Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001557820
Ethics application status
Approved
Date submitted
9/08/2021
Date registered
17/11/2021
Date last updated
30/08/2023
Date data sharing statement initially provided
17/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot Study of the impact of a digitally delivered exercise intervention on heart health among breast cancer survivors
Scientific title
REMOTE– COR-B: Pilot Evaluation of a Remotely delivered Cardio-Oncology Rehabilitation intervention for Breast cancer survivors
Secondary ID [1] 304993 0
UoM Sponsor reference: CT20016
Universal Trial Number (UTN)
U1111-1251-3978
Trial acronym
REMOTE– COR-B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 323153 0
Physical Inactivity 324150 0
Poor cardiorespiratory fitness 324151 0
Cardio-toxicity 324152 0
Condition category
Condition code
Cancer 320724 320724 0 0
Breast
Physical Medicine / Rehabilitation 321628 321628 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Remote-COR-B Intervention is an exercise intervention delivered using REMOTE technologies. Participants can take part anywhere they can access the internet.

The REMOTE- COR-B platform is comprised of a smartphone and wearable sensor (currently compatible with BioHarness 3, Zephyr Technology and the Polar10), and custom-built smartphone and web apps. The platform facilitates remotely supervised aerobic exercise prescription that is delivered, monitored and coached in real-time by a clinical exercise specialist.

The exercise specialists delivering the intervention will be qualified exercise professionals (either accredited exercise physiologists or physiotherapists) with experience and/or training in exercise prescription for cancer patients. All exercise specialists will be given an exercise prescription protocol to follow that will be updated as needed based on weekly check ins with trial staff.

Exercise prescription: Participants will be asked to participate in three remotely monitored aerobic exercise (e.g., walking, cycling) sessions per week for eight weeks with the aim of increasing cardiorespiratory fitness. The length of the session and exercise intensity will be individually tailored based on rate of perceived exertion (RPE, scale 0-10), objectively measured heart rate, medical history and symptoms reported prior to or during the exercise session.

Type: Walking is the preferred aerobic exercise mode but participants can choose other land-based exercise modes if preferred (e.g., cycling, jogging, rowing).

Frequency: There will be three remotely monitored sessions per week for eight weeks.

Duration: A minimum of 20 minutes each session will be completed where possible. The goal duration is 30-60 minutes.

Intensity: Exercise of at least a moderate intensity if advised.

Progression: The exercise principle of progressive overload will be used to facilitate continual improvement. It is recognised that in this setting maintenance of exercise dosage may reflect progression for some (e.g., those experiencing fluctuating, but persistent treatment-related side effects) and that small increments in intensity, load, duration and/or frequency will be used to generate overload as appropriate.

Participants will exercise with their smartphone (GPS enabled) and while wearing a heart rate sensor. The exercise specialist will monitor participants location, heart rate, RPE, and symptoms via a web-based platform, allowing them to provide individualised audio coaching, feedback and social support throughout the monitoring session, which is delivered to participants via earphones to optimise usability.

Outside of real-time interaction, participants receive 1-2 automatically generated push notifications per week containing general exercise education and behaviour change tips (1-4 sentences long). Topics include benefits of exercise for heart health, added benefits of incorporating flexibility and resistance-training exercises into weekly routines, strategies to overcome exercise barriers, increase exercise confidence, exercise enjoyment and develop long lasting exercise habits.

Participants can also review all recorded exercise performance data and set weekly intensity or duration goals (based on heart rate data) if they choose to. This is designed to be a brief task and is optional.

Participants will be considered adherent to the intervention if they complete at least 17 out of the 24 remotely-monitored exercise sessions (i.e., = 70%). This data is captured automatically by the intervention application.

Intervention code [1] 321383 0
Rehabilitation
Intervention code [2] 321384 0
Lifestyle
Intervention code [3] 321385 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328541 0
As embedding tailored exercise prescription into home-based programs is the key objective driving this program of work, the main outcome will be adherence to the tailored exercise sessions. This will be assessed in terms of percentage of exercise sessions completed (out of 24). This data is collected automatically via the heart rate sensor and the intervention application.
Timepoint [1] 328541 0
2 months post-baseline
Secondary outcome [1] 399363 0
Satisfaction with the intervention will be assessed using the 8-item client satisfaction questionnaire
Timepoint [1] 399363 0
2 months post-baseline
Secondary outcome [2] 399364 0
Intervention usability will be assessed using the system usability scale
Timepoint [2] 399364 0
2 months post-baseline
Secondary outcome [3] 399365 0
Safety of the intervention will be assessed based on the frequency and extent of adverse events reported during the cardiopulmonary exercise testing (CPET) sessions, and during each remote-monitoring session.
Timepoint [3] 399365 0
Baseline, 2 months post-baseline and 5 months post-baseline
Secondary outcome [4] 399366 0
physical fitness (Vo2peak) assessed using cardiopulmonary exercise testing (CPET)
The CPET will involve participants exercising on an exercise bike against increasing resistance (workload) allowing gas exchange analysis to measure anaerobic threshold and peak oxygen consumption (VO2peak).
Timepoint [4] 399366 0
Baseline, 2 month post-baseline and five months post-baseline
Secondary outcome [5] 399367 0
Quality of life (38-item FACT-B)
Timepoint [5] 399367 0
Baseline, 2 month post baseline, 5 months post-baseline
Secondary outcome [6] 399368 0
Fatigue (FACIT)
Timepoint [6] 399368 0
Baseline, 2 months post-baseline and 5 months post-baseline
Secondary outcome [7] 399369 0
Self-reported physical activity - Godin Leisure-time Exercise Questionnaire
Timepoint [7] 399369 0
Baseline, 2 months post-baseline , 5 months post-baseline
Secondary outcome [8] 426177 0
Physical fitness assessed using the Incremental Shuttle Walk Test (ISWT) where the participant will walk along a 10m flat course, gradually increasing their walking speed. The ISWT has been shown to be moderately correlated with CPET-assessed Vo2peak.
Timepoint [8] 426177 0
Baseline, 2 month post-baseline, 5 months post-baseline

Eligibility
Key inclusion criteria
Participants must meet the following criteria to be included:
• Diagnosed with stage I-III breast cancer
• Be at risk of cardiotoxicity according to pre-determine criteria (taking treatment type and dose, as well as other common cardiovascular disease risk factors into account e.g., age, obesity, comorbidity)
• Have completed primary definitive anticancer therapy within the last 6 months (which may be surgery, radiotherapy or chemotherapy depending on if receiving adjuvant or neo-adjuvant treatment)
• Currently completing less than the REMOTE-COR-B target (target: greater than or equal to 150 minutes of moderate-vigorous intensity aerobic activity per week over 3 sessions or more per week; moderate-vigorous intensity exercise is defined as a score of 13 or above on the Borg Rating of Perceived Exertion (RPE) scale).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 (Fully active, able to carry out pre-disease performance without restriction) – 2(Ambulatory and capable of selfcare but unable to carry out any work activities; up and about more than 50% of waking hours).
• Proficiency with the English language (Able to read and write in English to the extent they can read the information sheet, understand study directions and can meaningfully engage in the intervention).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they meet any of the following criteria:
• Diagnosed with metastatic breast cancer (Stage 4)
• Diagnosed with Recurrent Breast Cancer
• Have a medical condition where exercise or cardiopulmonary exercise testing is contraindicated
• Are unable to provide informed consent
• Are unable to fully participate in study assessments
• Have an implanted cardiac device
• Are participating in another exercise study or exercise program with similar goals
• Are participating in a clinical trial that presents safety or contamination issues for either trial

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We aim to recruit 40 participants over nine months. This is equivalent to approximately 20-30% of the sample size needed in order to be adequately powered (80%) in our future definitive trial to demonstrate non-inferiority in V02 peak changes between groups (p value, 0.05); based on differences observed in our formative work.

This sample size is considered sufficient to test the feasibility of delivering the intervention, and of all other key trial parameters. Notably, with this sample size we will also have reasonable precision for estimating intervention adherence. For example, with n = 40, if the average adherence rate observed in the study is 70%, we can be sure with 95% confidence that the true population proportion is between 56% and 85%; 95%CI is ± 14.2. Given the potential reach of the intervention, and that adherence to current technology-based behaviour change programs is 50% this finding would warrant further investigation.


Data will be presented descriptively where appropriate; this includes for the majority of feasibility and acceptability outcomes, including the primary outcome (i.e., adherence to the intervention) as well as safety outcomes (e.g., number of adverse events, proportion of serious adverse events).

Changes over time in VO2 peak, patient-reported outcomes (quality of life and fatigue) and physical activity behaviour will be examined in exploratory analyses using mixed model repeated measures analyses. Unadjusted and adjusted models will be conducted, with adjustment for the following two baseline covariates in adjusted models: age and treatment pathway (adjuvant versus neo-adjuvant). Both adjusted and unadjusted models, as well as standardised coefficients will be reported with 95% confidence intervals to aid interpretation of clinical significance, rather than relying on p-values only. The unadjusted models will be considered the primary analysis. Choice of modelling link will be informed by residual diagnostics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2023
Actual
15/03/2023
Date of last participant enrolment
Anticipated
27/10/2023
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20164 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 20165 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 34894 0
3050 - Parkville
Recruitment postcode(s) [2] 34895 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 309377 0
Charities/Societies/Foundations
Name [1] 309377 0
National Breast Cancer Foundation
Country [1] 309377 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
161 Barry St, Carlton, VIC, 3053
Country
Australia
Secondary sponsor category [1] 310350 0
None
Name [1] 310350 0
Address [1] 310350 0
Country [1] 310350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309193 0
PETER MACCALLUM CANCER CENTRE HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 309193 0
Ethics committee country [1] 309193 0
Australia
Date submitted for ethics approval [1] 309193 0
27/05/2020
Approval date [1] 309193 0
22/04/2021
Ethics approval number [1] 309193 0
HREC/60412/PMCC

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

Contacts
Principal investigator
Name 113298 0
Dr Camille Short
Address 113298 0
Redmond Barry Building, University of Melbourne, Tin Alley, Parkville, VIC, 3010
Country 113298 0
Australia
Phone 113298 0
+61 408288786
Fax 113298 0
Email 113298 0
camille.short@unimelb.edu.au
Contact person for public queries
Name 113299 0
Camille Short
Address 113299 0
Redmond Barry Building, University of Melbourne, Tin Alley, Parkville, VIC, 3010
Country 113299 0
Australia
Phone 113299 0
+61 408288786
Fax 113299 0
Email 113299 0
camille.short@unimelb.edu.au
Contact person for scientific queries
Name 113300 0
Camille Short
Address 113300 0
Redmond Barry Building, University of Melbourne, Tin Alley, Parkville, VIC, 3010
Country 113300 0
Australia
Phone 113300 0
+61 408288786
Fax 113300 0
Email 113300 0
camille.short@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results
When will data be available (start and end dates)?
Following publication of the data, no end date determined
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator: Camille Short
Camille.short@unimelb.edu.au


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.