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

NCT06981182 | Not Yet Recruiting

• 2 other identifiers: NIHR 164073164073
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer; Bowel Cancer; Cervical Cancer; Abdominal Aortic Aneurysm

Keywords

Cancer screening; Breast Cancer; Bowel Cancer; Cervical Cancer; Abdominal Aortic Aneurysm; Faith-placed intervention; Black adults; Randomised Controlled Trial; Feasibility study; Faith-based

Outcome Measures

Primary Outcomes (12)

• Narrative description of feasibility

  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.

  Month 1 - 24

• (1) Number of churches recruited into the study

  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.

  Month 3 - 7

• (2) Number of churches that consent to randomisation will be documented

  A log will document the number of churches that agree to be randomised, including consent status and allocation group.

  Month 3 - 7

• (3) Number of participants recruited

  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.

  Month 3 - 7

• (4) Distribution of recruited participants across age groups and screening programmes

  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).

  Month 7 - 13

• (5) Proportion of participants retained at 3-month follow up

  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.

  Month 10 - 15

• (6) Acceptability of the informed consent procedures to participants

  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

  Month 10 - 18

• (7) Suitability of data collection tools

  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.

  Month 10 - 21

• (8) Proportion of participants providing consent to provide access to NHS screening data

  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

  Month 13 - 19

• (9) Feasibility of accessibility of NHS screening data

  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.

  Month 13 - 19

• (10) Number of participants who become peer facilitators and time taken to train them

  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.

  Month 4 - 13

• (11) Acceptability of the intervention to participants

  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.

  Month 10 - 18

Secondary Outcomes (10)

• 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

Study Arms (2)

In-person Workshop

EXPERIMENTAL

Participants will attend a co-produced 2-hour workshop delivered at a church at either sites; North East of England, Leeds and Scotland.

Other: Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities.

No workshop

NO INTERVENTION

The control group will have regular church sessions and will be wait listed. They will receive the intervention after data collection is complete.

Interventions

Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities. OTHER

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 that tackle barriers to screening and that are present in the existing IMCAN and PROCAN-B interventions, if the PICE group believe these are helpful, such as health education about breast, cervical, bowel and AAA screening delivered by a healthcare provider with an opportunity to ask questions, personal testimonials through survivors' stories, as well as members of the community discussing experiences of screening, and utilising community and peer support and religious leaders.

In-person Workshop

Eligibility Criteria

• Age: 25 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sunderland: lead
• University of Glasgow: collaborator

Study Sites (3)

University of Glasgow

Glasgow, Scotland, G12 8QQ, United Kingdom

Location

Leeds Beckett University

Leeds, LS1 3HE, United Kingdom

Location

University of Sunderland

Sunderland, SR1 3SD, United Kingdom

Location

Related Links

• NIHR Funding Award

MeSH Terms

Conditions

Breast Neoplasms; Intestinal Neoplasms; Uterine Cervical Neoplasms; Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Central Study Contacts

Floor Christie-de Jong

CONTACT

0191 5153445; floor.christie@sunderland.ac.uk

Farhin Ahmed

CONTACT

0191 515 3000; Farhin.Ahmed@sunderland.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Public Health for Medicine

Model Details: Waitlist control

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: May 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)