Increasing informed participation in lung cancer screening using pathway navigation . A multi-centre randomised controlled trial using a type one hybrid effectiveness-implementation design
Lung cancer screening
This is a multi-centre randomised controlled trial study with decentralised/remote follow-up, assessing the impact of a pathway navigator on participation in lung cancer screening (within the Lung Cancer Screening (LCS) programme). A navigator is a trained healthcare professional who can support people to overcome barriers to attendance via motivational interviewing and practical support. The primary outcome will be attendance at their next LCS appointment, obtained from LCS records. Secondary outcomes include attendance at subsequent LCS appointments over the 24-month screening cycle (from LCS records), whether lung cancer was diagnosed, whether it was screen-detected or non-screen detected and what stage the tumour was (obtained via data linkage with the National Cancer Registration and Analysis Service; NCRAS). A cost-consequence analysis will be undertaken, considering all relevant and accessible costs and outcomes. We will include LCS delivery costs, collected via study records, and if accessible, the Hospital Episode of Statistics (HES) to determine secondary care costs, costed using the National Schedule of NHS Costs. An implementation analysis will be undertaken, including qualitative interviews assessing the acceptability of navigator involvement to LCS participants and staff. People will be eligible for the study if they miss an invited CT scan appointment (baseline or follow-up) within the LCS. Individuals who have declined consent to their clinical data being used for research (recorded at initial LCS appointment and recorded on participants’ electronic LCS record) or have selected the National Data Opt-out on their NHS record will not be eligible. Eligible people will be identified from the LCS clinic lists. Anyone who has not attended a scheduled LCS appointment (baseline or follow-up) will be randomised 50:50 to either usual care or to be contacted by the navigator. Usual care will follow the standard LCS provider’s approach to missed appointments
To be eligible for IMPALA, participants must: 1. Be eligible to participate in NHS England’s LCS programme, AND 2. Have been invited to an initial face-to-face appointment or follow-up CT scan, AND 3. Did Not Attend (DNA) their scheduled LCS appointment, AND 4. Have opted-in for their clinical data to be used for research at their initial LCS telephone triage appointment.
Participants are not eligible for the trial if any of the following apply: 1. Participant declines to consent to share their data for research purposes at triage or face-to-face assessment 2. Participants have selected the National Data Opt-Out on their NHS record 3. Participant have returned their opt-out form after initial contact or randomisation 4. Participant has declined to participate in LCS with a status recording of “opt-out” on their LCS record or GP record 5. Participant’s non-attendance at LCS is due to no longer being eligible e.g. moving out of the area, ageing out, or change in clinical circumstances. 6. Participant has been randomised to IMPALA following non-attendance at a previous LCS appointment.