Guided Meditation During Radiation Therapy for Brain Tumors

Brain Neoplasms Clinical Trial

— Med-RT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06165653
• Other study ID #: HCI167297
• Status: Recruiting
• Phase: N/A
• Start date: February 29, 2024
• Est. completion date: January 15, 2028

Study information

• Verified date: February 2024
• Source: University of Utah
• Contact: Rachel Kingsford
• Phone: 801-585-0115
• Email: rachel.kingsford[@]hci.utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 15, 2028
• Est. primary completion date: January 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	To assess the distal anxiolytic effects of a brief mindfulness intervention during RT for brain tumor patients with mask anxiety.; Anxiety in everyday life will be measured using the total score of the Generalized Anxiety Disorder 2-item (GAD-2) scale prior to RT (minumum value 0, maximum value 6, score of 3 or higher considered clinical.) This will be measured once a week during RT.	7 weeks
Secondary	Change in anxiety during RT and in everyday life as measured by the modified MPoD	To determine whether the brief mindfulness intervention during RT increases brain tumor patients' state mindfulness and whether the degree of changes in state mindfulness during RT predict decreases in acute anxiety and anxiety in daily life.; Modified Metacognitive Processes of Decentering Scale (MPoD) consists of 4 items scored on a 0-10 scale, "0" meaning "Not at All" and "10" meaning "Very Much".	7 weeks
Secondary	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.)	To determine whether the brief mindfulness intervention during RT increases brain tumor patients' self transcendence and whether the degree of changes in self transcendence during RT predict decreases in anxiety in daily life.	7 weeks