Audiovisual biofeedback breathing guidance for lung cancer patients receiving
radiotherapy: a multi-institutional phase II randomised clinical trial.
Author(s): Pollock S(1), O'Brien R(2), Makhija K(3), Hegi-Johnson F(4), Ludbrook J(5), Rezo
A(6), Tse R(7), Eade T(8), Yeghiaian-Alvandi R(9,)(10), Gebski V(11), Keall
PJ(12).
Affiliation(s): Author information:
(1)Radiation Physics Laboratory, Sydney Medical School, The University of Sydney,
Sydney, NSW, Australia. sean.pollock@sydney.edu.au. (2)Radiation Physics
Laboratory, Sydney Medical School, The University of Sydney, Sydney, NSW,
Australia. ricky.obrien@sydney.edu.au. (3)Radiation Physics Laboratory, Sydney
Medical School, The University of Sydney, Sydney, NSW, Australia.
kuldeep.makhija@sydney.edu.au. (4)Central Coast Cancer Centre, Gosford Hospital,
Gosford, NSW, Australia. Fiona.HegiJohnson@health.nsw.gov.au. (5)Department of
Radiation Oncology, Calvary Mater Newcastle, Newcastle, NSW, Australia.
Jane.Ludbrook@calvarymater.org.au. (6)Department of Radiation Oncology, Canberra
Hospital, Canberra, ACT, Australia. angela.rezo@act.gov.au. (7)Department of
Radiation Oncology, Chris O'Brien Lifehouse, Sydney, NSW, Australia.
Regina.Tse@lh.org.au. (8)Department of Radiation Oncology, Northern Sydney Cancer
Centre, Sydney, NSW, Australia. TEade@nsccahs.health.nsw.gov.au. (9)Radiation
Oncology Network, Crown Princess Mary Cancer Centre, Westmead Hospital, Sydney,
NSW, Australia. roland.Alvandi@swahs.health.nsw.gov.au. (10)Department of
Radiation Oncology, Nepean Cancer Care Centre, Sydney, NSW, Australia.
roland.Alvandi@swahs.health.nsw.gov.au. (11)University of Sydney NHMRC Clinical
Trials Centre, Sydney, NSW, Australia. val.gebski@ctc.usyd.edu.au. (12)Radiation
Physics Laboratory, Sydney Medical School, The University of Sydney, Sydney, NSW,
Australia. paul.keall@sydney.edu.au.
Publication date & source: 2015, BMC Cancer. , 15:526
BACKGROUND: There is a clear link between irregular breathing and errors in
medical imaging and radiation treatment. The audiovisual biofeedback system is an
advanced form of respiratory guidance that has previously demonstrated to
facilitate regular patient breathing. The clinical benefits of audiovisual
biofeedback will be investigated in an upcoming multi-institutional, randomised,
and stratified clinical trial recruiting a total of 75 lung cancer patients
undergoing radiation therapy.
METHODS/DESIGN: To comprehensively perform a clinical evaluation of the
audiovisual biofeedback system, a multi-institutional study will be performed.
Our methodological framework will be based on the widely used Technology
Acceptance Model, which gives qualitative scales for two specific variables,
perceived usefulness and perceived ease of use, which are fundamental
determinants for user acceptance. A total of 75 lung cancer patients will be
recruited across seven radiation oncology departments across Australia. Patients
will be randomised in a 2:1 ratio, with 2/3 of the patients being recruited into
the intervention arm and 1/3 in the control arm. 2:1 randomisation is appropriate
as within the interventional arm there is a screening procedure where only
patients whose breathing is more regular with audiovisual biofeedback will
continue to use this system for their imaging and treatment procedures. Patients
within the intervention arm whose free breathing is more regular than audiovisual
biofeedback in the screen procedure will remain in the intervention arm of the
study but their imaging and treatment procedures will be performed without
audiovisual biofeedback. Patients will also be stratified by treating institution
and for treatment intent (palliative vs. radical) to ensure similar balance in
the arms across the sites. Patients and hospital staff operating the audiovisual
biofeedback system will complete questionnaires to assess their experience with
audiovisual biofeedback. The objectives of this clinical trial is to assess the
impact of audiovisual biofeedback on breathing motion, the patient experience and
clinical confidence in the system, clinical workflow, treatment margins, and
toxicity outcomes.
DISCUSSION: This clinical trial marks an important milestone in breathing
guidance studies as it will be the first randomised, controlled trial providing
the most comprehensive evaluation of the clinical impact of breathing guidance on
cancer radiation therapy to date. This study is powered to determine the impact
of AV biofeedback on breathing regularity and medical image quality. Objectives
such as determining the indications and contra-indications for the use of AV
biofeedback, evaluation of patient experience, radiation toxicity occurrence and
severity, and clinician confidence will shed light on the design of future phase
III clinical trials.
TRIAL REGISTRATION: This trial has been registered with the Australian New
Zealand Clinical Trials Registry (ANZCTR), its trial ID is ACTRN12613001177741 .
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