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

May 19, 2026 updated by: M.D. Anderson Cancer Center
To learn if coaching participants on diaphragmatic breathing will help participants to take larger, more reproducible breaths and feel less anxiety about their treatments.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Women over the age of 18 with invasive breast cancer requiring radiation to the left whole breast or treatment of either the right or left breast/chestwall with comprehensive nodal irradiation will be eligible for study. These are the participants with the highest risk of cardiac exposure. Forty participants total are expected to be enrolled on the study, with an estimate of 3-4 participants enrolled per week. We anticipate the study will be able to accrue 40 participants within 3 months based on average treatment numbers in the MDACC Mays clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standard Patient Education
If participants are in the Standard Participants Education group, participants will receive standard of care participants education.
Other: CT simulation
Given by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction.
Experimental: 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.
Other: CT simulation
Given by lung function test (spirometry) and questionnaire about treatment anxiety and satisfaction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Adverse Events
Time Frame: Through study completion; an average of 1 year
Through study completion; an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Melissa Mitchell, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

December 24, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-1120
  • NCI-2024-10404 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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