Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
NCT ID: NCT02881203
Last Updated: 2023-07-27
Study Results
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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COMPLETED
NA
45 participants
INTERVENTIONAL
2018-09-15
2022-09-30
Brief Summary
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Detailed Description
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Breathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Breathe Well + RPM
Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
Breathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
RPM
Varian Real-time Position Management (RPM) system
RPM
Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.
RPM
Varian Real-time Position Management (RPM) system
Interventions
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Breathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
RPM
Varian Real-time Position Management (RPM) system
Eligibility Criteria
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Inclusion Criteria
* Supine positioning of the patients.
* Ability to perform a ≥20s breath hold
* \>18 years old
* An ECOG score in the range of 0 to 2
* Able to give written informed consent and willingness to participate and comply with the study
* Patients must be able to read and complete questionnaires in English
Exclusion Criteria
* Pregnant / lactating women
18 Years
FEMALE
No
Sponsors
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University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Gillian Lamoury, Medicine
Role: PRINCIPAL_INVESTIGATOR
Royal North Shore Hospital
Locations
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Royal North Shore Hospital
St Leonards, New South Wales, Australia
Countries
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References
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Byrne HL, Steiner E, Booth J, Lamoury G, Morgia M, Richardson K, Ambrose L, Makhija K, Stanton C, Zwan B, Bromley R, Atyeo J, Silvester S, Plant N, Keall P. BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy. Trials. 2023 Feb 22;24(1):132. doi: 10.1186/s13063-023-07072-y.
Other Identifiers
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BRAVEHeartV1
Identifier Type: -
Identifier Source: org_study_id
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