Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000045415
Ethics application status
Approved
Date submitted
20/11/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Ready to Screen Trial - A trial of lung cancer screening recruitment strategies
Scientific title
The Ready to Screen Trial - A randomised-controlled cluster implementation trial of lung cancer screening recruitment strategies in primary care
Secondary ID [1] 313017 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer Screening 335214 0
Condition category
Condition code
Public Health 331766 331766 0 0
Health service research
Cancer 332635 332635 0 0
Lung - Small cell
Cancer 332637 332637 0 0
Lung - Mesothelioma
Cancer 332636 332636 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The National Lung Cancer Screening Program (NLCSP) will commence in Australia from July 2025. Program participants are expected to be referred by their general practitioner (GP) to take part in this targeted screening program and it is crucial to evaluate optimal recruitment strategies for those individuals who will be eligible.
The Ready To Screen trial seeks to explore whether participant intention to participate in the NLCSP is influenced by the provision of a different implementation strategy incorporating personalised invitations sent by a GP, receiving lung cancer screening information and offering a variety of participation pathways into program.

The Ready to Screen trial aims to test a bundled implementation strategy (against a simple implementation strategy) delivered via primary care practices to increase patient intention to screen for lung cancer in the upcoming NLCSP.

General practices assigned to the intervention arm will receive the Bundled Implementation Strategy including the core components (see Control condition) and five additional components:

1) Core component (as in control arm) – Initial letter mailout via standard mail or email including a co-designed brochure and invitation to participate in the R2S trial, AND
2) URL link to a “Ready To Screen” multilingual website where patients can learn more about lung cancer screening and calculate their eligibility for screening using an embedded smoking history calculator; AND
3) First reminder sent via Short Message Service (SMS) sent 2 weeks following the initial letter, directly to their mobile phone; AND
3) Second reminder sent via letter/email, sent 4 weeks following the initial invitation letter; AND
5) Co-designed posters displayed within their practice setting that will include a QR code and URL link to a Ready To Screen website. This includes posters in multiple community languages with links to the R2S website that contains translated materials; AND
6) Future Health Today (FHT) clinical decision support system features turned on prompting GPs to consider discussing NLCSP/update patient smoking history for patients flagged in the system as potentially eligible (Practice opt-in component).

The trial period will last six months. The intervention period will span three months, during which GP practices will implement the strategy in their practice and then data will be collected over additional three months.

Adherence to the intervention will be monitored by service use data recorded by the research nurse (type, frequency, and duration of intervention components/invitations disseminated/utilised by practices) and participant self-reported data (proportions of service users receiving/responding to the invitations).

Practice administrator/delegate will receive a once-off training provided by FHT developers (Department of General Practice, The University of Melbourne) in the use of FHT platform. The training will upskill general practice administrators to prepare lists of patients potentially eligible for screening and contact eligible patients informing them about the upcoming NLCSP (see intervention component #6 above).

The practice administrators will use FHT (or any other compatible patient record management tool) to generate a list/report to identify potentially eligible participants. The eligible patient list will be reviewed for exclusions. The initial invitation letters and the subsequent reminders will be sent by the practice administrator, with support provided by the research nurse.

Prior to delivery of the intervention, all GPs in the practices enrolled in the intervention group will receive a 1-hour telehealth educational (CPD-accredited) training delivered by the research team. The CPD training will:
• Upskill GPs in their knowledge of lung cancer, screening, referral and diagnosis;
• Train GPs to navigate the NLCSP recommendations, identify eligible patients, provide advice and refer to screening; and
• Train GPs is how to update/record their patients’ smoking history and calculate smoking-history duration (i.e., pack years).



Intervention code [1] 329563 0
Early detection / Screening
Comparator / control treatment
General practices assigned to the control arm will receive the Core Implementation Strategy consisting of the following components:

1) Initial letter mailout via standard mail or email, to inform eligible patients about the ReadyToScreen trial and the forthcoming NLCSP, and
2) Co-designed information brochure about ReadyToScreen trial.
Control group
Active

Outcomes
Primary outcome [1] 339421 0
Effectiveness of the implementation strategy assessed as Intention to screen, and defined as proportion of participants who, following the LCS invitation, have registered to indicate an intention to screen in the upcoming National Lung Cancer Screening Program
Timepoint [1] 339421 0
At post-intervention - The primary endpoint will be collected approximately two to six weeks from point of first contact (i.e., invitation letter mailing date).
Secondary outcome [1] 439900 0
Implementation Delivery/Fidelity (Composite): Description of implementation strategy components delivered by practices and received by patients.
Timepoint [1] 439900 0
At post-intervention- The secondary endpoint will be collected approximately two to six weeks from point of first contact (invitation letter mailing date).
Secondary outcome [2] 439891 0
Attrition (Composite) = Proportions and differential rates of uptake by patient characteristics and implementation strategy
Timepoint [2] 439891 0
At post-intervention - The secondary endpoint will be collected approximately two to six weeks from point of first contact (invitation letter mailing date).
Secondary outcome [3] 439919 0
Implementation mechanism: Impact of patient-related trust in processionals
Timepoint [3] 439919 0
At post-intervention - The secondary endpoint will be collected approximately 2-6 weeks post baseline.
Secondary outcome [4] 439913 0
Reach of the intervention will be assesses by examining: Uptake
Timepoint [4] 439913 0
At follow-up - The secondary endpoint will be collected at the end of the patient data collection - approximately 3-6 months following the baseline
Secondary outcome [5] 439921 0
Implementation process: Impact of service-related Readiness for change
Timepoint [5] 439921 0
At follow-up - The secondary endpoint will be collected at the end of the patient data collection - approximately 3-6 months following the baseline
Secondary outcome [6] 439914 0
Reach of the intervention will be assesses by examining: Representativeness
Timepoint [6] 439914 0
At follow-up - The secondary endpoint will be collected at the end of the patient data collection - approximately 3-6 months following the baseline
Secondary outcome [7] 442568 0
Adoption of the intervention will be assessed as: Engagement (Staff)
Timepoint [7] 442568 0
At follow-up - The secondary endpoint will be collected approximately 6-9 months following the trial completion
Secondary outcome [8] 439918 0
Implementation mechanism: Impact of patient-related psychological domains
Timepoint [8] 439918 0
At post-intervention - The secondary endpoint will be collected approximately 2-6 weeks post baseline.
Secondary outcome [9] 439917 0
Implementation mechanism: Impact of patient related attitudes to screening (composite)
Timepoint [9] 439917 0
At post-intervention - The secondary endpoint will be collected approximately 2-6 weeks post baseline.
Secondary outcome [10] 439912 0
Reach of the intervention will be assesses by examining: Participation
Timepoint [10] 439912 0
At post-intervention - The secondary endpoint will be collected approximately two to six weeks from point of first contact (invitation letter mailing date).
Secondary outcome [11] 439930 0
Maintenance of the intervention (cluster level): Perceived sustainability:
Timepoint [11] 439930 0
At follow-up - The secondary endpoint will be collected at the end of the patient data collection - approximately 3-6 months following the baseline
Secondary outcome [12] 439926 0
Implementation process: Inner Settings (e.g., climate, culture, stress, leadership)
Timepoint [12] 439926 0
At follow-up - The secondary endpoint will be collected at the end of the patient data collection - approximately 3-6 months following the baseline
Secondary outcome [13] 442572 0
Adoption Barriers and enablers
Timepoint [13] 442572 0
At follow up
Secondary outcome [14] 442573 0
Reach: Barriers and enablers
Timepoint [14] 442573 0
At Follow-up
Secondary outcome [15] 442569 0
Adoption of the intervention will be assessed as: Intent to refer
Timepoint [15] 442569 0
At follow-up - The secondary endpoint will be collected approximately 6-9 months following the trial completion
Secondary outcome [16] 439915 0
Implementation Outcome: Costs of the Implementation strategy
Timepoint [16] 439915 0
throughout the trial delivery period.
Secondary outcome [17] 439929 0
Maintenance of the intervention (cluster level): Screening adherence
Timepoint [17] 439929 0
At follow-up - The secondary endpoint will be collected approximately 6-9 months following the trial completion
Secondary outcome [18] 442567 0
Adoption of the intervention will be assessed as: Engagement (Practices)
Timepoint [18] 442567 0
At follow-up - The secondary endpoint will be collected approximately 6-9 months following the trial completion

Eligibility
Key inclusion criteria
Clusters/Practices
28 general practice clinics located around Australia will be randomly allocated to the intervention or the control group
Inclusion criteria
• Practice is located anywhere in Australia
• Practice utilises electronic medical record (EMR) software (e.g., Best Practice, Medical Director) to record patient details
• Practice has an existing capability to send SMS reminders to patients
• At least 1 practice manager/administrator and minimum of two general practitioners (GP) employed at the practice


Patients will be approached via their GP practice
Inclusion criteria
• Age between 50 and 70 years as at July 1st, 2025
• Current or previous history of smoking (quit less that 10 years ago or quit date unknown)
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients Exclusion criteria
• Current or prior history of lung cancer
• Patient preferred communication language is not English or one of the following community languages (Arabic, Cantonese, Italian, Mandarin, Macedonian, Punjabi, Vietnamese)
• Indication of request for no SMS in patient file

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)
The independent statistician randomising the general practices will be blinded to the identity of the participating general practices by using unique codes for each practice and will not be involved in the trial recruitment and data collection. Uninformative codes A and B will be used for the trial arm allocation. Prior to random allocation, the research team will randomly assign the uninformative codes to each of the trial arms and keep it securely stored and not disclose the key to the statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur at the beginning of the trial. Practices will be randomly allocated in 1:1 ratio to the intervention or control arms. An independent statistician will produce a computer-generated randomisation scheme using block randomisation with block sizes of 4 to 6 to maintain balance between treatment arms
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2025
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
31/05/2026
Actual
Sample size
Target
12096
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 317458 0
Government body
Name [1] 317458 0
NHMRC-MRFF
Country [1] 317458 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319746 0
None
Name [1] 319746 0
Address [1] 319746 0
Country [1] 319746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316173 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 316173 0
Ethics committee country [1] 316173 0
Australia
Date submitted for ethics approval [1] 316173 0
Approval date [1] 316173 0
20/11/2024
Ethics approval number [1] 316173 0

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

Contacts
Principal investigator
Name 137026 0
A/Prof Nicole Rankin
Address 137026 0
Melbourne School of Population and Global Health | Faculty of Medicine, Dentistry and Health Sciences Level 4, 207 Bouverie Street The University of Melbourne, Victoria 3010 Australia
Country 137026 0
Australia
Phone 137026 0
+61 459867617
Fax 137026 0
Email 137026 0
[email protected]
Contact person for public queries
Name 137027 0
Dr Dzenana Kartal
Address 137027 0
Melbourne School of Population and Global Health | Faculty of Medicine, Dentistry and Health Sciences Level 4, 207 Bouverie Street The University of Melbourne, Victoria 3010 Australia
Country 137027 0
Australia
Phone 137027 0
+61 459867617
Fax 137027 0
Email 137027 0
[email protected]
Contact person for scientific queries
Name 137028 0
Dr Dzenana Kartal
Address 137028 0
Melbourne School of Population and Global Health | Faculty of Medicine, Dentistry and Health Sciences Level 4, 207 Bouverie Street The University of Melbourne, Victoria 3010 Australia
Country 137028 0
Australia
Phone 137028 0
+61 459867617
Fax 137028 0
Email 137028 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.