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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02881203
Registration number
NCT02881203
Ethics application status
Date submitted
22/08/2016
Date registered
26/08/2016
Titles & IDs
Public title
Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
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Scientific title
BRAVEHeart - Breast Radiotherapy Audio Visual Enhancement for Sparing the Heart
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Secondary ID [1]
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BRAVEHeartV1
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Universal Trial Number (UTN)
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Trial acronym
BRAVEHeart
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Breathe Well
Treatment: Devices - RPM
Experimental: Breathe Well + RPM - Participants will receive Breathe Well audiovisual feedback in addition to the RPM system
Active comparator: RPM - Varian's RPM system is the current standard of care at Royal North Shore Hospital where this trial is to be run.
Treatment: Devices: Breathe Well
Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
Treatment: Devices: RPM
Varian Real-time Position Management (RPM) system
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Accuracy of Breathe Well
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Assessment method [1]
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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).
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Difference in set up times for Breathe Well vs RPM
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Assessment method [1]
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The setup times for both systems, the 'Breathe Well' and the modified RPM system; will be measured for all fractions.
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Patient comfort
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Assessment method [2]
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To investigate patient comfort in using 'Breathe Well' via a patient survey.
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Staff perception of Breathe Well
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Assessment method [3]
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To investigate staff perception of 'Breathe Well' via a technology assessment survey.
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Timepoint [3]
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2 years
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Secondary outcome [4]
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To develop the use of EPID for real time MLC tracking during breast radiotherapy
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Assessment method [4]
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0
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Timepoint [4]
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2 years
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Secondary outcome [5]
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To compare actual and planned doses
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Assessment method [5]
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Using dose reconstruction estimate the dose distribution delivered during radiotherapy and compare this with the planned dose.
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Timepoint [5]
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2 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Involvement or at risk regional lymph nodes
* Pregnant / lactating women
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/09/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2022
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Sample size
Target
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Accrual to date
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Final
45
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal North Shore Hospital - St Leonards
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Recruitment postcode(s) [1]
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2065 - St Leonards
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02881203
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Gillian Lamoury, Medicine
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Address
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Royal North Shore Hospital
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymised data will be made available to researchers upon request, once evidence of ethical approval has been provided.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02881203