Skip to main content
OpenTrials
Completed

NCT Number: NCT04303013

Guided Meditation 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Quality of Life Cancer Neoplasms Radiation Injuries Radiation Toxicity Relaxation During Radiation Therapy Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditation

Behavioral

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.

Standard of care

Other

Patient not assigned to meditation will undergo radiation with usual care and complete quality of life surveys before, during and after treatment.

Primary outcomes

  1. 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.

  2. Effectiveness of Meditation Sessions

    Time frame: During radiation treatment

    Comparison of change in total LASA-6 and single question relaxation surveys.

  3. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2020
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.