Guided Meditation During Radiotherapy.

NCT ID: NCT04303013

Last Updated: 2023-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2023-03-27

Brief Summary

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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.

Detailed Description

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Conditions

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Quality of Life Relaxation During Radiation Therapy Cancer Radiation Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

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

Meditation

Group Type EXPERIMENTAL

Meditation

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Kimberly S. Corbin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kimberly S. Corbin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-02757

Identifier Type: REGISTRY

Identifier Source: secondary_id

18-004546

Identifier Type: -

Identifier Source: org_study_id

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