- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06469567
Doctor's Counselling Using Culturally-responsive Pamphlet Increased Mammogram Uptake Among Malay-Muslim Women in Singapore
Doctor's Counselling Using Culturally-responsive Pamphlet Increased Mammogram Uptake Among Malay-Muslim Women in Singapore: A Randomized Controlled Trial in a Primary Healthcare Clinic
Study Overview
Detailed Description
A randomized control trial was conducted at Jurong Polyclinic with the intervention arm receiving the enhanced culturally appropriate intervention, and the control arm, the usual standard of care for mammography.
Inclusion criteria 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 will be eligible for the study. These participants were recruited from Jurong Polyclinic when they came for their chronic or acute care needs.
A written informed consent was taken.
Intervention:
The target group received "enhanced intervention" in the form of culturally appropriate pamphlets/flipchart (Annex 1) and doctor counselling. After the counselling, all the women in the intervention group were referred to the staff-in-charge for a mammogram appointment in the polyclinic where they will be able to make an appointment voluntarily. All appointments were given within a period of 3 to 4 weeks. They were also given a pamphlet on breast cancer and mammogram as reinforcement after the counselling.
The control group received the usual standard of care without the "enhanced intervention".
However, they received a "placebo-attention" based on the "Healthy eating guide". Patients in this group took their own initiative to make an appointment for a mammogram.
The counselling to both groups was of a similar duration to control for Hawthorne effect.
Data collection:
Enrolment of eligible participants was by successive presentation at the polyclinic. Single blinding of the participants was done.
Anonymity was maintained by issuing unique identification numbers to all subjects.
Data was collected at baseline and 6 to 8 weeks after intervention. This interval duration is due to limitation of the time frame of the study for the practicum.
The participants filled out a self-administered questionnaire available in Malay, at baseline, to assess their knowledge, attitude, misinformation and perceptions about mammogram. Assistance was given when there was any lack of understanding.
Both the intervention and control groups were advised to come to the polyclinic for follow-up at 6 to 8 weeks. The same self-administered questionnaire on their knowledge, attitude, misinformation and perceptions about mammogram and breast cancer was given to the participants for completion. They were also asked on whether they have gone for a mammogram in the last 6-8 weeks post-intervention. This self-reported mammogram was validated with the medicals records of having had a mammogram.
When the post intervention follow-up at the polyclinic is not possible, an outreach via phone call was done to collect data.
Steps were taken to minimize social desirability bias.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 609788
- National University Polyclinics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm
The target group received "enhanced intervention" in the form of culturally appropriate pamphlets/flipchart and doctor counselling.
|
Doctor's counselling using Culturally-responsive pamphlet
|
|
Placebo Comparator: Control Arm
The control group will receive the usual standard of care without the enhanced intervention.
|
Doctor's counselling using Culturally-responsive pamphlet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who did a mammogram after imparting intervention.
Time Frame: within 6 weeks of enrolment and intervention(both done on the same day
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shipra Lather, National University Polyclinics (NUP)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020/01244
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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