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Not yet recruiting NCT07721740

Using Patient Navigation to Promote Bowel Screening in AAA Attendees.

No phase Interventional Bowel Cancer Screening

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Navigation conversation.
Who it may be relevant to
Registry conditions: Bowel Cancer Screening. Basic parameters: from 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Testing the Efficacy, Feasibility, Acceptability and Cost-effectiveness of Patient Navigation to Promote Bowel Cancer Screening Participation Among Non-responders Attending Abdominal Aortic Aneurysm (AAA) Screening: A Multi-centre Pilot Study.

Overview

The goal of this single-arm, multi-centre feasibility study is to assess the efficacy, feasibility and acceptability of implementing patient navigation across Abdominal Aortic Aneurysm (AAA) screening services in England to increase uptake of bowel cancer screening. The main questions it aims to answer are: * Do service users complete a bowel cancer screening within three months of receiving patient navigation? * Do service deliverers consider patient navigation as feasible to implement in practice? * Do service users consider patient navigation acceptable to receive during their AAA appointment? Participants will be asked to discuss bowel screening with AAA practitioners (patient navigation). Follow-up surveys and interviews will be conducted with those that delivered the intervention and with those that received it.

Detailed description

Bowel cancer is a leading cause of cancer-related mortality in England. Biennial Faecal Immunochemical Test (FIT) screening can reduce bowel cancer-related deaths by detecting cases before symptoms develop. However, uptake remains suboptimal, particularly among men. Evidence from a single-centre study in Scotland suggests that a brief intervention, akin to patient navigation, delivered to men attending routine abdominal aortic aneurysm (AAA) screening appointments, can facilitate participation.

The overarching aim of this study is to evaluate the efficacy, feasibility, acceptability and cost-effectiveness of implementing patient navigation intervention across AAA screening services in England.

This study will be a single-arm, multi-centre feasibility study that will be conducted across five AAA screening centres in England, i.e. Leicester, Birmingham and Black Country, London, West Yorkshire, and Somerset and North Devon. Over a three-month period (August-November 2026), AAA screening practitioners will deliver patient navigation to a sample of approximately 4190 men, aged 65+ years, who attend AAA screening and self-report as bowel screening non-responders.

The primary outcome of the study is completion of a FIT kit within three months of the AAA appointment. Secondary outcomes include the feasibility, acceptability and cost-effectiveness of the intervention.

The study comprises three Work Packages:

Work Package 1 will be the single-arm, multi-centre feasibility study. The outcome will be the completion of a bowel cancer screening kit, providing preliminary evidence of efficacy.

Work Package 2 will evaluate feasibility from the service provider perspective, using surveys (Workstream 2a) and interviews (Workstream 2b) with AAA service providers.

Work Package 3 will assess acceptability from the service user perspective, using surveys (Workstream 3a) and interviews (Workstream 3b) with those who received the intervention during the study period.

The findings will be used to inform an implementation toolkit as part of a national strategy to improve the uptake of bowel screening.

Interventions

  • Other Patient Navigation conversation
    Brief 1.5-2 minute conversation to discuss barriers and solutions to why have not completed most recent bowel screening. Offer of third party request or information to contact screening service.

Primary outcome measures

  • Number of FIT test completed [Time frame: Completion within 3 months of patient navigation intervention]
Secondary outcome measures (4)
  • Feasibility of delivering patient navigation (survey) [Time frame: 0-5 months post patient navigation delivery]
  • Feasibility of delivering patient navigation (Interviews) [Time frame: 0-5 months post patient navigation delivery]
  • Acceptability of receiving patient navigation (Survey) [Time frame: 0-5 months post patient navigation]
  • Acceptability of receiving patient navigation (Interviews) [Time frame: 0-5 months post patient navigation]

Eligibility criteria

Inclusion criteria

  • Men aged 65 years and above
  • Attending an AAA screening appointment
  • Have not completed their most recent bowel screening
  • Agree to discuss bowel screening further

Exclusion criteria

  • Men aged <65years
  • Those who do not attend their AAA screening appointment
  • Have completed their most recent bowel screening
  • Do not agree to discuss bowel screening further
  • Those who received a positive AAA result in their appointment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United Kingdom · 1 center
  • University Hospitals of Leicester NHS Trust — Leicester

Identifiers

NCT: NCT07721740 · SPON 2026-06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗