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Trial registered on ANZCTR


Registration number
ACTRN12621001309875
Ethics application status
Approved
Date submitted
30/06/2021
Date registered
27/09/2021
Date last updated
8/09/2024
Date data sharing statement initially provided
27/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising lung cancer screening for Maori: A study of comparative invitation processes
Scientific title
A study to assess the effectiveness of a primary care vs central hub invitation to lung cancer screening for Maori participants aged 55-74 in Auckland and Waitemata District Health Boards
Secondary ID [1] 304665 0
None
Universal Trial Number (UTN)
U1111-1267-3946
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer screening 322623 0
Condition category
Condition code
Public Health 320244 320244 0 0
Other public health
Cancer 321031 321031 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is focused on Maori participants who are at high risk of lung cancer. Groups will be cluster randomized (at general practice level) 1:1 between central hub and primary care hub invitation approaches, and the aim is to scan 550 participants in total.

Lung cancer is a common cancer and cause of death for both Maori and non-Maori in New Zealand, but is especially prevalent in Maori. Earlier detection of asymptomatic lung cancer through lung cancer screening using low-dose CT scans has been proven to shift the stage of diagnosis of lung cancer, and to reduce mortality. There is currently no national programme for lung cancer screening in New Zealand, and before any progamme can be introduced there are key implementation questions that need to be addressed. In addition, any programme must ensure that Maori participation is at least equal to non-Maori participation to ensure that the already significant equity gap is not increased by such a programme. In this community cluster Randomised Controlled Trial, two lung cancer screening invitation pathways will be tested end to end, including invitation methods, risk assessment, shared decision making and CT scan.
The key intervention being tested between the two groups is whether recruitment rates are better with a GP led invitation process. Participants in the GP led (intervention) arm of the study will be invited to participate via their GP practice.
The invitation will be sent initially via a letter and information booklet, with follow up phone calls / emails to ascertain willingness to participate.
Key study processes are listed below. The risk assessment and shared decision making will be facilitated by the primary care nurse, either face to face or over the phone;

Risk assessment, conducted in a face to face visit or phone call and expected to take around 20 minutes. Only those participants identified as at high risk of developing cancer will be invited for a CT scan.

Shared decision making, conducted in a face to face visit or phone call and expected to take around 30 minutes. This can be done immediately after the risk assessment, or at a separate appointment. In the shared decision making process, all participants identified as being at high enough risk to undergo CT scan will be taken through the potential risks and benefits of having a CT scan for lung cancer screening.

CT scan. If a participant consents, a separate appointment will be made for a CT scan at a community radiology facility. The scan appointment will take around 30 minutes and will be conducted by a qualified radiologist.

Follow up will be personalised according to the results of the CT scan, where any findings, including incidental findings, will be followed up accordingly.

Intervention code [1] 321025 0
Early detection / Screening
Comparator / control treatment
The control arm of the study will be participants invited via a centralised process.

Participants will be invited to participate via an initial letter and information booklet, sent from the study central hub. This invitation will be followed up by a phone call to ascertain willingness to participate.


Key study processes are listed below. The risk assessment and shared decision making will be facilitated by the study nurse within the central hub, either face to face or over the phone;

Risk assessment, conducted in a face to face visit or phone call and expected to take around 20 minutes. Only those participants identified as at high risk of developing cancer will be invited for a CT scan.

Shared decision making, conducted in a face to face visit or phone call and expected to take around 30 minutes. This can be done immediately after the risk assessment, or at a separate appointment. In the shared decision making process, all participants identified as being at high enough risk to undergo CT scan will be taken through the potential risks and benefits of having a CT scan for lung cancer screening.

CT scan. If a participant consents, a separate appointment will be made for a CT scan at a community radiology facility. The scan appointment will take around 30 minutes and will be conducted by a qualified radiologist.

Follow up will be personalised according to the results of the CT scan, where any findings, including incidental findings, will be followed up accordingly.


The two groups will be cluster randomized (at general practice level) 1:1 between central hub and primary care hub invitation methods.
Control group
Active

Outcomes
Primary outcome [1] 328105 0
LCS screening uptake among those eligible; difference between the primary care and central hub groups in the proportion of Maori eligible for LCS CT scan who attended and underwent the scan.
Data will be collected using an "advanced form" in the Primary Care management system, along with study records in the central hub that will record all invitations sent, responses received, risk assessments conducted (& results of these), shared decision making discussions undergone (& outcomes of these) and scans booked and attended.
Timepoint [1] 328105 0
At the conclusion of the 3 year study
Secondary outcome [1] 397642 0
Scan positivity - number of positive scans per group, stratified by gender, smoking exposure and other demograhic factors.
Scan positivity will be assessed from scan reports, which will be sent directly to the study radiologist from the community scanning provider. The study radiologist will generate a report that goes to participants medical records and to the study co-ordinator.
Timepoint [1] 397642 0
3 years (interim analysis will be conducted at 1 and 2 years also)
Secondary outcome [2] 397643 0
Cancer detection rates, including the number and proportion of cancers detected by stage and grade, and proportion of cancers detected that are surgically operable (composite outcome - all of these outcomes are subsets of the cancer detection rate). This will be assessed from patient medical records.
Timepoint [2] 397643 0
3 years (interim analysis will be conducted at 1 and 2 years also)
Secondary outcome [3] 398338 0
Types and rates of incidental findings (composite outcome)

Potential incidental findings include interstitial lung disease, emphysema, airways disease (COPD, bronchiectasis), metastases from other primary cancers, cardiac abnormalities etc.

These will be identified from the CT scan, and assessed from medical records.
Timepoint [3] 398338 0
3 years (interim analysis will be conducted at 1 and 2 years also)

Eligibility
Key inclusion criteria
Participants will be recorded or self-identified as Maori in their primary care enrolment register,
Aged between 55 to 74,
Enrolled in participating general practices in Auckland or Waitemata District Health Boards
Are able to provide informed consent and able to agree to participate.
Minimum age
55 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Never smokers,
Those with clinical symptoms suspicious for lung cancer,
Those with a previous diagnosis of lung cancer,
People who have received chemotherapy or cytotoxic drugs within the last six months,
Pregnancy.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation by primary care practice
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Our sample size estimate anticipates that 4412 participants will be invited to undergo risk assessment, with 3309 participants being expected to complete this assessment. Of these, we expect that 1134 participants will be eligible for low dose CT scanning, and that 500-550 participants will consent to undergo LDCT scan for lung cancer screening. After the first 50 participants have been scanned, we will pause the study assess the pathway and methods, to ensure they are optimal before expanding the study to the next 500 scans which will test the invitation methods. Should the proportions of participants agreeing to risk assessment and / or scan differ from our predictions, these numbers will be adjusted accordingly to allow us to reach the 500-550 scan target.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/10/2021
Actual
18/01/2022
Date of last participant enrolment
Anticipated
2/02/2024
Actual
12/03/2024
Date of last data collection
Anticipated
1/07/2024
Actual
28/06/2024
Sample size
Target
550
Accrual to date
Final
504
Recruitment outside Australia
Country [1] 23933 0
New Zealand
State/province [1] 23933 0
Auckland

Funding & Sponsors
Funding source category [1] 309031 0
Government body
Name [1] 309031 0
Health Research Council
Country [1] 309031 0
New Zealand
Primary sponsor type
Government body
Name
Waitemata District Health Board
Address
15 Shea Terrace
Takapuna
Auckland
0622
Country
New Zealand
Secondary sponsor category [1] 309968 0
None
Name [1] 309968 0
Address [1] 309968 0
Country [1] 309968 0
Other collaborator category [1] 281897 0
University
Name [1] 281897 0
Univeristy of Otago
Address [1] 281897 0
18 Frederick Street
North Dunedin
9016
Country [1] 281897 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308911 0
Health and Disability Ethics Committee (Central)
Ethics committee address [1] 308911 0
Ethics committee country [1] 308911 0
New Zealand
Date submitted for ethics approval [1] 308911 0
30/06/2021
Approval date [1] 308911 0
04/10/2021
Ethics approval number [1] 308911 0
21/CEN/174

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

Contacts
Principal investigator
Name 112314 0
Prof Sue Crengle
Address 112314 0
18 Frederik St
University of Otago
North Dunedin
Dunedin
9016
Country 112314 0
New Zealand
Phone 112314 0
+64 21 832 346
Fax 112314 0
Email 112314 0
sue.crengle@otago.ac.nz
Contact person for public queries
Name 112315 0
Kate Parker
Address 112315 0
Waitemata District Health Board
15 Shea Terrace
Takapuna
6022
Country 112315 0
New Zealand
Phone 112315 0
+64 21 678 907
Fax 112315 0
Email 112315 0
kate.parker2@waitematadhb.govt.nz
Contact person for scientific queries
Name 112316 0
Sue Crengle
Address 112316 0
18 Frederik St
University of Otago
North Dunedin
Dunedin
9016
Country 112316 0
New Zealand
Phone 112316 0
+64 21 832 346
Fax 112316 0
Email 112316 0
sue.crengle@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to Maori data sovereignty principles, no individual data will be made available to researchers outside of this study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12361Study protocol  kate.parker2@waitematadhb.govt.nz Final protocol is available on request
12363Informed consent form  kate.parker2@waitematadhb.govt.nz Final ICF is available on request
12364Ethical approval  kate.parker2@waitematadhb.govt.nz Ethics approval documentation available on request



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.