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Guided Meditation During Radiotherapy.

A Randomized Controlled Trial of Guided Mindfulness Intervention During Radiotherapy.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04303013
Enrollment
75
Registered
2020-03-10
Start date
2019-06-01
Completion date
2023-03-27
Last updated
2023-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Quality of Life, Radiation Toxicity, Relaxation During Radiation Therapy

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.

Interventions

BEHAVIORALMeditation

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.

OTHERStandard of Care

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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of Meditation SessionsBefore radiation treatment.including emotional, physical, functional, and social domains assessed via the FACT-G during and after radiotherapy for the treatment of cancer.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026