Guided Meditation During Radiotherapy.
A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
2 other identifiers
interventional
75
1 country
1
Brief Summary
The purpose of this research is to gather information on the effects of Mindfulness-Based Intervention (MBI) on quality of life during and after radiation treatment. This study involves randomization. There is a 50 percent chance (like a flip of the coin) that you will be randomized to attend meditation sessions during treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 quality-of-life
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2023
CompletedNovember 1, 2023
August 1, 2023
3.8 years
February 26, 2020
October 30, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Effectiveness of Meditation Sessions
including emotional, physical, functional, and social domains assessed via the FACT-G during and after radiotherapy for the treatment of cancer.
Before radiation treatment.
Effectiveness of Meditation Sessions
Comparison of change in total LASA-6 and single question relaxation surveys.
During radiation treatment
Effectiveness of Meditation Sessions
Comparison of change in FACT-G, Promis 10 and LASA-6 surveys.
3 months and 12 months post radiation treatment.
Study Arms (2)
Standard of Care
ACTIVE COMPARATORMeditation
EXPERIMENTALInterventions
Patients will attend weekly in person guided meditation sessions during the course of their radiation treatment. Patient will complete quality of life surveys before, during and after treatment.
Patient not assigned to meditation will undergo radiation with usual care and complete quality of life surveys before, during and after treatment.
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Prescribed a course of at least 15 daily fractions of RT for curative intent of any malignancy
- Willing to attend MBI sessions weekly during RT
- Able to transport themselves to scheduled MBI sessions in the DAHLC
- Able to complete questionnaire(s) by themselves
- Native English speaker (MBI sessions, videos, and QOL questionnaires are only available in English)
- ECOG Performance Status 0-2
You may not qualify if:
- Prescribed a course of RT with fewer than 15 consecutive, daily fractions
- Unable or unwilling to attend required MBI sessions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimberly S. Corbin, M.D.
Mayo Clinic in Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 26, 2020
First Posted
March 10, 2020
Study Start
June 1, 2019
Primary Completion
March 27, 2023
Study Completion
March 27, 2023
Last Updated
November 1, 2023
Record last verified: 2023-08