Menu
Not yet recruiting NCT06981182

EQUITA - A Feasibility Trial of a Faith-placed Intervention to Increase Screening Uptake in Black Adults

No phase Interventional Breast Cancer Bowel Cancer Cervical Cancer Abdominal Aortic Aneurysm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities..
Who it may be relevant to
Registry conditions: Breast Cancer, Bowel Cancer, Cervical Cancer, Abdominal Aortic Aneurysm. Basic parameters: 25 years — 74 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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

Primary outcome measures

  • Narrative description of feasibility [Time frame: Month 1 - 24]
  • (1) Number of churches recruited into the study [Time frame: Month 3 - 7]
  • (2) Number of churches that consent to randomisation will be documented [Time frame: Month 3 - 7]
  • (3) Number of participants recruited [Time frame: Month 3 - 7]
  • (4) Distribution of recruited participants across age groups and screening programmes [Time frame: Month 7 - 13]
  • (5) Proportion of participants retained at 3-month follow up [Time frame: Month 10 - 15]
  • (6) Acceptability of the informed consent procedures to participants [Time frame: Month 10 - 18]
  • (7) Suitability of data collection tools [Time frame: Month 10 - 21]
  • (8) Proportion of participants providing consent to provide access to NHS screening data [Time frame: Month 13 - 19]
  • (9) Feasibility of accessibility of NHS screening data [Time frame: Month 13 - 19]
Secondary outcome measures (10)
  • Attitude [Time frame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention]
  • Religious Health Fatalism Questionnaire (RHFQ) [Time frame: Baseline (prior to intervention)]
  • Modesty [Time frame: Baseline (prior to intervention)]
  • Socio-demographic Descriptions [Time frame: Baseline (prior to intervention)]
  • Cancer knowledge questions adapted from Cancer Awareness Measures (CAM) by Cancer Research UK [Time frame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention]
  • AAA Knowledge Screening [Time frame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention]
  • Self-reported screening uptake [Time frame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention]
  • Actual screening uptake [Time frame: 6 months post- intervention]
  • Quality of life measure [Time frame: Baseline (prior to intervention)]
  • Multimorbidity measure [Time frame: Baseline (prior to intervention)]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United Kingdom · 3 centers
  • University of Glasgow — Glasgow
  • Leeds Beckett University — Leeds
  • University of Sunderland — Sunderland

Identifiers

NCT: NCT06981182 · NIHR 164073 · 164073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗