Guided Meditation During Radiotherapy.

• Sponsor: Mayo Clinic (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04303013
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60.5
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Quality of Life; Relaxation During Radiation Therapy; Cancer; Radiation Toxicity	Behavioral: Meditation; Other: Standard of Care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.
• Actual Study Start Date: Jun 1, 2019
• Anticipated Primary Completion Date: Jun 15, 2023
• Anticipated Study Completion Date: Jun 15, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Effectiveness of Meditation Sessions [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 [During radiation treatment]

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

3. Effectiveness of Meditation Sessions [3 months and 12 months post radiation treatment.]

   Comparison of change in FACT-G, Promis 10 and LASA-6 surveys.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kimberly S. Corbin, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04303013
• Other Study ID Numbers: 18-004546
• First Posted: Mar 10, 2020
• Last Update Posted: Jul 18, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 18, 2022