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Increasing informed participation in lung cancer screening using pathway navigation

Increasing informed participation in lung cancer screening using pathway navigation . A multi-centre randomised controlled trial using a type one hybrid effectiveness-implementation design

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN33418225
Enrollment
2400
Registered
2025-05-01
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer screening Cancer

Interventions

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 Can
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

Sponsors

North Bristol NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
55 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Attendance at the subsequent (i.e. recently defaulted and rescheduled) Lung Cancer Screening (LCS) appointment measured using patient LCS records. The outcome will be binary (yes/no) and will be collected within a month of the intervention.

Secondary

MeasureTime frame
1. Attendance at 24-month LCS appointment, reported as the proportion of eligible participants measured using patient LCS records. The outcome will be binary (yes/no) as collected on routine LCS databases. 2. Attendance at 3-month interval scan, reported as the proportion of eligible participants amongst those who have been invited for an interval 3-month scan measured using patient LCS records. The outcome will be binary (yes/no) as collected on routine LCS databases. 3. Attendance at 12-month interval scan, reported as the proportion of eligible participants amongst those who have been invited for an interval 12-month scan measured using patient LCS records. The outcome will be binary (yes/no) as collected on routine LCS databases. 4. Complete attendance at LCS invitations, reported as the number of participants attending all invited LCS appointments after randomisation for which they are eligible (i.e. before death/diagnosis/moving away) measured using patient LCS records. 5. Screen-detected lung cancer diagnoses (binary: yes/no), histological sub-type (categorical: small cell, adenocarcinoma, squamous cell, NSCLC NOS and other) and stage (I - IV) measured using data from linked National Cancer Registration and Analysis Service (NCRAS) records 6. Non-screen detected lung cancer diagnoses and stage (binary: yes/no), histological sub-type (categorical: small cell, adenocarcinoma, squamous cell, NSCLC NOS and other) and stage (I - IV) measured using data from linked NCRAS records data 7. Proportion of eligible (non-randomised) individuals in the household who attend all invited LCS appointments within the follow-up period of the randomised participant measured using patient LCS records. The outcome will be binary (yes/no) as collected on routine LCS databases. Household members who have returned an ‘opt-out’ form will not be included. 8. Intervention delivery rate, defined as the number of successful navigator contacts within the eligible participant population,

Countries

England, United Kingdom

Contacts

Public ContactJodie Chalmers
jodie.chalmers@nbt.nhs.uk+44 (0)1174147912

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026