Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000036617
Ethics application status
Approved
Date submitted
9/01/2023
Date registered
13/01/2023
Date last updated
26/08/2024
Date data sharing statement initially provided
13/01/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
SMARTERscreen: A randomised controlled trial of the effect of patient SMS with health promotion messaging in general practice on participation in the National Bowel Cancer Screening Program.
Scientific title
SMARTERscreen: A randomised controlled trial of the effect of patient SMS with health promotion messaging in general practice on participation in the National Bowel Cancer Screening Program.
Secondary ID [1] 308590 0
Not Known
Universal Trial Number (UTN)
U1111-1285-9764
Trial acronym
SMARTERscreen
Linked study record
ACTRN12620001020976 is a pilot study for this study.

Health condition
Health condition(s) or problem(s) studied:
Bowel cancer 328457 0
Condition category
Condition code
Cancer 325490 325490 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention arms: Intervention arm 1 is an 'SMS-only' sent from general practice to patients, Intervention arm 2 is an 'SMS-bundle' - an SMS with additional video material sent from general practice to patients. The study is a cluster randomised controlled trial with the cluster unit being individual general practices. The intervention will be sent from general practices using an SMS service 'GoShare' depending on the cluster that the general practice has been randomised into. The SMS-only/SMS-bundle will be sent to eligible patients two weeks prior to when their National Bowel Cancer Screening Program (NBCSP) kit is due to arrive. The participants will only be sent one SMS-only or SMS-bundle.
1. The SMS-only is sent from a patient's general practice is to prompt patients to do the NBCSP kit. The SMS contains a greeting and the patient's first name, general practice name and telephone number, a GP endorsement of the NBCSP and the option to 'opt-out' of receiving future SMS.
The wording in the SMS is: 'Hi [insert patient first name]. Your free bowel cancer screening kit will arrive in the post soon. [insert general practice name] strongly encourages you to do this test. Call us on [insert general practice telephone number] if you have any questions. Reply STOP to opt out'.
2. The SMS-bundle is the SMS as described above, but with an web link to a GP message with the general practice logo and endorsing the NBCSP, a video of relatable people talking about why it is important to do the kit (approx 30 seconds long), an instructional video on how to do the kit (approx 45 seconds long), and a link to more information about the NBCSP.
The wording is: 'Hi [insert patient first name]. Your free bowel cancer screening kit will arrive in the post soon. [insert general practice name] strongly encourages you to do this test. We also recommend you watch these videos [weblink to videos inserted here]. Call us on [insert general practice telephone number] if you have any questions. Reply STOP to opt out'.
The intervention will be conducted from general practice and run for 6 months.
The amount of people who opened the weblink and if they watched the videos will be recorded and we will follow up at a later time (not included in this protocol) with interviews with participants about whether or not they read the message etc. We have qualitative data for the previous pilot about the adherence to the intervention and we have modified the SMS-bundle accordingly - mainly making it shorter and modifying the content.
Intervention code [1] 325040 0
Early detection / Screening
Comparator / control treatment
General practices randomised into the control arm will not send SMS to eligible patients, but continue their standard 'usual care'. Usual care is defined as following the guidelines for bowel cancer screening as defined by the Royal Australian College of General Practitioner Red Book Guidelines for Preventive Activities in General Practice.
Control group
Active

Outcomes
Primary outcome [1] 333342 0
Primary outcome:
The primary outcome will be the difference in the proportion of patients who have a faecal occult blood test (FOBT) result recorded by the National Cancer Screening Register between the control arms and both interventions.
This will be analysed by sex, age and location.
Timepoint [1] 333342 0
The time point will be 4 months after the intervention phase is completed (SMS has been sent to patients). This decision was made in May 2024, after recruitment but before the intervention period began.
Secondary outcome [1] 416681 0
This is a composite secondary outcome to measure adherence. We will calculate the number of patients who "opt out" of receiving future SMS (Interventions 1 & 2), the number of times the web link in the SMS is 'clicked on' and opened, and the number of times each of the videos are 'clicked on' to view (Intervention 2 only) to determine the level of adherence and compliance with the intervention. The data will be provided by Healthily using their website analytics.
Timepoint [1] 416681 0
The time point will be 4 months after the intervention phase is completed (SMS has been sent to patients). This decision was made in May 2024, after recruitment but before the intervention period began.
Secondary outcome [2] 416682 0
Economic evaluation: We will use a calibrated and validated microsimulation platform designed to evaluate cost, benefits and harms of colorectal cancer screening. We will estimate the cost effectiveness of each SMS intervention and the long term bowel cancer incidence and mortality outcomes among patients in the trial. We will also estimate budget impacts on the health care costs and long term bowel cancer incidence and mortality reduction in the Australian population if the interventions was adopted and implemented nationwide.
Timepoint [2] 416682 0
The time point will be 4 months after the intervention phase is completed (SMS has been sent to patients). This decision was made in May 2024, after recruitment but before the intervention period began.

Eligibility
Key inclusion criteria
General practice eligibility criteria:
• Practices have to be located either in Queensland or Victoria - we will randomise by remoteness using the Modified Monash Model to ensure all trial arms are equivalent (Metropolitan areas, regional centres, large, medium and small rural towns, and remote communities).
• Practices use electronic medical records (EMR) software compatible with and can host the NCSR (Best Practice, Medical Director 3/4).
• Have at least 2 full-time equivalent (FTE) GPs working in their general practice.
• Have a practice manager (or delegate) who is happy to champion the trial in the general practice throughout the time of the trial.
• Practices are willing to download the National Cancer Screening Register application onto their computer system.
• Practices agree for the researchers to train clinic staff to generate lists of eligible patients and populate these lists with the date the NBCSP kit is due in batches through a secure and encrypted process directly from the NCSR.
• All GPs agree to their eligible patients receiving the 'SMS only' or the 'SMS bundle' (randomisation happens after consent).
• Practices agree for the researchers to train practice staff to upload (once) the patient lists to the GoShare secure platform for automated SMS sending.
Patient inclusion criteria:
• Attend a participating general practice
• Aged between 49 and 60 years old who have been in touch with the practice three or more times in the previous two years.
• Due to receive a NBCSP kit during the time the intervention is being conducted
• Have not had a bowel cancer diagnosis
• Have not opted out of receiving and SMS
Minimum age
49 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria:
People will be eligible if:
- they are aged between 49 and 60 years old during the trial period,
- they are a regular patient at a general practice recruited into the trial (defined by their patient file having been opened at least three times in the previous two years),
- they have a mobile phone number recorded in the practice,
- they have a Medicare number recorded in the practice,
- they have not opted out of receiving SMS from their practice,
- they do not have a diagnosis of CRC in their EHR.
2) Assessed at the National Cancer Screening Register.
People identified as eligible in the general practice records will be linked with NCSR records and remain eligible for the trial if:
- they have matching record in the NCSR database,
- they are due to receive their NBCSP kit within the trial period,
People will be excluded if:
- their record extracted from the general practice EHR does not match with the records in the NCSR database,
- they have a diagnosis of CRC recorded in their NCSR record,
- they have opted out from receiving the NBCSP kit, as recorded in their NCSR record,
- they have put their NBCSP kit on hold, as recorded in their NCSR record,
- they have died, as recorded in their NCSR record,
- they are not due for screening because they have had a recent colonoscopy, as recorded in their NCSR record, and/or
- they are not due for screening because they have had a recent FIT elsewhere, as recorded in their NCSR record.

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)
Randomisation is at the general practice (cluster) level. Randomisation will be done "off-site" at a central administration site by a statistician blinded to the identity of all general practices. All researchers except for the trial coordinators and the trial lead will be blinded to the randomisation status of the general practices until the final analysis has been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will use a computer-generated allocation sequence, stratified into two groups by geographical remoteness using the Modified Monash Model (MMM) classifications 1-3 and 4-6 (7 includes very remote locations and will not be included) will be grouped together (1-3: metropolitan cities/regional, 4-6: rural/remote) with random permuted block sizes within each stratum. This will be done by the statistician who will be blinded to the identity of all the general practices.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
SMARTERscreen will require participation of 60 general practices with an average of 260 eligible patients to receive a NBCSP kit during the intervention phase (6 months) and coefficient of variation 0.76 to allow for variation of patient numbers across general practices. This will be sufficient to detect the minimally clinically meaningful difference of 10% absolute increase in participation in the NBCSP between each of the intervention arms and the control arm (44% vs 34%) and to detect a smaller difference of 7.5% between the two interventions arms. A national 10% increase in screening participation would prevent 24,300 bowel cancers, 16,800 deaths and save the health budget $300 million over current screening levels.

Logistical regression using general estimating equations with standard errors to allow for clustering by general practice will be used to test the difference between each intervention arm and the control arm. Estimates of the effect of the interventions will be reported as an odds ratio with 95% confidence interval and p value.

We will calculate the number of times the weblink in the SMS bundle is clicked on and the number of times each video is viewed. We will also calculate the number of times the patient opts-out of receiving future (SMS- only and SMS bundle)

We will provide estimates on budget impact on the health care cost and long term term bowel cancer incidence and mortality reduction in the Australian population if the intervention was adopted and implemented nation-wide. We will do this by using a calibrated and validated microsimulation platform designed to evaluated cost, benefits and harms of colorectal cancer screening.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2023
Actual
14/02/2023
Date of last participant enrolment
Anticipated
1/07/2023
Actual
25/07/2023
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
63
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
QLD,VIC

Funding & Sponsors
Funding source category [1] 312838 0
Government body
Name [1] 312838 0
National Health and Medical Research Council
Country [1] 312838 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
University of Melbourne
Centre for Cancer Research
Melbourne School of Population and Global Health
207 Bouverie St,
University of Melbourne.
Victoria 3010 Australia
Country
Australia
Secondary sponsor category [1] 314480 0
University
Name [1] 314480 0
University of Sydney
Address [1] 314480 0
University of Sydney
Daffodil Centre
153 Dowling st, Woolloomooloo NSW 2011
Country [1] 314480 0
Australia
Secondary sponsor category [2] 314490 0
Charities/Societies/Foundations
Name [2] 314490 0
Cancer Council Queensland
Address [2] 314490 0
553 Gregory Terrace
Fortitude Valley
QLD 4006
Country [2] 314490 0
Australia
Other collaborator category [1] 282500 0
Commercial sector/Industry
Name [1] 282500 0
Healthily Pty Ltd
Address [1] 282500 0
502, Level 5
492 St Kilda Road
Melbourne, Victoria 3004
Country [1] 282500 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312116 0
University of Melbourne: Human Research Ethics and Integrity,
Ethics committee address [1] 312116 0
Ethics committee country [1] 312116 0
Australia
Date submitted for ethics approval [1] 312116 0
16/11/2022
Approval date [1] 312116 0
09/01/2023
Ethics approval number [1] 312116 0
25313

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

Contacts
Principal investigator
Name 123534 0
Prof Mark Jenkins
Address 123534 0
University of Melbourne,
Centre for Epidemiology & Biostatistics
Melbourne School of Population and Global Health
207 Bouverie St
Carlton
Victoria 3010


Country 123534 0
Australia
Phone 123534 0
+61 407 756 012
Fax 123534 0
Email 123534 0
[email protected]
Contact person for public queries
Name 123535 0
Jennifer McIntosh
Address 123535 0
The University of Melbourne
Centre for Cancer Research
Melbourne School of Population and Global Health
207 Bouverie St,
Carlton
Victoria 3010 Australia
Country 123535 0
Australia
Phone 123535 0
+61 408 510 248
Fax 123535 0
Email 123535 0
[email protected]
Contact person for scientific queries
Name 123536 0
Jennifer McIntosh
Address 123536 0
The University of Melbourne
Centre for Cancer Research
Melbourne School of Population and Global Health
207 Bouverie St,
Carlton
Victoria 3010 Australia
Country 123536 0
Australia
Phone 123536 0
+61 408 510 248
Fax 123536 0
Email 123536 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
We will collect:
The number of eligible patients in each participating general practice by age (years) and sex (male / female)
The number of NBCSP FOBT results recorded by the NCSR by age and sex
The length of time between receiving a NBCSP kit and returning the kit
The number of patients eligible to be sent a SMS by age and sex (SMS only and SMS bundle)
The number of times the web links within the SMS is opened by age and sex of patients(SMS bundle only)
The number of times the videos are viewed by age and sex (SMS Bundle only)
The number of patients who opted out of receiving future SMS


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17841Informed consent form    385119-(Uploaded-04-07-2024-14-56-58)-SMARTERscreen_General practice consent form V1.2.pdf
17843Study protocolMcIntosh JG, Emery JD, Wood A, Chondros P, Goodwin BC, Trevena J, Wilson C, Chang S, Hocking J, Campbell T, Macrae F. SMARTERscreen protocol: a three-arm cluster randomised controlled trial of patient SMS messaging in general practice to increase participation in the Australian National Bowel Cancer Screening Program. Trials. 2023 Nov 13;24(1):723.https://doi.org/10.1186/s13063-023-07756-5  File attached 385119-(Uploaded-04-07-2024-14-56-58)-SMARTERscreen_McIntosh_2023.pdf
17877Other    SMARTERscreen General Practitioner Information she... [More Details] 385119-(Uploaded-20-02-2023-13-21-11)-Study-related document.pdf
18045Ethical approval    385119-(Uploaded-13-01-2023-11-29-43)-Study-related document.pdf
20696Study protocol    385119-(Uploaded-14-08-2023-12-54-33)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSMARTERscreen protocol: a three-arm cluster randomised controlled trial of patient SMS messaging in general practice to increase participation in the Australian National Bowel Cancer Screening Program.2023https://dx.doi.org/10.1186/s13063-023-07756-5
N.B. These documents automatically identified may not have been verified by the study sponsor.