Impact of Diaphragmatic Breathing Coaching on Deep Inspiration Breath Hold Reproducibility and Organ Protection

NCT ID: NCT06747533

Last Updated: 2025-11-24

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

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-08

Study Completion Date

2026-12-31

Brief Summary

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To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments.

Detailed Description

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Primary Objectives The primary objective is to compare the average daily shift for participant treatment for participant who have had coaching with https://www.thebreathingclass.com/cancer-center/participant versus participant who had standard clinic teaching.

Conditions

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Breathing, Mouth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard Patient Education

If participants are in the Standard Participants Education group, participants will receive standard of care participants education.

Group Type EXPERIMENTAL

CT simulation

Intervention Type OTHER

Given by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction.

Breathe Radiation Protocol Coaching group

If participants are in the Breathe Radiation Protocol Coaching group, you will have access to a video that helps guide you through a relaxed breath hold for the radiation treatment and also access to a coach for questions about the breathing process during radiation. This coaching will take place in the week before you undergo radiation planning.

Group Type EXPERIMENTAL

CT simulation

Intervention Type OTHER

Given by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction.

Interventions

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CT simulation

Given by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Left sided breast cancer planned for whole breast radiation or any breast cancer requiring treatment of the regional nodes
* Treatment planned at the MDACC Mays Breast Radiation Oncology clinic

Exclusion Criteria

* Underlying lung issues that may limit ability to achieve ideal breath hold (COPD on oxygen, etc)
* Active pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Melissa Mitchell

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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http://www.mdanderson.org

MD Anderson Cancer Center

Other Identifiers

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NCI-2024-10404

Identifier Type: OTHER

Identifier Source: secondary_id

2024-1120

Identifier Type: -

Identifier Source: org_study_id

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