Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000007932
Ethics application status
Approved
Date submitted
14/01/2019
Date registered
8/01/2020
Date last updated
28/06/2021
Date data sharing statement initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
SMARTphone-Based Cardiovascular Risk Reduction Program in BREAST Cancer Patients [SMART-BREAST]: A Multi-Centre Randomized Controlled Trial
Scientific title
Smartphone Based Cardiovascular Risk Reduction Program in Patients Undergoing Treatment for Breast Cancer
Secondary ID [1] 297062 0
None
Universal Trial Number (UTN)
Trial acronym
SMART-BREAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
 311063 0
Breast Cancer 311064 0
Condition category
Condition code
Cardiovascular 309700 309700 0 0
Other cardiovascular diseases
Cancer 309701 309701 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive standard of care treatment for their breast cancer. This includes inpatient and outpatient oncology review as required, planning and prescription of chemotherapy, radiotherapy, targeted therapy or hormone therapy as appropriate and promotion of self-care with access to the Breast Cancer Network Australia resources during cancer treatment.
Eligible patients will be randomized in a 1:1 fashion to a smartphone-based cardiovascular risk reduction program or usual care alone. Randomization will be stratified by study site and will be overseen by the Centre of Cardiovascular Research and Education in Therapeutics; an independent research body within the School of Public Health and Preventive Medicine at Monash University (Melbourne, Australia). Assessors of the primary outcomes are blind to treatment allocation; however, participants are not blinded.
The smartphone-based cardiovascular risk reduction program will be delivered over 12 months, starting at the beginning of cancer treatment through a smartphone app. Participants in the smartphone intervention cohort will download the intervention app into their smartphone. They will then receive education on how to use the app. The program is a multi-faceted intervention with particular emphasis on physical activity. The app provides a platform for comprehensive assessment of cardiovascular risk factors and utilizes a ‘traffic light’ system to represent target achievement. ‘High Risk’ parameters are displayed in red, ‘Suboptimal’ parameters are displayed in yellow and ‘On Target’ parameters are displayed in green. Participants will receive a notification if a risk factor parameter is not on target. Non-pharmacological and pharmacological treatment of risk factors will be prescribed according to the National Heart Foundation Secondary Prevention Guidelines[18] with up titration of medications until target parameters have been achieved.
The different components are discussed in detail below:
Dynamic tracking of cardiovascular risk factors - Patients will have an interactive personal dashboard highlighting the status of their cardiovascular risk factors. They will be graded depending whether they are at recommended target levels.
Exercise Prescription - Patients will have access to real-time feedback of their activity levels through the app’s activity tracker which links to the iphone’s accelerometer feature. Patients will be able to monitor the number of steps taken and the distance walked. Feedback will be provided through messaging services.
Dietary Habits - Dietary habits will be tracked through the app via access to the phone’s inbuilt camera. Participants will be encouraged to take photos of the food they are eating to keep record of their diet. They will have capabilities to rate and comment on the food.
Interactive and Personalized Feedback - Patients will receive personalized messages via the app messaging service providing feedback on risk factor control and physical activity.
Support - The messaging service also allows the patient to initiate contact if they have any questions regarding their cardiac condition. Replies will be made within one working day.

Participants will be evaluated at baseline and at 12 months. Baseline assessment will include the following measurements: height, weight, waist circumference, resting heart rate and blood pressure, smoking status, fasting cholesterol and glucose levels.
Intervention code [1] 313335 0
Lifestyle
Intervention code [2] 313336 0
Prevention
Comparator / control treatment
Standard of care. This includes access to the treating cancer service's health and wellbeing programs which encourage regular exercise.
Control group
Active

Outcomes
Primary outcome [1] 318664 0
The primary outcome is a change in exercise capacity (measured by six-minute walk test distance).
Timepoint [1] 318664 0
12 months
Secondary outcome [1] 365619 0
Cardiovascular risk factor profile (Composite secondary outcome):
a. Change in blood pressure (mmHg)
- Tested with manual blood pressure cuff measurement.
b. Change in lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides)
- Tested with serum assay
c. Change in fasting glucose levels and HbA1C
- Tested with serum assay
d. Smoking status assessed by self-reporting
- Ascertained by patient reporting
e. Change in weight and body mass index (BMI)
- Anthropometry measurements performed at 12 month follow up to calculate BMI.



3. Incidence of venous thromboembolism (VTE)

4. Quality of life as measured by the SF-36 questionairre
Timepoint [1] 365619 0
Baseline and 12 months post enrollment
Secondary outcome [2] 365752 0
Major adverse cardiovascular events (composite of death, myocardial infarction, stroke, unplanned revascularization)
Timepoint [2] 365752 0
12 months post enrollment
Secondary outcome [3] 365753 0
Change in quality of life assessed by SF-36 questionnaire.
Timepoint [3] 365753 0
12 months post enrollment
Secondary outcome [4] 376975 0
Incidence of venous thromboembolism
- Ascertained by patient reporting
Timepoint [4] 376975 0
12 months post enrollment
Secondary outcome [5] 378330 0
Received dose intensity of chemotherapy (RDI)
- This is calculated by the delivered dose/standard dose x100
Timepoint [5] 378330 0
12 months post enrollment

Eligibility
Key inclusion criteria
Patients over the age of 18 with a diagnosis of breast cancer treated with any modality. The other major inclusion criteria will be personal ownership of a smartphone.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with metastatic disease and patients with a prognosis of less than 6 months as determined by their treating oncologist at the time of diagnosis. Patients who are unable to give informed consent, cannot communicate in written English will also be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
Statistical analyses will be performed using SPSS (IBM, USA). Baseline characteristics will be summarized using descriptive statistics. Continuous variables will be described as mean and standard deviation and be compared using Student’s t test. Categorical variables will be described as frequencies and percentages and compared using Fisher’s exact or chi-square tests as appropriate.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
4/02/2020
Actual
1/06/2020
Date of last participant enrolment
Anticipated
4/02/2021
Actual
1/06/2021
Date of last data collection
Anticipated
4/02/2022
Actual
Sample size
Target
100
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12877 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 19814 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [3] 19815 0
Epworth Richmond - Richmond
Recruitment hospital [4] 19816 0
Warringal Private Hospital - Heidelberg
Recruitment postcode(s) [1] 25355 0
3084 - Heidelberg
Recruitment postcode(s) [2] 34502 0
3550 - Bendigo
Recruitment postcode(s) [3] 34503 0
3121 - Richmond
Recruitment postcode(s) [4] 34504 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301632 0
Hospital
Name [1] 301632 0
Austin Health
Country [1] 301632 0
Australia
Primary sponsor type
Hospital
Name
Cardiology Department - Austin Health
Address
Austin Health
Cardiology Department
Level 5
Studley Rd
Heidelberg 3084
Victoria
Country
Australia
Secondary sponsor category [1] 301339 0
None
Name [1] 301339 0
Address [1] 301339 0
Country [1] 301339 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302355 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302355 0
Ethics committee country [1] 302355 0
Australia
Date submitted for ethics approval [1] 302355 0
01/08/2019
Approval date [1] 302355 0
01/10/2019
Ethics approval number [1] 302355 0
HREC/47081/Austin-2018

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

Contacts
Principal investigator
Name 89938 0
Dr Matias Yudi
Address 89938 0
Austin Health Cardiology Department
Level 5
145 Studley Rd
Heidelberg
Victoria 3084
Country 89938 0
Australia
Phone 89938 0
+61 3 94965000
Fax 89938 0
Email 89938 0
[email protected]
Contact person for public queries
Name 89939 0
Alexandra Murphy
Address 89939 0
Austin Health Cardiology Department
Level 5
145 Studley Rd
Heidelberg
Victoria 3084
Country 89939 0
Australia
Phone 89939 0
+61 411790262
Fax 89939 0
Email 89939 0
[email protected]
Contact person for scientific queries
Name 89940 0
Alexandra Murphy
Address 89940 0
Austin Health Cardiology Department
Level 5
145 Studley Rd
Heidelberg
Victoria 3084
Country 89940 0
Australia
Phone 89940 0
+61 411790262
Fax 89940 0
Email 89940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSMARTphone Based Cardiovascular Risk Reduction in BREAST Cancer Patients (SMART-BREAST): A Randomised Controlled Trial Protocol.2021https://dx.doi.org/10.1016/j.hlc.2021.03.271
EmbaseRandomized Controlled Trial of a Smartphone-Based Intervention to Enhance 6-Minute Walk Distance during Breast Cancer Treatment: The SMART-BREAST Trial.2023https://dx.doi.org/10.1161/CIRCULATIONAHA.122.062946
N.B. These documents automatically identified may not have been verified by the study sponsor.