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NCT04303013 Clinical Trial

Guided Meditation During Radiotherapy.

Cancer Clinical Trial

Official title:
A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04303013
Other study ID # 18-004546
Secondary ID NCI-2021-02757
Status Completed
Phase Phase 3
First received
Last updated
Start date June 1, 2019
Est. completion date March 27, 2023

Study information
Verified date August 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date March 27, 2023
Est. primary completion date March 27, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
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.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness of Meditation Sessions including emotional, physical, functional, and social domains assessed via the FACT-G during and after radiotherapy for the treatment of cancer. Before radiation treatment.
Primary Effectiveness of Meditation Sessions Comparison of change in total LASA-6 and single question relaxation surveys. During radiation treatment
Primary Effectiveness of Meditation Sessions Comparison of change in FACT-G, Promis 10 and LASA-6 surveys. 3 months and 12 months post radiation treatment.
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