Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Breathe Well
* Device: RPM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Left-sided breast cancer patients (invasive and in situ) 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: Involvement or at risk regional lymph nodes Pregnant / lactating women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breathe Well + RPM<br>Participants will receive Breathe Well audiovisual feedback in addition to the RPM system | Device: Breathe Well<br>* Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.<br>Device: RPM<br>* Varian Real-time Position Management (RPM) system<br>|
| Active Comparator: RPM<br>Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run. | Device: RPM<br>* Varian Real-time Position Management (RPM) system<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DIBH, breast cancer, radiation, cardiac toxicity