Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001055392p
Ethics application status
Help: Ethics application status
Submitted, not yet approved
Date submitted
Help: Date submitted
14/07/2026
Date registered
Help: Date registered
26/08/2026
Date last updated
Help: Date last updated
26/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
26/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing an app-based breathing exercise program with standard breathing exercises in preparing breast cancer patients for breath-hold radiation therapy
Scientific title
A pilot randomised controlled trial assessing the feasibility and acceptability of a breathwork exercise program delivered via Physitrack, and its preliminary effects compared with standard departmental education, in patients undergoing deep inspiration breath hold radiotherapy.
Additional trial identifiers [1] 317913 0
nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
respiratory limitations 342858 0
breast cancer 343377 0
Condition category
Condition code
Cancer 338979 338979 0 0
Breast
Respiratory 338980 338980 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
What is the intervention?
The intervention is a structured breathwork exercise program delivered through the Physitrack mobile application. The program uses exercises selected from the existing Physitrack exercise library to improve diaphragmatic breathing, respiratory control, and breath-hold performance in preparation for Deep Inspiration Breath Hold (DIBH) radiation therapy. Examples of these exercises include: diaphragmatic breathing, bilateral shoulder flexion with breathing, thoracic expansion, abdominal breathing and box breathing.
The comparison group will receive the breath-hold exercises routinely provided as part of standard departmental education.
Who delivers it and their relevant expertise?
The exercise program will be prescribed by a Senior Exercise Physiologist with expertise in respiratory exercise prescription. The program will then be set up for the participant, who received the Physitrack arm, in the Physitrack application by the healthcare professional from the research team. The healthcare professional will either be the radiation therapist or radiation oncology nurse who obtained consent from the participant. This team member will also provide the participant with instructions on accessing and using the application.
How is it delivered?
The intervention is delivered individually through the Physitrack application. Participants receive video demonstrations, written instructions, exercise reminders, and adherence monitoring through the application. Participants allocated to the control arm receive standard departmental education and written instructions describing the breath-hold exercises.
How often and for how long?
Participants will complete the prescribed exercises twice daily for approximately two weeks before their CT simulation/planning appointment. Each session takes less than 10 minutes to complete and consists of four progressively challenging diaphragmatic breathing and breath-hold exercises designed to prepare patients for DIBH radiation therapy.
Where is it delivered?
Participants will be introduced to the intervention following their initial consultation with their radiation oncologist at the North Coast Cancer Institute, Lismore Base Hospital. The exercise program is then completed independently in the participant's home using the Physitrack application (intervention arm) or written exercise instructions (control arm).

Adherence
Participants allocated to the Physitrack arm will receive automated exercise reminders through the application, and adherence will be monitored using app-recorded exercise completion data. Both arm participants will record their exercise completion in a paper diary, which will be collected at their CT simulation appointment.
Intervention code [1] 334759 0
Treatment: Other
Intervention code [2] 334760 0
Behaviour
Intervention code [3] 334761 0
Lifestyle
Description of the comparator or control
What is the comparator?
The comparator is the breath-hold exercises routinely provided as part of standard departmental education for patients preparing for Deep Inspiration Breath Hold (DIBH) radiation therapy. These exercises are provided in written format and represent current clinical practice at Lismore Base Hospital. Our current clinical guideline for breath-hold exercises is breathing in and holding this breath while in the supine position for up to 30 seconds.

Who delivers it and their relevant expertise?
The written exercise program is provided by a member of the research team who is also a qualified healthcare professional (radiation therapist or radiation oncology clinical nurse specialist) and has obtained the participant's consent. These clinicians are experienced in preparing patients for DIBH radiation therapy.

How is it delivered?
The comparator is delivered individually as written educational material describing the prescribed breath-hold exercises. Participants receive verbal instruction on how to perform the exercises and are encouraged to ask questions.

How often and for how long?
Participants will be asked to complete the prescribed exercises twice daily for approximately two weeks, from enrolment until their CT simulation/planning appointment. Each exercise session takes less than 10 minutes to complete.

Where is it delivered?
Participants receive the written exercise instructions during their appointment at Lismore Base Hospital and complete the exercises independently in their own home.

Adherence
Participants in the comparator arm will record completion of their prescribed exercises in a paper diary throughout the intervention period. The diary will be collected by the research team at the participant's CT simulation/planning appointment.
Control group
Active

Outcomes
Primary outcome [1] 346213 0
Feasibility of recruitment and retention - these will be assessed as a composite outcome
Timepoint [1] 346213 0
Throughout recruitment and at completion of the post-intervention assessment
Primary outcome [2] 346214 0
Intervention adherence
Timepoint [2] 346214 0
Throughout the intervention period, from enrolment until the day before computed tomography simulation
Primary outcome [3] 346215 0
Participant acceptability
Timepoint [3] 346215 0
Following completion of the intervention and prior to computed tomography simulation
Secondary outcome [1] 465030 0
Inspiratory capacity
Timepoint [1] 465030 0
At baseline and after the intervention, prior to computed tomography simulation
Secondary outcome [2] 465031 0
Breath-hold stability
Timepoint [2] 465031 0
At baseline and after the intervention, prior to computed tomography simulation
Secondary outcome [3] 465032 0
Deep inspiration breath hold capability
Timepoint [3] 465032 0
At computed tomography simulation

Eligibility
Key inclusion criteria
Patients with a diagnosis of cancer who have been offered Deep Inspiration Breath Hold (DIBH) radiation therapy.
Unable to achieve or maintain adequate DIBH during the initial screening assessment due to respiratory-related limitations, verified using the department's respiratory monitoring system.
Able to provide informed written consent.
Able to commence the intervention at least one week before their computed tomography simulation/planning appointment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Able to achieve and maintain adequate deep inspiration breath hold during the initial screening assessment.
Unable to perform deep inspiration breath hold for reasons unrelated to respiratory limitations, such as pain, anxiety, or difficulty maintaining the treatment position.
Medical contraindication to undertaking the prescribed breathing exercises.
Unable to understand the study materials or use the Physitrack program without appropriate language support.
Less than one week between consent and the computed tomography simulation/planning appointment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be prepared in advance by members of the academic research team who are not involved in participant recruitment or consent. Group assignments will be placed in sequentially numbered, opaque, sealed envelopes. After a participant has provided written informed consent and been enrolled in the study, the next envelope in sequence will be opened to reveal the assigned study arm. This process will conceal allocation from the recruiting researcher until enrolment is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
nil
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/09/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
16/07/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29852 0
Lismore Base Hospital - Lismore
Recruitment postcode(s) [1] 46207 0
2480 - Lismore

Funding & Sponsors
Funding source category [1] 322449 0
Other
Name [1] 322449 0
Northern NSW Academic Health Alliance
Country [1] 322449 0
Australia
Primary sponsor type
Government body
Name
Northern NSW Local Health District
Address
Country
Australia
Secondary sponsor category [1] 325377 0
None
Name [1] 325377 0
Address [1] 325377 0
Country [1] 325377 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 320940 0
North Coast NSW Human Research Ethics Committee
Ethics committee address [1] 320940 0
Ethics committee country [1] 320940 0
Australia
Date submitted for ethics approval [1] 320940 0
26/03/2026
Approval date [1] 320940 0
Ethics approval number [1] 320940 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152146 0
Ms Kathleene Dower
Address 152146 0
North Coast Cancer Institute, 70-72 Hunter Street Lismore NSW 2480
Country 152146 0
Australia
Phone 152146 0
+61 266294315
Fax 152146 0
Email 152146 0
[email protected]
Contact person for public queries
Name 152147 0
Kathleene Dower
Address 152147 0
North Coast Cancer Institute, 70-72 Hunter Street Lismore NSW 2480
Country 152147 0
Australia
Phone 152147 0
+61 266294315
Fax 152147 0
Email 152147 0
[email protected]
Contact person for scientific queries
Name 152148 0
Kathleene Dower
Address 152148 0
North Coast Cancer Institute, 70-72 Hunter Street Lismore NSW 2480
Country 152148 0
Australia
Phone 152148 0
+61 266294315
Fax 152148 0
Email 152148 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be shared to protect participant confidentiality. Aggregate, de-identified results will be disseminated through publications and conference presentations.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.