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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Meditation Intervention | Experimental |
| |
| Standard of Care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rachel Kingsford | Contact | 801-585-0115 | rachel.kingsford@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lindsay Burt, MD | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 7 weeks |
| 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 |
| 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 |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |