Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001212640
Ethics application status
Approved
Date submitted
19/09/2023
Date registered
24/11/2023
Date last updated
24/11/2023
Date data sharing statement initially provided
24/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Max Up - Comparing uptake of lung cancer screening and smoking cessation outcomes in Quitline clients receiving 3 months vs 12 months of smoking cessation Nicotine Replacement Therapy and counselling.
Scientific title
Max Up – A randomised controlled trial of biochemically verified smoking cessation abstinence testing 3 months vs 12 months of NRT and counselling in Quitline clients eligible for lung cancer screening who complete a low dose chest CT scan.
Secondary ID [1] 309914 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nicotine dependence 330380 0
lung cancer 330381 0
Condition category
Condition code
Public Health 327221 327221 0 0
Health promotion/education
Cancer 327222 327222 0 0
Lung - Small cell
Mental Health 328628 328628 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a scheduled four 1:1 Quitline counselling sessions via telephone, with extra calls as requested by the client, for 12 weeks post the initial contact with Quitline. Call duration ranges from 10 to 30 minutes sessions, dependent on client need. Follow up SMS invites to engage with the Quitline service will be scheduled at 10-week intervals up to 40 weeks post initial contact. Participants will be able to engage with the Quitline service as much as they wish to over the 12 months period of the study.
Participants will be provided with combined nicotine replacement therapy (NRT) for up to 12 weeks. Following the initial 12 weeks, participants will be eligible for further NRT at their request, for a further 40 weeks post initial intervention. NRT products comprise 21mg NRT patch, 4mg NRT gum, 4mg NRT lozenge and NRT Quick mist spray and are supplied alone or in combination based on the individual requirements of each client following discussion with a counsellor. NRT will distribute to the participant via Australia Post. Use of and response to NRT including adverse reactions will be captured by Quitline counsellors in the counselling sessions. Participants will also provide information on the NRT used in the research questionnaires.
As this is a pragmatic study, the Low dose CT scan of the chest will be scheduled by the Radiology provider and the participants at a time of the participants choosing. The request form for the CT scan will be provided to the Radiology provider once enrolled. The CT scan must be undertaken within 12 months of enrolment.
Intervention code [1] 326343 0
Treatment: Drugs
Intervention code [2] 326344 0
Early detection / Screening
Comparator / control treatment
Participants will receive a scheduled four 1:1 Quitline counselling sessions via telephone, with extra calls as requested by the client, for 12 weeks post the initial contact with Quitline. Call duration ranges from 10 to 30 minutes sessions, dependent on client need. Participants will be able to engage with Quitline as much as they wish to over 12 months from enrolment in the study.
Participants will be provided with combined nicotine replacement therapy (NRT) for up to 12 weeks. NRT products comprise 21mg NRT patch, 4mg NRT gum, 4mg NRT lozenge and NRT Quick mist spray and are supplied alone or in combination based on the individual requirements of each client following discussion with a counsellor. NRT will be distributed to the participant via Australia Post. Use of and response to NRT including adverse reactions will be captured by Quitline counsellors in the counselling sessions. Participants will also provide information on the NRT used in the research questionnaires.
As this is a pragmatic study, the Low dose CT scan of the chest will be scheduled by the Radiology provider and the participants at a time of the participants choosing. The request form for the CT scan will be provided to the Radiology provider once enrolled in the study. The CT scan must be undertaken within 12 months of enrolment.
Control group
Active

Outcomes
Primary outcome [1] 335106 0
1. The ratio of completed baseline CT scans in participants enrolled in the study. This will assess the feasibility of using Qutline as a recruitment pathway into lung cancer screening
2. Completed CT scan synoptic reports will be provided by the Radiology providers to the study team
Timepoint [1] 335106 0
assessed at 12 months post randomisation.
Primary outcome [2] 335107 0
Sustained bio verified smoking abstinence of 6 months, assessed at 12 months post enrolment using either salivary cotinine tests, exhaled Carbon Monoxide (CO) or urine cotinine tests.
Timepoint [2] 335107 0
assessed at 12 months post randomisation
Secondary outcome [1] 423005 0
Self-reported 7-day point prevalence smoking cessation
Timepoint [1] 423005 0
Commencing 3 months post randomisation, with follow up every 3 months for the first year, then once a year for 4 years.
Secondary outcome [2] 423009 0
Cigarettes smoked per day at 3 months, determined by participant self-report via study specific health questionnaire.
Timepoint [2] 423009 0
Commencing 3 months post randomisation, with follow up every 3 months for the first year, then once a year for 4 years.
Secondary outcome [3] 423013 0
Number of quit attempts lasting more than 24 hours, determined by participant self-report via study specific health questionnaire.
Timepoint [3] 423013 0
12 months post randomisation
Secondary outcome [4] 423014 0
Proportion of invitees completing a lung cancer screening (LCS) eligibility check who have Prostate, Lung, Colorectal, and Ovarian model (PLCOm2012) lung cancer risk above screening threshold of >=1.51% or who meet Medical Services Advisory Committee (MSAC) criteria or United States Preventative Services Task Force (USPTF) criteria. This data will be collected by study-specific eligibility questionnaire.
Timepoint [4] 423014 0
12 months post recruitment invite
Secondary outcome [5] 423015 0
Lung cancer detection rate (screen-detected and interval cancers: excluded non-invasive disease), Determined by participant self-report via study specific health questionnaires, and subsequent review of medical records if required.
Timepoint [5] 423015 0
12 months post randomisation
Secondary outcome [6] 423016 0
Proportion of early stage/late-stage lung cancer. Data collected from CT scan synoptic reports provided by Radiologists. Follow up data determined by participant self-report via study specific questionnaires, and subsequent review of medical records if required.
Timepoint [6] 423016 0
12 months post randomisation
Secondary outcome [7] 423017 0
Proportion of participants with early-stage disease undergoing surgery. Follow up data determined by participant self-report via study specific questionnaires, and subsequent review of medical records if required.
Timepoint [7] 423017 0
12 months post randomisation
Secondary outcome [8] 423018 0
Frequency of invasive procedures (image guided or surgical biopsies/resection) for benign disease. Follow up data determined by participant self-report via study specific questionnaires, and subsequent review of medical records if required.
Timepoint [8] 423018 0
12 months post randomisation
Secondary outcome [9] 423019 0
Quitline clients consenting to invite/Quitline clients eligible for invite. Data collected by Quitline within the Client Resource Manager (CRM) database.
Timepoint [9] 423019 0
12 months post recruitment invite
Secondary outcome [10] 423020 0
smoking cessation intervention engagement. Data collected by Quitline within the Client Resource Manager (CRM) database and participant self-report via study specific health questionnaires.
Timepoint [10] 423020 0
12 months post randomisation
Secondary outcome [11] 423021 0
Participant feedback on use of, and satisfaction with the counselling and Nicotine Replacement therapy at each time point. This is a composite secondary outcome. Data collected from participant self-report via study specific questionnaire
Timepoint [11] 423021 0
Commencing 3 months post randomisation, with follow up at 6, 9 and 12 months post randomisation.
Secondary outcome [12] 423022 0
Cost-effectiveness and budget impact analysis (composite secondary outcome). Costs of implementing the intervention will be monitored and analysed, including intervention staff effort, provider time, costs of telephone counselling, NRT/pharmacotherapy costs, captured through the Quitline and LCS databases, with linked Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) data to capture overall healthcare costs. Using a health services perspective, cost-effectiveness will be measured by the incremental cost per additional participant with biochemically verified abstinence at 12 months. The results of the trial will inform modelled estimates of the potential long-term health and cost benefits of these interventions at a national level and the impact on overall cost-effectiveness of a targeted Australian LCS program using the Daffodil Centre’s microsimulation model.
Timepoint [12] 423022 0
1 year prior to enrolment to 5 years post enrolment
Secondary outcome [13] 423023 0
Participant compliance with follow up CT recommendations. Data will be participant self-report via study specific health questionnaires. Participant medical records will be reviewed if required.
Timepoint [13] 423023 0
Commencing 3 months post randomisation, with follow up at 6, 9 and 12 months post randomisation if applicable.
Secondary outcome [14] 423024 0
Qualitative feedback on screening enablers and barriers and smoking cessation experience (composite secondary outcome)

Subsets of participants will be invited to participate in individual semi-structured interviews or focus groups. To facilitate this, all clients, including those who decline to check LCS eligibility or decline to enrol in the trial will be asked if they will allow the study team to contact them for possible future interviews or focus groups.
Timepoint [14] 423024 0
12 months post recruitment invite

Eligibility
Key inclusion criteria
1. Persons invited by Quitline who currently smoke,
2. Aged 50 – 80
3. Have a PLCOm2012 score of >=1.51%
4. 20 pack year smoking history
5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
6. Ability to provide own consent
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinical symptoms suspicious for lung cancer e.g. hemoptysis, chest pain, unexplained weight loss
2. Any medical condition, such as severe heart disease (e.g. unstable angina, chronic congestive heart failure), acute or chronic respiratory failure, home oxygen therapy, bleeding disorder, that in the opinion of the investigator could jeopardize the subject’s safety during participation in the study or unlikely to benefit from screening due to shortened life-expectancy from the co-morbidities
3. Have been previously diagnosed with lung cancer
4. Have had other non-curatively treated cancer outside the lung
5. Pregnancy
6. Pneumonia or bronchitis requiring antibiotic treatment within the last 12 weeks
7. Unwilling to have a spiral chest CT
8. Chest CT within 2 years
9. Does not fit into CT scanner table due to gross obesity
10. Cannot lie on CT scanning table on the back with arms over the head
11. Received chemotherapy or cytotoxic drugs within the last 6 months
12. Unwilling to sign a consent

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)
central randomisation allocated by a computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
permuted block randomisation
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2030
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24929 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 40581 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 314095 0
Government body
Name [1] 314095 0
National Health Medical Research Council
Country [1] 314095 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Qld, 4067
Country
Australia
Secondary sponsor category [1] 316011 0
None
Name [1] 316011 0
none
Address [1] 316011 0
n/a
Country [1] 316011 0
Other collaborator category [1] 282817 0
Charities/Societies/Foundations
Name [1] 282817 0
Cancer Council Australia
Address [1] 282817 0
GPO Box 4708 Sydney NSW 2001
Country [1] 282817 0
Australia
Other collaborator category [2] 282818 0
Charities/Societies/Foundations
Name [2] 282818 0
Lung Foundation
Address [2] 282818 0
PO Box 1949, Milton QLD 4064
Country [2] 282818 0
Australia
Other collaborator category [3] 282819 0
Government body
Name [3] 282819 0
Queensland Health - Prevention Division
Address [3] 282819 0
Level 1, 15 Butterfield St, Herston, Qld, 4006
Country [3] 282819 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313234 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 313234 0
Metro North Office of ResearchLevel 7, Block 7, RBWH CampusHerston Qld 4029
Ethics committee country [1] 313234 0
Australia
Date submitted for ethics approval [1] 313234 0
05/07/2023
Approval date [1] 313234 0
04/09/2023
Ethics approval number [1] 313234 0
92623

Summary
Brief summary
This purpose of this study is to assess the effectiveness of using Quitline as a referral pathway into lung cancer screening, and to assess whether combining Nicotine Replacement Therapy and Quitline telephone counselling interventions in current smokers is effective for people at risk of lung cancer.
Who is it for?
You may be eligible for this trial if you are aged between 50 – 80 years old, have a Prostate Lung Colorectal Ovarian model 2012 (PLCOm2012) score of >=1.51% and are a person who currently smokes with a 20-pack year smoking history. The PLCOm2012 model has been developed for lung cancer detection, and a score of >=1.51% means you are eligible for lung cancer screening.

Study details
Participants will be randomly allocated by chance (similar to flipping a coin) to the intervention group or the control group. Participants allocated to the intervention will be receive Nicotine Replacement Therapy and Quitline telephone counselling interventions for 12 months. While those participants who are randomised into the control group will Nicotine Replacement Therapy and Quitline telephone counselling interventions for 12 weeks (3 months). Participants who are eligible for lung cancer screening (based on certain criteria [PLCOm2012 > 1.5%, Have a > 20 pack year smoking history), will have a free CT scan of the lungs (within 12 months of enrolment in the study).
Questionnaires will be collected every three months for the first year to assess the acceptability of the intervention and then once a year for 4 years to assess patient reported outcomes.
It is hoped this intervention will help design a national Australian Lung Cancer Screening Program.
Trial website
Trial related presentations / publications
n/a
Public notes

Contacts
Principal investigator
Name 127434 0
A/Prof Henry Marshall
Address 127434 0
Level 2 Administration building,The Prince Charles Hospital,627 Rode Rd, Chermside, Qld, 4032
Country 127434 0
Australia
Phone 127434 0
+61 731396805
Fax 127434 0
Email 127434 0
henry.marshall@health.qld.gov.au
Contact person for public queries
Name 127435 0
Ms Jenny Peek
Address 127435 0
Level 2 Administration building,The Prince Charles Hospital,627 Rode Rd, Chermside, Qld, 4032
Country 127435 0
Australia
Phone 127435 0
+61 731396626
Fax 127435 0
Email 127435 0
jenny.peek@health.qld.gov.au
Contact person for scientific queries
Name 127436 0
A/Prof Henry Marshall
Address 127436 0
Level 2 Administration building,The Prince Charles Hospital,627 Rode Rd, Chermside, Qld, 4032
Country 127436 0
Australia
Phone 127436 0
+61 731396805
Fax 127436 0
Email 127436 0
henry.marshall@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Aggregate deidentified data will be shared with institutions with appropriate Human Ethical Research approval


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.