Authors
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Waitemata District Health Board -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: 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, conduct CONDITION: Cancer ‐ Lung ‐ Non small cell Lung cancer screening; ; Lung cancer screening Public Health ‐ Other public health PRIMARY OUTCOME: 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. [At the conclusion of the 3 year study] SECONDARY OUTCOME: 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. ; [3 years (interim analysis will be conducted at 1 and 2 years also)] 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. ; [3 years (interim analysis will be conducted at 1 and 2 years also)] 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. [3 years (interim analysis will be conducted at 1 and 2 years also)] 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.
Epistemonikos ID: 05b3483b81f839683ce4b9ead8bb2235c3ec6afc
First added on: Aug 25, 2024