- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07721740
Using Patient Navigation to Promote Bowel Screening in AAA Attendees. (TET BETA)
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.
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Elizabeth Bailey
- Numéro de téléphone: +441483 300800
- E-mail: assurance@surrey.ac.uk
Lieux d'étude
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Leicester, Royaume-Uni
- University Hospitals of Leicester NHS Trust
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Patient Navigation
Eligibility: Men who have a negative AAA result, indicate that they have not completed their most recent bowel screening and are happy to discuss this further. Intervention: A 2 minute Patient Navigation intervention (discussion regarding barriers to completing bowel cancer screening) |
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of FIT test completed
Délai: Completion within 3 months of patient navigation intervention
|
Completion of FIT test
|
Completion within 3 months of patient navigation intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Feasibility of delivering patient navigation (survey)
Délai: 0-5 months post patient navigation delivery
|
Survey with those who delivered patient navigation.
Survey contains 7 items: 2 demographic questions, 2 items on a 3-point Likert scale (with option to provide further detail in open text), 2 open text responses, and one dichotomous item (Yes/No).
The Likert scales are scored where 1 is low and 3 is high.
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0-5 months post patient navigation delivery
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Feasibility of delivering patient navigation (Interviews)
Délai: 0-5 months post patient navigation delivery
|
Semi-structured interviews with those who delivered patient navigation
|
0-5 months post patient navigation delivery
|
|
Acceptability of receiving patient navigation (Survey)
Délai: 0-5 months post patient navigation
|
Survey with service users who received patient navigation.
Survey contains 12 items: 4 demographic questions, 5 items on a 5-point Likert scale, and 3 open text responses.
The Likert scales are scored where 1 is high and 5 is low.
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0-5 months post patient navigation
|
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Acceptability of receiving patient navigation (Interviews)
Délai: 0-5 months post patient navigation
|
Semi-structured interviews with service users who received patient navigation
|
0-5 months post patient navigation
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Robert Kerrison, PhD, University of Surrey
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- SPON 2026-06
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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