Breast CancerNCT06469684
A Health Education Intervention Tailored for Malay-Muslim Women
A study testing Health education session in people with Breast Cancer, run by National University of Singapore at 1 site in Singapore.
Trial summary
The goal of this experimental study is to compare mammogram rate and knowledge in healthy women of Malay ethnicity in Singapore. The main questions it aims to answer are: Will health promotion intervention in the mosque on breast cancer and mammogram lead to mammogram uptake? Will health promotion intervention in the… Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Health education session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Feb 2023to 2 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identifying as Malay-Muslim woman
- Aged 50-69
- Citizens or permanent residents of Singapore
- No history of breast cancer
- Had not gone for mammogram screening in the last 2 years
Who cannot join
- No basic fluency in the Malay language
- Not able to provide a coherent response
- Declined photography of the education session
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Culturally-responsive Health Communication Intervention for Malay-Muslim Women on Breast Cancer Screening
The goal of this experimental study is to compare mammogram rate and knowledge in healthy women of Malay ethnicity in Singapore. The main questions it aims to answer are:
- Will health promotion intervention in the mosque on breast cancer and mammogram lead to mammogram uptake?
- Will health promotion intervention in the mosque on breast cancer and mammogram lead to change in knowledge and perception related to mammogram uptake? Participants will attend an education session in the mosque on breast cancer and mammogram by religious teacher and healthcare professional and will be given an opportunity to voluntarily sign up for mammogram on the Mammobus which will be deployed to the mosque.
Researchers will compare with healthy women of Malay ethnicity attending education session in the mosque on healthy lifestyle to see if there is a difference in mammogram uptake, and in knowledge and perception towards breast cancer and mammogram.
Read the detailed description
The study will be a cluster randomized controlled trial of mosques to evaluate the impact of the education intervention. Each mosque is a cluster and intervention will be administered on a cluster level. We constructed a sampling frame of 29 large residential mosques out of the 70 mosques in Singapore. We excluded non-residential mosques and small mosques as these mosques do not conduct religious classes. From this sampling frame, we selected all 12 mosques that fulfilled the following eligibility criteria: i) a distance of at least 3.0 km from each other, to reduce bias of contamination, ii) availability of a parking space or an open area nearby for the MammoBus, and iii) high proportion of female mosque attendees as indicated by the Islamic Religious Council of Singapore (MUIS) which oversees the mosques in Singapore. We invited 12 mosques and received agreement from 6 mosques (clusters) for this trial. We stratified the mosques into 3 major housing estate regions (i.e. west, central and north), for stratified block randomization. Two mosques within each block or region were randomized by an independent researcher who is not on the study team, to the intervention arm and control arm (allocation ratio 1:1) using the ralloc package of STATA statistical software. Allocation will not be concealed. Three mosques on the intervention arm will receive the intervention package on breast cancer screening and three mosques on the control arm will receive an intervention package on healthy lifestyle. A total of 660 women will be recruited for the study by the research team on mosque grounds. All data collection is estimated to complete in 8 months.
Participants in the intervention arm will have three research visits and one optional research visit, therefore four research visits in total. Participants in the control arm will have three research visits in total. In both arms, all research visits will be conducted on mosque grounds. Mosque officers will allot time at the start or end of religious classes attended by potential participants to the research team to explain on the research study. Interested participants may approach interviewer in the mosque to sign up for the study. During recruitment, interviewer will go through the Participant Information Sheet and obtain verbal Informed Consent before conducting a baseline questionnaire. Only participants from the intervention arm will be asked for consent to be re-contacted for recruitment for a future study, a focus group discussion as the future study is not applicable for the control arm. Participant will be able to choose to attend one of the two available education sessions that will be held in the mosque over the next two weeks. Participant will be given a participant card to help them keep track of the dates of the session. The education session will be the second research visit for both arms. The third research visit is a voluntary session for those in the intervention arm, where participants may take part in a mammogram screening session in the mosque. The final research visit for both arms, fourth and third for intervention and control arm respectively, will take place between 2 months (± 1 month is applicable) from the recruitment, where a post-intervention survey will be carried out in the mosque. During this final research visit, participants that consented to be re-contacted for recruitment of a future follow-up study will be invited to participate in the follow-up study which is a focus group discussion.
Intervention package - i) Breast Cancer Screening: Participant will be required to complete a baseline questionnaire (10-15 minutes) upon recruitment and consent. Following recruitment, participant will be required to attend a group-level education session on breast cancer screening in the Malay language. This education session will last for an hour: 25 minutes education session by religious leaders on health-promoting Islamic teachings specifically on punitive religious beliefs, 10 minutes video on positive screening experience and breast cancer journey by breast cancer survivors, and 25 minutes question and answer on breast cancer by Malay-speaking health care provider. Participants will be asked to complete a short feedback form on the session. Participant will be given an educational pamphlet to reinforce health messages from the session and will be invited to attend a mammogram screening on the MammoBus. Participant may approach interviewers to sign up for the mammogram or register through the QR Code available on the participant card. This mammogram screening is voluntary and will be carried out in a MammoBus that will be deployed to the mosque in the following 2 weeks. The mammogram service is outsourced to National Healthcare Group Diagnostics (NHGD), that manages the MammoBus. The research team will only be involved in organising the mammogram appointments. Mammogram screening is a standard procedure in Singapore. In this research, mammogram screening will be according to the standard procedures and will be conducted by the trained radiographers from NHGD. Including waiting time and registration, this session should last for approximately 1 hour. Cost of mammogram screening will be borne by participants, where applicable. NHGD will inform participants of the results via mail when available. The research team and NUS as a whole will not have access to the mammogram results of the participants. At follow-up, 2 months (± 1 month is applicable) from the recruitment, participant will be required to answer a post-intervention questionnaire (10-15 minutes) which will be similar as the baseline survey, to measure changes in perception.
ii) Healthy lifestyle: Participant will be required to complete a baseline survey (10-15 minutes) upon recruitment and consent. Next, the participant will attend a group-level education session on healthy lifestyle in the Malay language. This education session will last for an hour - 30 minutes education session by religious leaders on health-promoting Islamic teachings, and 30 minutes question and answer on healthy lifestyle by Malay-speaking health care provider. Participants will be asked to complete a short feedback form on the session. At follow-up, 2 months (± 1 month is applicable) from the recruitment, participant will be required to answer a post-intervention questionnaire (10-15 minutes) which will be similar as the baseline questionnaire, to measure changes in perception.
Questionnaire and data collection - All data collected through questionnaires (pre-intervention questionnaire, feedback form and post-intervention questionnaire) will be linked via a unique code which will be given to the participant at recruitment and only this code will be used on all data. A separate encrypted file containing personal data of participants (i.e. phone number, name) linked to their unique code will be available only to the study administrator who is managing the service operations (i.e.arranging follow-up sessions and sending text reminders) of the study. A separate encrypted file containing personal data of participants that choose to go for mammogram (i.e. name, NRIC, phone number, address and date of birth) will be available only to the study administrator who is managing the mammogram appointments. Upon completion of all follow-up, recruitment for the follow-up study or completion of the mammogram appointment, whichever later, the files will be deleted therefore irreversibly de-identifying the data.
- Conditions
- Breast Cancer
- Being tested
- Health education session
- Keywords
- Mammogram, Education
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education sessionBehavioural
1 hour health education session religious teaching promoting health-seeking behaviour, and question and answer session with healthcare professional.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm receive health promotion intervention on breast cancer and mammogram including Mammobus deployment. Receives: Behavioral: Health education session |
| Control | Placebo comparator | This arm receive health promotion intervention on healthy lifestyle. Receives: Behavioral: Health education session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence Rate Ratio of Mammogram Uptake by Arm
Attending mammogram after health education session
Measured: 2-3 months
Secondary outcomes (1)
Incidence Rate Ratio of Knowledge and Perception at Follow-up by Arm, adjusting for baseline
Survey output on knowledge and perception on health behaviour, breast cancer and mammogram
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start8 Feb 2023
- Primary completion2 Sep 2023
- Study completion2 Sep 2023
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.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a matched pair cluster randomised controlled trial. Mosques in intervention and control arm are matched based on the region. Sessions within the same region (one intervention mosque and one control mosque) run parallel.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Islamic Religious Council of Singapore, National University Polyclinics, Singapore
- Responsible party
- Principal investigator, Wong Mee Lian, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469684
- Sponsor's protocol ID
- NUS-IRB-2022-662
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified survey data will be shared only upon request due to privacy and ethical concerns
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally-responsive Health Communication Intervention for Malay-Muslim Women on Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT06469684
- Acronym / sponsor ID
- NUS-IRB-2022-662
- Conditions
- Breast Cancer
- Keywords
- Mammogram, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Islamic Religious Council of Singapore, National University Polyclinics, Singapore
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 2 Sep 2023 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 24 Jun 2024 (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 experimental study is to compare mammogram rate and knowledge in healthy women of Malay ethnicity in Singapore. The main questions it aims to answer are:
- Will health promotion intervention in the mosque on breast cancer and mammogram lead to mammogram uptake?
- Will health promotion intervention in the mosque on breast cancer and mammogram lead to change in knowledge and perception related to mammogram uptake? Participants will attend an education session in the mosque on breast cancer and mammogram by religious teacher and healthcare professional and will be given an opportunity to voluntarily sign up for mammogram on the Mammobus which will be deployed to the mosque.
Researchers will compare with healthy women of Malay ethnicity attending education session in the mosque on healthy lifestyle to see if there is a difference in mammogram uptake, and in knowledge and perception towards breast cancer and mammogram.
Detailed description
The study will be a cluster randomized controlled trial of mosques to evaluate the impact of the education intervention. Each mosque is a cluster and intervention will be administered on a cluster level. We constructed a sampling frame of 29 large residential mosques out of the 70 mosques in Singapore. We excluded non-residential mosques and small mosques as these mosques do not conduct religious classes. From this sampling frame, we selected all 12 mosques that fulfilled the following eligibility criteria: i) a distance of at least 3.0 km from each other, to reduce bias of contamination, ii) availability of a parking space or an open area nearby for the MammoBus, and iii) high proportion of female mosque attendees as indicated by the Islamic Religious Council of Singapore (MUIS) which oversees the mosques in Singapore. We invited 12 mosques and received agreement from 6 mosques (clusters) for this trial. We stratified the mosques into 3 major housing estate regions (i.e. west, central and north), for stratified block randomization. Two mosques within each block or region were randomized by an independent researcher who is not on the study team, to the intervention arm and control arm (allocation ratio 1:1) using the ralloc package of STATA statistical software. Allocation will not be concealed. Three mosques on the intervention arm will receive the intervention package on breast cancer screening and three mosques on the control arm will receive an intervention package on healthy lifestyle. A total of 660 women will be recruited for the study by the research team on mosque grounds. All data collection is estimated to complete in 8 months.
Participants in the intervention arm will have three research visits and one optional research visit, therefore four research visits in total. Participants in the control arm will have three research visits in total. In both arms, all research visits will be conducted on mosque grounds. Mosque officers will allot time at the start or end of religious classes attended by potential participants to the research team to explain on the research study. Interested participants may approach interviewer in the mosque to sign up for the study. During recruitment, interviewer will go through the Participant Information Sheet and obtain verbal Informed Consent before conducting a baseline questionnaire. Only participants from the intervention arm will be asked for consent to be re-contacted for recruitment for a future study, a focus group discussion as the future study is not applicable for the control arm. Participant will be able to choose to attend one of the two available education sessions that will be held in the mosque over the next two weeks. Participant will be given a participant card to help them keep track of the dates of the session. The education session will be the second research visit for both arms. The third research visit is a voluntary session for those in the intervention arm, where participants may take part in a mammogram screening session in the mosque. The final research visit for both arms, fourth and third for intervention and control arm respectively, will take place between 2 months (± 1 month is applicable) from the recruitment, where a post-intervention survey will be carried out in the mosque. During this final research visit, participants that consented to be re-contacted for recruitment of a future follow-up study will be invited to participate in the follow-up study which is a focus group discussion.
Intervention package - i) Breast Cancer Screening: Participant will be required to complete a baseline questionnaire (10-15 minutes) upon recruitment and consent. Following recruitment, participant will be required to attend a group-level education session on breast cancer screening in the Malay language. This education session will last for an hour: 25 minutes education session by religious leaders on health-promoting Islamic teachings specifically on punitive religious beliefs, 10 minutes video on positive screening experience and breast cancer journey by breast cancer survivors, and 25 minutes question and answer on breast cancer by Malay-speaking health care provider. Participants will be asked to complete a short feedback form on the session. Participant will be given an educational pamphlet to reinforce health messages from the session and will be invited to attend a mammogram screening on the MammoBus. Participant may approach interviewers to sign up for the mammogram or register through the QR Code available on the participant card. This mammogram screening is voluntary and will be carried out in a MammoBus that will be deployed to the mosque in the following 2 weeks. The mammogram service is outsourced to National Healthcare Group Diagnostics (NHGD), that manages the MammoBus. The research team will only be involved in organising the mammogram appointments. Mammogram screening is a standard procedure in Singapore. In this research, mammogram screening will be according to the standard procedures and will be conducted by the trained radiographers from NHGD. Including waiting time and registration, this session should last for approximately 1 hour. Cost of mammogram screening will be borne by participants, where applicable. NHGD will inform participants of the results via mail when available. The research team and NUS as a whole will not have access to the mammogram results of the participants. At follow-up, 2 months (± 1 month is applicable) from the recruitment, participant will be required to answer a post-intervention questionnaire (10-15 minutes) which will be similar as the baseline survey, to measure changes in perception.
ii) Healthy lifestyle: Participant will be required to complete a baseline survey (10-15 minutes) upon recruitment and consent. Next, the participant will attend a group-level education session on healthy lifestyle in the Malay language. This education session will last for an hour - 30 minutes education session by religious leaders on health-promoting Islamic teachings, and 30 minutes question and answer on healthy lifestyle by Malay-speaking health care provider. Participants will be asked to complete a short feedback form on the session. At follow-up, 2 months (± 1 month is applicable) from the recruitment, participant will be required to answer a post-intervention questionnaire (10-15 minutes) which will be similar as the baseline questionnaire, to measure changes in perception.
Questionnaire and data collection - All data collected through questionnaires (pre-intervention questionnaire, feedback form and post-intervention questionnaire) will be linked via a unique code which will be given to the participant at recruitment and only this code will be used on all data. A separate encrypted file containing personal data of participants (i.e. phone number, name) linked to their unique code will be available only to the study administrator who is managing the service operations (i.e.arranging follow-up sessions and sending text reminders) of the study. A separate encrypted file containing personal data of participants that choose to go for mammogram (i.e. name, NRIC, phone number, address and date of birth) will be available only to the study administrator who is managing the mammogram appointments. Upon completion of all follow-up, recruitment for the follow-up study or completion of the mammogram appointment, whichever later, the files will be deleted therefore irreversibly de-identifying the data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a matched pair cluster randomised controlled trial. Mosques in intervention and control arm are matched based on the region. Sessions within the same region (one intervention mosque and one control mosque) run parallel.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Health education sessionThis arm receive health promotion intervention on breast cancer and mammogram including Mammobus deployment. |
| Control | Placebo comparator | Behavioral: Health education sessionThis arm receive health promotion intervention on healthy lifestyle. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Identifying as Malay-Muslim woman
- Aged 50-69
- Citizens or permanent residents of Singapore
- No history of breast cancer
- Had not gone for mammogram screening in the last 2 years
Key exclusion criteria (3 listed)
- No basic fluency in the Malay language
- Not able to provide a coherent response
- Declined photography of the education session
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 |
|---|---|---|
| Health education session1 hour health education session religious teaching promoting health-seeking behaviour, and question and answer session with healthcare professional. | Behavioural | Control, Intervention |
Primary outcome
Incidence Rate Ratio of Mammogram Uptake by Arm
Time frame: 2-3 months
Attending mammogram after health education session
1 secondary outcome
Incidence Rate Ratio of Knowledge and Perception at Follow-up by Arm, adjusting for baseline
Time frame: 2-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Individual participant dataSharing planned: No. De-identified survey data will be shared only upon request due to privacy and ethical concerns
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health education session in people with Breast Cancer, run by National University of Singapore at 1 site in Singapore.
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 3 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: finished, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence Rate Ratio of Mammogram Uptake by Arm (time frame: 2-3 months). 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 24 Jun 2024.