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Clinical Trials/NCT04303013
NCT04303013
Completed
Phase 3

A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.

Mayo Clinic1 site in 1 country75 target enrollmentJune 1, 2019

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2019
End Date
March 27, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

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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