Meditation During Radiation Therapy for Brain Tumors

Official title

An Interventional Trial Using Guided Meditation During Radiation Therapy for Brain Tumors

Overview

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.

Interventions

• Behavioral 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"

Primary outcome measures

• 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]

Secondary outcome measures (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 [Time frame: 7 weeks]
• Change in anxiety during RT and in everyday life as measured by the modified MPoD [Time frame: 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.) [Time frame: 7 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Huntsman Cancer Institute — Salt Lake City

Identifiers

NCT: NCT06165653 · HCI167297

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗