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

Breast Cancer Clinical Trial

— IMCAN  

Official title:

Improving Uptake of Breast, Bowel and Cervical Cancer Screening Among Muslim Women: a Non-randomised Feasibility Study of a Peer-led, Faith-based Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06106165
• Other study ID #: EDDPJT-May22\100030
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: University of Sunderland
• Contact: Floor Christie-de Jong
• Phone: 0191 5153445
• Email: floor.christie[@]sunderland.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Low rates of cancer screening among Muslim women puts them at higher risk of death from screening since they do not detect cancer early. This study will work to increase the uptake of cancer screening among Muslim women using two-hour workshops delivered in the community. The workshops were developed with the help of 10 Muslim women in Scotland. The workshops include four parts: - A discussion on the barriers and facilitators to breast, cervical and colorectal cancer screening - A health information session given by a female health provider on cancer screening - Videos of Muslim women talking about their experiences with cancer screening - A session given by a female religious scholar to discuss Islamic perspectives on cancer screening. Another eighteen Muslim women then took part in the workshops; they gave positive feedback on the content of the workshops and how the sessions were delivered. In the feasibility trial, the workshops will be delivered to 200 Muslim women to find out whether a full-scale randomised-controlled trial can take place. This study will be carried out with the help of 10 Muslim women who will give advice on the content of the workshops and plan for implementation; they will also help with the delivery of the workshops. It is expected that this study will lead to changes in knowledge and screening uptake among participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 74 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Bowel Cancer
• Breast Cancer
• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	University of Glasgow	Glasgow	Scotland
United Kingdom	University of Sunderland	Sunderland	Tyne And Wear

Sponsors (2)

Lead Sponsor	Collaborator
University of Sunderland	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Questionnaire response rate	The proportion of participants responding to questionnaires at baseline, 6 months and 12 months.	Baseline, 6 months, 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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 Higher scores indicate higher levels of religious fatalism, thus a lower willingness to attend screening due to religious beliefs	Baseline
Secondary	Modesty	The Modesty Measure for Muslim women (MMM-W) will be given to participants to examine how self-representation among Muslim women can affect their health seeking behaviours.; The questionnaire will ask participants to indicate whether they 'agree', 'disagree' or 'ambivalent' to 10 statements about modest behaviour and healthcare	Baseline
Secondary	Sociodemographic descriptors	Participant characteristics, such as age, location, education level, ethnicity, professional occupation and marital status, will be recorded	Baseline
Secondary	Cancer knowledge questions adapted from Cancer Awareness Measures (CAM) by Cancer Research UK	This measure will assess changes in knowledge about the risk factors, symptoms and screening of breast, bowel and cervical cancer among participants.; The questionnaire will be administered online through Qualtrics (a telephone option will also be offered).; Multiple choice questions are used for this measure.	baseline, 6 months and 12 months
Secondary	Cancer screening behaviour	A cancer screening behaviour questionnaire will be given to participants. This consists of 2 parts: Participants will be asked about whether they attended breast, bowel or cervical cancer screening and if they are planning to attend screening. The answers for these questions will be: 'yes', 'no' or 'I don't know'.; The second part includes statements that represent barrier and facilitator beliefs that might affect screening behaviour. Participants will be asked to indicate the level of agreement with each statement on 5-point liker scale: 1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree	baseline, 6 months and 12 months
Secondary	Self-reported screening uptake	Change in the number of participants who obtained screening following the intervention. This outcome is self-reported by participants	baseline, 6 months and 12 months
Secondary	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.	baseline, 6 months and 12 months
Secondary	Quality of life measures	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: no problems, slight problems, moderate problems, severe problems and extreme problems.	Baseline, 6 months, 12 months