Guided Meditation During Radiotherapy.

Phase 3

Completed

• Conditions: Quality of Life; Relaxation During Radiation Therapy; Cancer; Radiation Toxicity

• Registration Number: NCT04303013
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Study First Submitted: 2020-02-26
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-10
• Primary Completion: 2023-03-27
• Study Completion: 2023-03-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness of Meditation Sessions	3 months and 12 months post radiation treatment.	Comparison of change in FACT-G, Promis 10 and LASA-6 surveys.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States