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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Narrative description of feasibility
研究概览
简要总结
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.
详细描述
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:
- 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?
- 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?
- What are the perspectives of participants, peer facilitators, and key stakeholders on intervention and trial methodology, acceptability, and intervention implementation?
- What is the feasibility trial's performance on key parameters and predefined progression criteria?
- Is it feasible to conduct an economic evaluation to assess the cost-effectiveness of the intervention?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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-
- •Individuals who are up to date with all screening tests for which they are eligible.
结局指标
主要结局
Narrative description of feasibility
时间窗: Month 1 - 24
Using a mixed-methods approach and summarised as a narrative synthesis according to the progression criteria described below (Measures 1 - 11). Key feasibility domains include: time required for study setup and delivery; recruitment and retention of churches and participants; training and retention of peer facilitators; intervention delivery and adherence; data completeness and quality; and acceptability of procedures. Data sources will include recruitment and training logs, screening and consent forms, follow-up tracking sheets, and participant feedback surveys. Challenges and facilitators encountered will be documented in field notes by the study team. Quantitative data will be summarised descriptively (counts, percentages), and qualitative data will be thematically analysed. Findings will be assessed against pre-specified progression criteria to inform the viability of a future definitive trial.
(1) Number of churches recruited into the study
时间窗: Month 3 - 7
The number of churches recruited will be recorded using a site recruitment log maintained by the study team. This log will record church name, date of agreement to participate, and contact details of church representatives. Descriptive statistics (e.g., counts and percentages) will be used to summarise the data.
(2) Number of churches that consent to randomisation will be documented
时间窗: Month 3 - 7
A log will document the number of churches that agree to be randomised, including consent status and allocation group.
(3) Number of participants recruited
时间窗: Month 3 - 7
Participant screening and enrolment at baseline will be tracked in a participant recruitment log that includes date of screening, eligibility status, consent obtained (yes/no), and enrolment status. Numbers will be summarised using counts and percentages to assess recruitment feasibility.
(4) Distribution of recruited participants across age groups and screening programmes
时间窗: Month 7 - 13
Baseline demographic data (age, gender, and NHS screening eligibility) collected via participant questionnaires will be used to determine the distribution of participants across the four targeted screening programmes (cervical, breast, bowel, and AAA).
(5) Proportion of participants retained at 3-month follow up
时间窗: Month 10 - 15
A follow-up tracking log will record all participants due for 3-month follow-up, the mode of follow-up contact (e.g., phone, email), and whether data collection was completed. Retention rates will be calculated as the proportion of enrolled participants who complete the follow-up assessment.
(6) Acceptability of the informed consent procedures to participants
时间窗: Month 10 - 18
Acceptability of the informed consent process will be explored through qualitative interviews and/or focus groups conducted as part of the process evaluation. These discussions will examine participants' experiences of the consent process, including clarity of information, understanding of what participation involves, and overall satisfaction with how consent was obtained
(7) Suitability of data collection tools
时间窗: Month 10 - 21
Suitability of the data collection tools will be assessed through a mixed-methods approach. Completion rates will be calculated using descriptive statistics to evaluate the feasibility of administering the tools. In addition, feedback on the acceptability and clarity of the data collection measures will be gathered through qualitative methods (e.g. focus groups or interviews) and analysed thematically as part of the process evaluation.
(8) Proportion of participants providing consent to provide access to NHS screening data
时间窗: Month 13 - 19
The number of participants who explicitly consented to NHS data access will be recorded in the consent form and extracted into the study's NHS data access log. Percentages will be calculated relative to total enrolment. This will also be explored qualitatively
(9) Feasibility of accessibility of NHS screening data
时间窗: Month 13 - 19
Data request forms sub mitted to NHS and matched datasets returned will be tracked in a secure data access log. The proportion of successful data matches will be calculated in relative to total for unsuccessful data request submitted to NHS.
(10) Number of participants who become peer facilitators and time taken to train them
时间窗: Month 4 - 13
A training participation log will record the number of enrolled participants who registered for and attended peer facilitator training sessions. The number retained as peer facilitators at 3-month follow-up will also be recorded. Counts and retention percentages will be calculated. Dates of training registration, initiation, and completion will be documented in the training log. Time intervals will be calculated to determine the proportion trained within the target timeframe of 2-3 months.
(11) Acceptability of the intervention to participants
时间窗: Month 10 - 18
Qualitative feedback on the intervention will be collected post-intervention through focus groups and interviews with both intervention and control participants. Feedback will be summarised thematically.
次要结局
- Attitude(Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention)
- Religious Health Fatalism Questionnaire (RHFQ)(Baseline (prior to intervention))
- Modesty(Baseline (prior to intervention))
- Socio-demographic Descriptions(Baseline (prior to intervention))
- Cancer knowledge questions adapted from Cancer Awareness Measures (CAM) by Cancer Research UK(Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention)
- AAA Knowledge Screening(Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention)
- Quality of life measure(Baseline (prior to intervention))
- Self-reported screening uptake(Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention)
- Actual screening uptake(6 months post- intervention)
- Multimorbidity measure(Baseline (prior to intervention))
研究者
Floor Christie-de Jong
Associate Professor in Public Health for Medicine
University of Sunderland