EQUITA - A Feasibility Trial of a Faith-placed Intervention to Increase Screening Uptake in Black Adults
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities..
- Кому может быть актуально
- Состояния в реестре: Breast Cancer, Bowel Cancer, Cervical Cancer, Abdominal Aortic Aneurysm. Базовые параметры: 25 лет — 74 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Великобритания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
EQUITy in Black Adult Health (EQUITA) - a Randomised Feasibility Trial of a Co-produced and Faith-placed Intervention to Increase Uptake of Breast, Cervical, Bowel, and AAA Screening in the North East of England, Leeds and Scotland
Обзор
The goal of this randomised feasibility trial is to examine feasibility and acceptability of a co-produced and faith-placed intervention to increase uptake of breast, cervical, bowel, and abdominal aortic aneurysm (AAA) screening among Black communities in the North East of England, Leeds and Scotland, United Kingdom (UK). Participants will be invited to attend a two-hour workshop at each of the three study sites and will be randomly assigned to either the intervention group or the control group. This 24-month feasibility study will inform the development of a full-scale randomised-controlled trial co-produced for Black people that uses culturally appropriate messages that support screening for early diagnosis in this underserved group.
Подробное описание
Over 2.4 million Black, Black British, Black Caribbean or African people live in the UK Black community, where lower screening rates place them at a higher risk of death due to lack of early diagnosis and provision of effective early treatment. Population health screening is largely under-researched in Black communities in the UK. Few studies have been conducted focusing on Black people and national screening programmes.
The EQUITA study builds on the IMCAN (Improving Muslim Women's CANcer Screening Uptake), and PROCAN-B ((Early diagnosis of PROstate CANcer for Black men) studies by using the same community-centred and participatory approach to apply a whole-community, multi-screening strategy to encourage uptake of breast, bowel, cervical, and AAA screening among Black communities. The intervention will retain the core elements of the participatory approach, including the Community Recruitment Leads on the research team, Public Involvement and Community Engagement (PICE) group for co-production, trained peer-facilitators, and faith-based engagement. The structured workshop format, which has demonstrated feasibility and acceptability in previous studies, will be tailored in collaboration with Black communities to ensure cultural relevance.
The study consists of six objectives with aligned work packages:
1. Can the existing intervention be adapted in partnership with a PICE group to improve engagement with breast, cervical, bowel, and AAA screening programmes in the Black community? 2. Can a two-arm cluster-randomised feasibility trial of the peer-led intervention be delivered in three sites: Leeds, North East of England and Scotland? 3. What are the perspectives of participants, peer facilitators, and key stakeholders on intervention and trial methodology, acceptability, and intervention implementation? 4. What is the feasibility trial's performance on key parameters and predefined progression criteria? 5. Is it feasible to conduct an economic evaluation to assess the cost-effectiveness of the intervention? 6. What are effective data dissemination strategies, and can the next phase be prepared by designing a study protocol for a definitive trial and logic model for implementation?
This feasibility trial will involve delivering a 2-hour workshop to 300 Black people (females aged 25-74 and males 50-74) in churches in Scotland, North East of England, and Leeds, who are either not or partially up to date with the screening they are eligible for. Participants will be randomly allocated to either the intervention or control group at each site. A process evaluation, including focus groups and stakeholder interviews, will guide modifications to the trial and intervention.
Вмешательства
- Другое Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities.
The intervention includes a two-hour workshop, delivered in person to the entire congregation, that aims to promote the uptake of breast, cervical, bowel, and AAA screening among Black communities in the North East of England, Leeds and Scotland. However, we will only include effectiveness data (i.e., surveys and screening uptake) from those who meet the study eligibility criteria. The intervention will be a peer-led, multidimensional community workshop. It will incorporate multiple components t
Первичные конечные точки
- Narrative description of feasibility [Срок оценки: Month 1 - 24]
- (1) Number of churches recruited into the study [Срок оценки: Month 3 - 7]
- (2) Number of churches that consent to randomisation will be documented [Срок оценки: Month 3 - 7]
- (3) Number of participants recruited [Срок оценки: Month 3 - 7]
- (4) Distribution of recruited participants across age groups and screening programmes [Срок оценки: Month 7 - 13]
- (5) Proportion of participants retained at 3-month follow up [Срок оценки: Month 10 - 15]
- (6) Acceptability of the informed consent procedures to participants [Срок оценки: Month 10 - 18]
- (7) Suitability of data collection tools [Срок оценки: Month 10 - 21]
- (8) Proportion of participants providing consent to provide access to NHS screening data [Срок оценки: Month 13 - 19]
- (9) Feasibility of accessibility of NHS screening data [Срок оценки: Month 13 - 19]
Вторичные конечные точки (10)
- Attitude [Срок оценки: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention]
- Religious Health Fatalism Questionnaire (RHFQ) [Срок оценки: Baseline (prior to intervention)]
- Modesty [Срок оценки: Baseline (prior to intervention)]
- Socio-demographic Descriptions [Срок оценки: Baseline (prior to intervention)]
- Cancer knowledge questions adapted from Cancer Awareness Measures (CAM) by Cancer Research UK [Срок оценки: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention]
- AAA Knowledge Screening [Срок оценки: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention]
- Self-reported screening uptake [Срок оценки: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention]
- Actual screening uptake [Срок оценки: 6 months post- intervention]
- Quality of life measure [Срок оценки: Baseline (prior to intervention)]
- Multimorbidity measure [Срок оценки: Baseline (prior to intervention)]
Критерии участия
Критерии включения
- Members of participating churches (North East of England, Leeds, Scotland)
- Self-identify as Black,
- Female aged 25-74,
- Male aged 50-74,
- Not up to date with all screening tests for which they are eligible, e.g., women who are up to date with one form of screening (e.g., breast) will be eligible for recruitment if they are not up to date with others (e.g., cervical or bowel).
Критерии исключения
- Not a member of participating churches (North East of England, Leeds, Scotland).
- Individuals who do not self-identify as Black
- Do not self-identity as Black
- Females aged outside the range of 25-74
- Males aged outside the range of 50-74.
- Individuals who are up to date with all screening tests for which they are eligible.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Другое
Центры проведения
Великобритания · 3 центра
- University of Glasgow — Glasgow
- Leeds Beckett University — Leeds
- University of Sunderland — Sunderland
Идентификаторы
NCT: NCT06981182 · NIHR 164073 · 164073