- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Elizabeth Bailey
- Номер телефона: +441483 300800
- Электронная почта: assurance@surrey.ac.uk
Места учебы
-
-
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Leicester, Соединенное Королевство
- University Hospitals of Leicester NHS Trust
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Скрининг
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Другой: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of FIT test completed
Временное ограничение: Completion within 3 months of patient navigation intervention
|
Completion of FIT test
|
Completion within 3 months of patient navigation intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Feasibility of delivering patient navigation (survey)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
|
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Acceptability of receiving patient navigation (Interviews)
Временное ограничение: 0-5 months post patient navigation
|
Semi-structured interviews with service users who received patient navigation
|
0-5 months post patient navigation
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Robert Kerrison, PhD, University of Surrey
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- SPON 2026-06
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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