NCT06469567

Brief Summary

Investigators conducted a randomized controlled trial to evaluate effectiveness of doctor's counselling using a culturally-responsive pamphlet in increasing mammogram uptake among Malay-Muslim women attending the clinic. Those in intervention arm received 8-minutes doctor's counselling on mammogram and breast cancer while those in control arm received 8-minutes doctor's counselling on usual care - dietary care. Investigators recruited 319 Malay-Muslim women aged 50-69 years old who have not undergone a mammogram in the past 2 years. Investigators used Poisson regression to determine effectiveness of intervention in increasing mammogram uptake and to determine any change in knowledge, perceptions and faith-based beliefs on breast cancer and mammogram after counselling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
319

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Mar 2021

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

March 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2021

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

4 months

First QC Date

June 12, 2024

Last Update Submit

June 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants who did a mammogram after imparting intervention.

    The mammogram uptake was assessed from patient input and verified by Radiographer

    within 6 weeks of enrolment and intervention(both done on the same day

Study Arms (2)

Intervention Arm

EXPERIMENTAL

The target group received "enhanced intervention" in the form of culturally appropriate pamphlets/flipchart and doctor counselling.

Other: Patient Counselling

Control Arm

PLACEBO COMPARATOR

The control group will receive the usual standard of care without the enhanced intervention.

Other: Patient Counselling

Interventions

Doctor's counselling using Culturally-responsive pamphlet

Control ArmIntervention Arm

Eligibility Criteria

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

You may qualify if:

  • Malay-Muslim women aged 50-69 years
  • Citizens and permanent residents of Singapore without known history of breast cancer and have not undergone screening in the last two years

You may not qualify if:

  • All those except Malay-Muslim women aged 50-69 years who are citizens and permanent residents of Singapore without known history of breast cancer and have not undergone screening in the last two years.
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Polyclinics

Singapore, 609788, Singapore

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Shipra Lather

    National University Polyclinics (NUP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 21, 2024

Study Start

March 15, 2021

Primary Completion

July 16, 2021

Study Completion

July 16, 2021

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations