Improving Muslim Women's Uptake of Cancer Screening (IMCAN)

NCT06106165 | Recruiting

• 1 other identifier: EDDPJT-May22\100030
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this non-randomised trial is to test how a workshop that includes religiously-tailored messages can help increase the uptake of breast, colorectal and cervical cancer screening among Muslim women in North East England and Scotland. The results of this trial will inform the development of a full-scale randomised-controlled trial. Participants in this study will be asked to take part in a two-hour workshop, deliver either online or in-person.

Conditions

Breast Cancer; Bowel Cancer; Cervical Cancer

Keywords

Cancer screening; Breast Cancer; Bowel Cancer; Cervical Cancer; Faith-based intervention; Muslim women

Outcome Measures

Primary Outcomes (13)

• Narrative description of feasibility

  The primary outcome of the project will be a narrative description of study feasibility, including recruitment and retention, protocol adherence and stakeholder acceptability. The primary outcome will be assessed using a mixed methods approach and assessed according the progression criteria, as described below.

  12 months

• Recruitment feasibility

  Determine how many women accept the invitation to participate in the study and to estimate eligibility, recruitment and refusal rates. This will be assessed using project monitoring data maintained by the research team which logs in detail all study data, including number of people, time, missing data, and cost where relevant. Eligibility rate: Calculated as the number of participants screened/number of participants eligible x100% Recruitment rate: Calculated as the number of enrolled participants/number of eligible participants x 100% We will report recruitment and retention rates with 90% confidence intervals. Recruitment and retention rates will be summarised in relation to baseline characteristics, and differences in retention rates will be assessed using logistic regression methods.

  Baseline, 5 months, 7 months, 12 months

• Screening status of participants and the proportion of participants who were partially/not up to date with screening

  Estimate the screening-non-responder rate. Non-responder rate: Calculated as the number of enrolled participants who were screening non-responders/number of eligible participants x 100%

  Baseline

• Retention rate

  Estimate loss to follow up/retention rate. This will be assessed using project monitoring data Retention rate: Calculated as the number of participants who complete the 12 months follow up/number of participants in the intervention x100% This data will be compared for non-responders and partial responders.

  6 months, 12 months

• Peer educator recruitment feasibility

  Number of women who accepted the invitation to become peer educators, and the number of peer educators retained at 12 months. This will be assessed using project monitoring data. Peer-educator recruitment rate: Calculated as the number of enrolled peer-educators/number of eligible peer-educators x 100% Peer-educator retention rate: calculated as the number of peer-educators at 12 months/number of peer-educators recruited x 100%

  baseline, 12 months

• Feasibility of obtaining screening data

  Whether the research team was able to obtain screening records for participants in all study location, and the proportion of participants who gave consent to access their screening records

  12 months

• Questionnaire response rate

  The proportion of participants responding to questionnaires at baseline, 6 months and 12 months.

  Baseline, 6 months, 12 months

• Feasibility of measuring secondary outcomes

  Measure key secondary outcome measures including behavioural intention proxies, and feasibility of self-reported data, missing data, estimates, variances and 95% CIs for any comparisons. Baseline and follow up data Data will be assessed in relation to each of the 3 different types of screening, as well as generally, to ensure we capture whether the intervention has a differential impact on different screening types. We will also aim to compare behavioural change and self-reported data with the actual NHS screening data. Participants' scores on outcome scales, and changes over time, will be reported using descriptive methods. Paired t-tests, or non-parametric alternatives, will be used to estimate changes over time, with 90% confidence intervals. Correlations between baseline and follow-up measures will be reported with 90% confidence intervals.

  Baseline, 6 months, 12 months

• Difference on key domains between intervention modalities (online/face to face)

  Comparison of measures on key domains for trial parameters will provide insight into the feasibility of the two different modes of delivery. This will be inspected using project monitoring data baseline and follow up measures. Including: eligibility rate, recruitment rate, retention rate, all measures non-responders/attenders and missing data Visual inspection of trends and descriptive data will be used to establish whether comparisons between modalities is feasible.

  Baseline, 6 months, 12 months

• The acceptability of the study engagement process to peer-educators

  Qualitative exploration of the acceptability of the process of recruitment, co-design phase, training, experiences and delivery of intervention. Qualitative process evaluation focus groups with peer-educators. Including: experiences of co-design phase, experiences of recruitment of peer-educators, experiences of training, experiences of delivery of the intervention, language and use of interpreters, and perspectives on the intervention and study.

  12 months

• The acceptability of the intervention and its implementation to participants and stakeholders, including intervention components and delivery mode (online/face-to-face)

  Qualitative exploration of the acceptability of the intervention and its delivery with participants and key stakeholders. Qualitative process evaluation focus groups with participants and interviews with stakeholders. This explores the following: content of the intervention, delivery mode of the intervention (face-to-face/online), delivery of the intervention (peer-educators, health care provider, religious perspective, personal testimonials), and experience and perspectives of taking part in the intervention

  12 months

• The acceptability of data collection methods used to participants and stakeholders

  Qualitative exploration of the acceptability of the data collection methods and secondary outcome measures with participants and key stakeholders. Qualitative process evaluation focus groups with participants and interviews with stakeholders Including: invitation to participate , recruitment processes, consent taking, baseline and follow-up secondary outcome measures, engagement in baseline and follow-up processes, and willingness to be randomised.

  12 months

• Adherence to protocol

  Explore qualitatively protocol adherence and barriers and enablers to key stakeholders such as research staff and collaborators. Qualitative process evaluation interviews with research staff and collaborators.

  12 months

Secondary Outcomes (8)

• Religious health fatalism questionnaire (RHFQ)

  Baseline

• Modesty

  Baseline

• Sociodemographic descriptors

  Baseline

• Cancer knowledge questions adapted from Cancer Awareness Measures (CAM) by Cancer Research UK

  baseline, 6 months and 12 months

• Cancer screening behaviour

  baseline, 6 months and 12 months

Study Arms (2)

In-person delivery

EXPERIMENTAL

Participants will attend the workshops in a mosque or community centre.

Other: In-person peer-led faith-based intervention to encourage breast, bowel, and cervical screening uptake among Muslim women

Online delivery

EXPERIMENTAL

Participants will join the workshops via a web conferencing platform The content of the online workshops is identical to the content of in-person workshops.

Other: Online In-person peer-led faith-based intervention to encourage breast, bowel, and cervical screening uptake among Muslim women

Interventions

In-person peer-led faith-based intervention to encourage breast, bowel, and cervical screening uptake among Muslim women OTHER

The intervention includes a two-hour workshop, delivered in-person, that aims to improve the uptake of cancer screening among Muslim women. The workshop consists of four parts: * A peer-led discussion on barriers and facilitators to breast, cervical and colorectal cancer screening * A health information session led by a health professional * Videos of Muslim women talking about their experiences with cancer screening * A religious perspective on cancer screening led by a female religious scholar

In-person delivery

Online In-person peer-led faith-based intervention to encourage breast, bowel, and cervical screening uptake among Muslim women OTHER

The intervention includes a two-hour workshop, delivered online, that aims to improve the uptake of cancer screening among Muslim women. The workshop consists of four parts: * A peer-led discussion on barriers and facilitators to breast, cervical and colorectal cancer screening * A health information session led by a health professional * Videos of Muslim women talking about their experiences with cancer screening * A religious perspective on cancer screening led by a female religious scholar

Online delivery

Eligibility Criteria

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

You may qualify if:

• Women from any ethnicity identifying as Muslim
• Muslim Women aged 25-74 years
• Muslim women living in North East England or Scotland
• Muslim women who are not up-to-date with all cancer screening they are eligible for; women who are up-to-date with one type of screening but not others would be eligible (for example, women might be up-to-date with breast cancer screening but not cervical or bowel cancer screening)

You may not qualify if:

• Women who do not identify as Muslim
• Women aged less than 25 years or older than 74 years
• Women who are up-to-date with all the screening they are eligible for
• Women who had either breast, cervical or bowel cancer before as their knowledge of the disease and treatment would differ from other women who do not have any prior experience with the disease
• Women who have had BReast CAncer gene testing and underwent mastectomy and/or hysterectomy

Sponsors & Collaborators

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

Study Sites (2)

University of Glasgow

Glasgow, Scotland, United Kingdom

RECRUITING

University of Sunderland

Sunderland, Tyne and Wear, SR1 3SD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Intestinal Neoplasms; Uterine Cervical Neoplasms

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

Central Study Contacts

Floor Christie-de Jong

CONTACT

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

Rawand Jarrar

CONTACT

07940503640; rawand.jarrar@sunderland.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior lecturer

Study Record Dates

• First Submitted: August 16, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2024-05

Locations

GB (2)