NCT06469684

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

June 13, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

Mammogram, Education

Outcome Measures

Primary Outcomes (1)

  • Incidence Rate Ratio of Mammogram Uptake by Arm

    Attending mammogram after health education session

    2-3 months

Secondary Outcomes (1)

  • Incidence Rate Ratio of Knowledge and Perception at Follow-up by Arm, adjusting for baseline

    2-3 months

Study Arms (2)

Intervention

EXPERIMENTAL

This arm receive health promotion intervention on breast cancer and mammogram including Mammobus deployment.

Behavioral: Health education session

Control

PLACEBO COMPARATOR

This arm receive health promotion intervention on healthy lifestyle.

Behavioral: Health education session

Interventions

1 hour health education session religious teaching promoting health-seeking behaviour, and question and answer session with healthcare professional.

ControlIntervention

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No basic fluency in the Malay language
  • Not able to provide a coherent response
  • Declined photography of the education session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University of Singapore

Singapore, 117549, Singapore

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Randomisation done at mosque level. Allocation was not masked from individuals recruiting and delivering the interventions in the mosque. All participants within the same mosque receive the same intervention. Thus participants are only notified of the session conducted in the mosque they were recruited in.All participants are masked from the sessions conducted in other mosques.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2024

First Posted

June 24, 2024

Study Start

February 8, 2023

Primary Completion

September 2, 2023

Study Completion

September 2, 2023

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

De-identified survey data will be shared only upon request due to privacy and ethical concerns

Locations