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

NCT06747533 | Active Not Recruiting

• 2 other identifiers: 2024-1120NCI-2024-10404
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breathing, Mouth

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events

  Through study completion; an average of 1 year

Study Arms (2)

Standard Patient Education

EXPERIMENTAL

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

Other: CT simulation

Breathe Radiation Protocol Coaching group

EXPERIMENTAL

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

Interventions

CT simulation OTHER

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

Breathe Radiation Protocol Coaching group; Standard Patient Education

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Mouth Breathing

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Mitchell

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 24, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

US (1)