- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Elizabeth Bailey
- Phone Number: +441483 300800
- Email: assurance@surrey.ac.uk
Study Locations
-
-
-
Leicester, United Kingdom
- University Hospitals of Leicester NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of FIT test completed
Time Frame: Completion within 3 months of patient navigation intervention
|
Completion of FIT test
|
Completion within 3 months of patient navigation intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of delivering patient navigation (survey)
Time Frame: 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.
|
0-5 months post patient navigation delivery
|
|
Feasibility of delivering patient navigation (Interviews)
Time Frame: 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)
Time Frame: 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.
|
0-5 months post patient navigation
|
|
Acceptability of receiving patient navigation (Interviews)
Time Frame: 0-5 months post patient navigation
|
Semi-structured interviews with service users who received patient navigation
|
0-5 months post patient navigation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Robert Kerrison, PhD, University of Surrey
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SPON 2026-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bowel Cancer Screening
-
University of HullGateshead Health NHS Foundation Trust; Bradford Teaching Hospitals NHS Foundation...Active, not recruitingBowel Cancer ScreeningUnited Kingdom
-
Morehouse School of MedicineRecruitingColorectal Cancer Screening | Bowel Cleansing for ColonoscopyUnited States
-
Nanfang Hospital, Southern Medical UniversityRecruitingBowel Preparation Solutions | Colonoscopy | Colorectal Cancer ScreeningChina
-
Joseph SpataroHappy Colon FoodsCompletedAssessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With LaxativesBowel Preparation for Colonoscopy | Colon Cancer Screening | Bowel Preparation, Efficacy, Tolerability, SafetyUnited States
-
Sheffield Teaching Hospitals NHS Foundation TrustCompletedAnalgesia | Colonoscopy | Bowel Cancer Screening | EntonoxUnited Kingdom
-
Pamukkale UniversityThe Scientific and Technological Research Council of TurkeyActive, not recruitingCancer Screening | Men's Health ScreeningTurkey (Türkiye)
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); Massachusetts League of Community Health Centers and other collaboratorsEnrolling by invitationTobacco Cessation | Cervical Cancer Screening | Breast Cancer Screening | Colon Cancer ScreeningUnited States
-
Lanxi Hospital of Traditional Chinese MedicineZhejiang Cancer Hospital; Zhejiang Chinese Medical UniversityWithdrawn
-
Beth Israel Deaconess Medical CenterNational Cancer Institute (NCI)Completed
-
Johns Hopkins UniversityState of MarylandCompleted
Clinical Trials on Patient Navigation conversation
-
University of Colorado, DenverDenver Health and Hospital Authority; Rocky Mountain Human Services; El Grupo...Completed
-
University of UtahUniversity of PittsburghCompletedPregnancy Related | Pregnancy, High Risk | Opioid-Related DisordersUnited States
-
Massachusetts General HospitalAmerican Cancer Society, Inc.CompletedTobacco Use | Lung Cancer | HomelessnessUnited States
-
Instituto Nacional de Ciencias Medicas y Nutricion...Global Cancer InstituteCompleted
-
Massachusetts General HospitalCompleted
-
Emory UniversityCompletedEnd-Stage Renal DiseaseUnited States
-
The Netherlands Cancer InstituteUnknown
-
Massachusetts General HospitalCompletedColorectal CancerUnited States
-
Boston Medical CenterCompleted
-
Medical University of ViennaMedical University of Lodz; Servicio Madrileño de Salud, Madrid, Spain; Universitat... and other collaboratorsRecruitingCancerAustria, Greece, Poland, Spain