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This study investigates the Breathe Well device to test whether it is superior to the existing treatment standard of the Varian Realtime Position Management (RPM) system in assisting patients with deep inspiration breath hold.
Recent studies have demonstrated an increased risks of cardiac disease in breast cancer radiotherapy patients. For patients diagnosed <50 years old, the risks for cardiovascular diseases/events were increased by 24-82% comparing left and right breast radiotherapy. The deep inspiration breath hold (DIBH) technique addresses this problem by reducing the heart dose by up to half, thus potentially reducing the increased rate of major coronary events by 20%. Providing patients with visual feedback in addition to audio guidance has been demonstrated to improve the reproducibility of the DIBH technique by 95% and stability by 80%.
Breathe Well is a new audiovisual feedback device that may increase the accuracy and workflow of implementing DIBH for breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breathe Well + RPM | Experimental | Participants will receive Breathe Well audiovisual feedback in addition to the RPM system |
|
| RPM | Active Comparator | Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breathe Well | Device | Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Breathe Well | The accuracy will be measured by comparing 'Breathe Well' and RPM measurements with images acquired of the breast during the radiation treatment using an electronic portal imaging device (EPID). | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in set up times for Breathe Well vs RPM | The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions. | 2 years |
| Patient comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gillian Lamoury, Medicine | Royal North Shore Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36814310 | Derived | 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. |
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Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D066126 | Cardiotoxicity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| RPM | Device | Varian Real-time Position Management (RPM) system |
|
To investigate patient comfort in using 'Breathe Well' via a patient survey.
| 2 years |
| Staff perception of Breathe Well | To investigate staff perception of 'Breathe Well' via a technology assessment survey. | 2 years |
| To develop the use of EPID for real time MLC tracking during breast radiotherapy | 2 years |
| To compare actual and planned doses | Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose. | 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |