Guided Meditation During Radiotherapy.

October 30, 2023 updated by: Kimberly S. Corbin, Mayo Clinic

A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Other: Standard of Care
Patient not assigned to meditation will undergo radiation with usual care and complete quality of life surveys before, during and after treatment.
Experimental: Meditation
Behavioral: Meditation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of Meditation Sessions
Time Frame: Before radiation treatment.
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
Time Frame: During radiation treatment
Comparison of change in total LASA-6 and single question relaxation surveys.
During radiation treatment
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.
3 months and 12 months post radiation treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Kimberly S. Corbin, M.D., Mayo Clinic in Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

March 27, 2023

Study Completion (Actual)

March 27, 2023

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 10, 2020

Study Record Updates

Last Update Posted (Actual)

November 1, 2023

Last Update Submitted That Met QC Criteria

October 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 18-004546
  • NCI-2021-02757 (Registry Identifier: CTRP (Clinical Trials Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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