Breast CancerEQUITANCT06981182
EQUITA - A Feasibility Trial of a Faith-placed Intervention to Increase Screening Uptake in Black Adults
A study testing Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities. in people with Breast Cancer and Bowel Cancer, run by University of Sunderland at 3 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Bowel Cancer, Cervical Cancer
- What is being tested?
- Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Sep 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites
University of Glasgow
Glasgow, Scotland, G12 8QQ
Farhin Ahmed, 0191 515 300, Farhin.Ahmed@sunderland.ac.uk
Leeds Beckett University
Leeds, LS1 3HE
Farhin Ahmed, 0191 515 300, Farhin.Ahmed@sunderland.ac.uk
University of Sunderland
Sunderland, SR1 3SD
Farhin Ahmed, 0191 515 300, Farhin.Ahmed@sunderland.ac.uk
About this study
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
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.
Read the 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:
- 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.
- Being tested
- Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities.
- Keywords
- Cancer screening, Breast Cancer, Bowel Cancer, Cervical Cancer, Abdominal Aortic Aneurysm, Faith-placed intervention, Black adults, Randomised Controlled Trial, Feasibility study, Faith-based
- Medical subject headings
- Breast Neoplasms, Intestinal Neoplasms, Uterine Cervical Neoplasms, Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 10 - 18
Secondary outcomes (10)
Attitude
Change in attitude of barriers perceived towards screening programmes. This outcome is self-reported by participant
Measured: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention
Religious Health Fatalism Questionnaire (RHFQ)
A questionnaire will be given to participants to test how religious beliefs influence health beliefs and willingness to obtain screening and medical treatments.
RHFQ includes 8 statements that are answered on 5-point Likert scale: 1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree Total scores range from 8 to 40. Higher scores indicate higher levels of religious fatalism, thus a lower willingness to attend screening due to religious beliefs.
Measured: Baseline (prior to intervention)
Modesty
The modesty measure for EQUITA is designed to assess the influence of cultural and religious values related to bodily privacy on cancer screening behaviours. Using two previously validated scales, the Modesty Measure for Muslim Women (MMM-W) by Padela et al. (2019) and Andrews' (2011) Modesty Scale.
The measure comprises six items, rated on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). Higher scores indicate stronger modesty beliefs related to bodily privacy. Scores will be analysed to examine the relationship between modesty and screening intentions or behaviours.
Measured: Baseline (prior to intervention)
Socio-demographic Descriptions
Participant characteristics, such as age, location, education level, ethnicity, professional occupation and marital status, will be recorded and used for descriptive statistics ad subgroup analysis.
Measured: Baseline (prior to intervention)
Cancer knowledge questions adapted from Cancer Awareness Measures (CAM) by Cancer Research UK
The measure knowledge of symptoms and risk factors of breast, cervical, and bowel cancer, awareness of the NHS screening programmes including age of invitation and frequency, a question including 22 barriers to screening ranging from emotional to practical barriers, attitudinal change to screening, self-reported screening uptake, intention, preparedness, and sociodemographic descriptors. The CAM captures participants' socioeconomic status by measuring level of education, living arrangements (owning outright, mortgage, renting from local authority/privately, squatting, other), and their postcode. The questionnaire will be administered online through Qualtrics (a telephone option will also be offered). Most items are multiple-choice or Likert-scale. Higher scores indicate greater cancer knowledge. Total scores and subdomain scores will be compared over time.
Measured: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention
AAA Knowledge Screening
Questions assessing knowledge and awareness will be adapted from Suckow et al 2016These survey items, previously trialled in the UK and informed by other studies, include multiple-choice questions with single-choice responses on AAA definition, risk factors, detection methods, and the screening process. Correct responses will be summed. Higher scores indicate greater knowledge. Items are based on validated UK questionnaires.
Measured: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention
Self-reported screening uptake
Change in the number of participants who obtained screening following the intervention. This outcome is self-reported by participants. This (Yes/No) outcome will be assessed at follow-up. Uptake will be compared to baseline to assess the intervention's impact.
Measured: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention
Actual screening uptake
Screening data from the National Health Services (NHS) will be analysed to examine the change in the number of participants who obtained screening following the intervention.
Measured: 6 months post- intervention
Quality of life measure
Intervention participants will be asked to fill EQ-5D-5L questionnaires, which comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems and 5 = extreme problems. Scores can be reported by individual dimension or as an index value (range: -0.281 to 1.0, where 1 = full health). Higher index scores represent better health-related quality of life.
Measured: Baseline (prior to intervention)
Multimorbidity measure
Measures multimorbidity based on a disease count approach, which consists of a list of 35 conditions to be asked which they have, as well as the option to include any other conditions. The total number of conditions reported will be counted. Higher scores indicate greater multimorbidity.
Measured: Baseline (prior to intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Sep 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist control
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sunderland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Floor Christie-de Jong, University of Sunderland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981182
- Sponsor's protocol ID
- NIHR 164073
- Other IDs
- 164073
- Acronym
- EQUITA
- Status last verified
- May 2025
- First submitted
- 17 Apr 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be publicly available, but may be shared upon reasonable request subject to data use agreements and ethics approval
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06981182
- Acronym / sponsor ID
- EQUITA / NIHR 164073
- Keywords
- Cancer screening, Breast Cancer, Bowel Cancer, Cervical Cancer, Abdominal Aortic Aneurysm, Faith-placed intervention, Black adults, Randomised Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of SunderlandUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Waitlist control
| Arm | Type | Receives |
|---|---|---|
| In-person Workshop | Experimental | Other: Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities.Participants will attend a co-produced 2-hour workshop delivered at a church at either sites; North East of England, Leeds and Scotland. |
| 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. |
Who may qualify
- Ages
- 25 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Other | In-person Workshop |
Primary outcome
Narrative description of feasibility
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- NIHR Funding AwardLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will not be publicly available, but may be shared upon reasonable request subject to data use agreements and ethics approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities. in people with Breast Cancer and Bowel Cancer, run by University of Sunderland at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Floor Christie-de Jong (0191 5153445, floor.christie@sunderland.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Narrative description of feasibility (time frame: Month 1 - 24). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.