Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-01 @ 4:07 PM
Study NCT ID:
NCT06469567
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Doctor's Counselling Using Culturally-responsive Pamphlet Increased Mammogram Uptake Among Malay-Muslim Women in Singapore
Sponsor:
National University Polyclinics, Singapore
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: