NCT04303013
Completed
Phase 3
A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Quality of Life
- Sponsor
- Mayo Clinic
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Effectiveness of Meditation Sessions
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Kimberly S. Corbin
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Prescribed a course of RT with fewer than 15 consecutive, daily fractions
- •Unable or unwilling to attend required MBI sessions
Outcomes
Primary Outcomes
Effectiveness of Meditation Sessions
Time Frame: 3 months and 12 months post radiation treatment.
Comparison of change in FACT-G, Promis 10 and LASA-6 surveys.
Study Sites (1)
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