Evidence map›Paper›PMID 36814310›Full record

Trial reportTrials2023

BRAVEHeart: a randomised trial comparing the accuracy of Breathe Well and RPM for deep inspiration breath hold breast cancer radiotherapy.

Hilary L Byrne, Elisabeth Steiner, Jeremy Booth, Gillian Lamoury, Marita Morgia, Kylie Richardson, Leigh Ambrose, Kuldeep Makhija, Cameron Stanton, Benjamin Zwan and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02881203 (BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.1field-weighted citation impact, top 26% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02881203 nacompletednot on this map

BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart

TypeinterventionalSponsorUniversity of SydneyRan2018 to 2022Enrolled45ConditionsBreast CancerArmsBreathe Well, RPM
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 3 institutions in 2 countries.

Hilary L ByrneACRF Image X Institute, School of Health Sciences, The University of Sydney, Sydney, Australia.ORCID http://orcid.org/0000-0001-7023-7976
Elisabeth SteinerLK Wiener Neustadt, Wiener Neustadt, Austria.
Jeremy BoothNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Gillian LamouryNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Marita MorgiaNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Kylie RichardsonNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Leigh AmbroseNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Kuldeep MakhijaACRF Image X Institute, School of Health Sciences, The University of Sydney, Sydney, Australia.
Cameron StantonNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Benjamin ZwanNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Regina BromleyNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
John AtyeoNorthern Sydney Cancer Centre, Royal North Shore Hospital, Sydney, Australia.
Shona SilvesterACRF Image X Institute, School of Health Sciences, The University of Sydney, Sydney, Australia.
Natalie PlantACRF Image X Institute, School of Health Sciences, The University of Sydney, Sydney, Australia.
Paul KeallACRF Image X Institute, School of Health Sciences, The University of Sydney, Sydney, Australia. Paul.Keall@sydney.edu.au.
Royal North Shore Hospital · AUThe University of Sydney · AUFachhochschule Wiener Neustadt · AT

Funding

national breast cancer foundation PS-17-055national health and medical research council APP1073772
6 · The paper itself

Abstract

backgroundDeep inspiration breath hold (DIBH) reduces radiotherapy cardiac dose for left-sided breast cancer patients. The primary aim of the BRAVEHeart (Breast Radiotherapy Audio Visual Enhancement for sparing the Heart) trial is to assess the accuracy and usability of a novel device, Breathe Well, for DIBH guidance for left-sided breast cancer patients. Breathe Well will be compared to an adapted widely available monitoring system, the Real-time Position Management system (RPM).

methodsBRAVEHeart is a single institution prospective randomised trial of two DIBH devices. BRAVEHeart will assess the DIBH accuracy for Breathe Well and RPM during left-sided breast cancer radiotherapy. After informed consent has been obtained, 40 patients will be randomised into two equal groups, the experimental arm (Breathe Well) and the control arm (RPM with in-house modification of an added patient screen). The primary hypothesis of BRAVEHeart is that the accuracy of Breathe Well in maintaining the position of the chest during DIBH is superior to the RPM system. Accuracy will be measured by comparing chest wall motion extracted from images acquired of the treatment field during breast radiotherapy for patients treated using the Breathe Well system and those using the RPM system. DISCUSSION: The Breathe Well device uses a depth camera to monitor the chest surface while the RPM system monitors a block on the patient's abdomen. The hypothesis of this trial is that the chest surface is a better surrogate for the internal chest wall motion used as a measure of treatment accuracy. The Breathe Well device aims to deliver an easy-to-use implementation of surface monitoring. The findings from the study will help inform the technology choice for other centres performing DIBH.

trial registrationClinicalTrials.gov NCT02881203 . Registered on 26 August 2016.

Indexed as

Breast NeoplasmsUnilateral Breast NeoplasmsBreath HoldingFemaleHeartHumansOrgans at RiskProspective StudiesBreast cancerDeep inspiration breath holdMotion monitoringRadiotherapySurface monitoringVisual feedback

Identifiers

PMID36814310
PMCPMC9945402
OpenAlexW4321480452

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.