Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001020976
Ethics application status
Approved
Date submitted
30/07/2020
Date registered
7/10/2020
Date last updated
2/02/2022
Date data sharing statement initially provided
7/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
SMARTscreen: A randomised controlled trial to measure the impact of SMS messages sent to patients from their general practice on participation in the National Bowel Cancer Screening Program.
Scientific title
A cluster randomised controlled trial to determine the effect of patient SMS narrative messaging in general practice on the participation of adults aged 50 - 60 years in the the National Bowel Cancer Screening Program in Victoria
Secondary ID [1] 301867 0
CPSRG19018
Universal Trial Number (UTN)
U1111-1256-0157
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 318364 0
Condition category
Condition code
Cancer 316382 316382 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a SMS personalised message from the general practice sent to the patient's smartphone with links to:
1. A message from the general practitioners (GPs) at the general practice (e.g. Hello. xxx
This is a health message from the GPs at xxx Medical Practice.
Your free bowel cancer screening kit will arrive in the post soon.
We strongly encourage you to do this test. If cancer is detected early over 90% of bowel cancers are successfully treated. We recommend that you watch the videos below.)

2. A video of a person talking about their positive experience of doing the National Bowel Cancer Screening Program (NBCSP) Immunochemical Faecal Occult Blood Test (IFOBT) test
3. A animated video demonstrating how to complete the test
4. Links to information from Cancer Council Australia
The SMS is sent from the general practice one month prior to patients 50th, 52nd, 54th, 56th, 58th and 60th birthdays. The intervention period is six months long, there will be 6 rounds of SMS sent during that time to any active patient due to receive their NBCSP kit. Patients will only receive one SMS. The number of patients due to be sent the SMS will be recorded in PEN CAT4 clinical audit software and the number of SMS sent is recorded on the GoShare Plus platform. Data, the number of patients due to receive the SMS and the number of SMS sent is recorded at the general practice. This data is collected by the project manager.
Intervention code [1] 318158 0
Early detection / Screening
Intervention code [2] 318159 0
Prevention
Comparator / control treatment
standard care. Standard care is defined as usual care. Patients will not not receive any additional information about the National Bowel Screening Program.
Control group
Active

Outcomes
Primary outcome [1] 324564 0
The primary outcome will be the proportion of patients who complete the NBCSP after six months from the total number of eligible patients who are about to have their 50th, 52nd, 54th, 56th, 58th, or 60th birthdays. This outcome will be measured by the number of FOBT results sent to the general practice for patients in this age group. Aggregate data (number of FOBTs returned in each age group) will be collected from the electronic medical records.
Timepoint [1] 324564 0
From commencement of the 6 month intervention period to 6 months after completion of the intervention period.
Secondary outcome [1] 386409 0
Process measures will include whether the SMS is open and the number of times the links in the SMS are open. this is recorded on the Go Share Plus platform in the CAT4 clinical audit tool. tool. This aggregated data will be collected at the general practice.
Timepoint [1] 386409 0
From the commencement of the six month intervention to six months after the intervention period finishes.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. A general practice located in the Western Victorian Primary Health Network region
2. A general practice that uses electronic medical records compatible with Pen CS CAT4 clinical audit software and the GoShare Plus platform
3. Has at least 2 full time equivalent GPs
4. Has a staff member willing to send out the SMS bundles to patients
5. General practices where GPs are willing for eligible patients aged 50 - 60 years due to receive the NBCSP kit also receive the SMS intervention
6. General practice patients aged 50 -60 years with no previous history of bowel cancer eligible to receive the NBCSP kit.
Minimum age
50 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who will not receive the SMS intervention:
1. Those who do not have a smart phone
2. Those who do not have their mobile phone number recorded at their general practice
3. Those who have opted out of any messaging communication from their general practice
4. Those aged 50 to 60 years who are not eligible to receive a National Bowel Cancer Screening kit during the intervention period.

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)
Each general practice is a cluster and will be randomised to either a control or intervention arm.
All general practices will be notified of their randomisation allocation due to the nature of the intervention. A computer generated allocation will be undertaken off site at a central location.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The unit of randomisation (cluster) is the general practice. Randomisation to either the control or intervention group will be done using a computer generated random sequence with 1:1 ratio. Randomisation will use a minimisation approach, maximising the balance across baseline variables. Baseline data will be collected from all general practices recruited to the trial prior to randomisation and we will stratify according by size of general practice (No of GP FTE) and location (regional city or regional town)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will recruit 20 general practices (10 intervention and 10 control ) in to this study. We will require 1400 patients (70 per general practice) to provide 80% power with two-sided 5% significance level to detect a 10% increase in National Bowel Cancer Screening Program participation in the intervention arm compared to the control arm (50% vs 40%). The estimates are based on average general practice population size, assuming an intra-cluster correlation of 0.008

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2020
Actual
18/01/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
30/07/2021
Date of last data collection
Anticipated
31/12/2021
Actual
31/12/2021
Sample size
Target
1400
Accrual to date
Final
2745
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 306289 0
Government body
Name [1] 306289 0
Department of Health and Human Services
Country [1] 306289 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Centre for Cancer Research
Faculty of Medicine, Dentistry and Health Sciences
University of Melbourne
Level 10, Victorian Comprehensive Cancer Centre
305 Grattan St,
Melbourne
Victoria 3000 Australia
Country
Australia
Secondary sponsor category [1] 306783 0
University
Name [1] 306783 0
Monash University
Address [1] 306783 0
Monash University
Faculty of Information Technology
Monash University Building 79P,
7 Innovation Walk
Clayton VIC 3800
Australia
Country [1] 306783 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306506 0
University of Melbourne Medical and Dentistry Human Ethics Sub- Committee
Ethics committee address [1] 306506 0
Ethics committee country [1] 306506 0
Australia
Date submitted for ethics approval [1] 306506 0
10/06/2020
Approval date [1] 306506 0
29/06/2020
Ethics approval number [1] 306506 0
2057042.1

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

Contacts
Principal investigator
Name 104094 0
Prof Jon Emery
Address 104094 0
Centre for Cancer Research
Faculty of Medicine, Dentistry and Health Sciences
University of Melbourne
Level 10, Victorian Comprehensive Cancer Centre
305 Grattan Street,
Melbourne
Victoria 3000 Australia
Country 104094 0
Australia
Phone 104094 0
+61 3 85597044
Fax 104094 0
Email 104094 0
[email protected]
Contact person for public queries
Name 104095 0
Jennifer McIntosh
Address 104095 0
Monash University
Faculty of Information Technology
Monash University
Building 79P, 7 Innovation Walk
Clayton VIC 3800
Australia
Country 104095 0
Australia
Phone 104095 0
+61 408 510 248
Fax 104095 0
Email 104095 0
[email protected]
Contact person for scientific queries
Name 104096 0
Jennifer McIntosh
Address 104096 0
Monash University
Faculty of Information Technology
Monash University
Building 79P, 7 Innovation Walk
Clayton VIC 3800
Australia
Country 104096 0
Australia
Phone 104096 0
+61 408 510 248
Fax 104096 0
Email 104096 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
EmbaseThe SMARTscreen Trial: a randomised controlled trial investigating the efficacy of a GP-endorsed narrative SMS to increase participation in the Australian National Bowel Cancer Screening Program.2022https://dx.doi.org/10.1186/s13063-021-05877-3
N.B. These documents automatically identified may not have been verified by the study sponsor.