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Breast CancerNCT06469567

Doctor's Counselling Using Culturally-responsive Pamphlet Increased Mammogram Uptake Among Malay-Muslim Women in Singapore

A study testing Patient Counselling in people with Breast Cancer, run by National University Polyclinics, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. 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?
Patient Counselling
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
319 participants
Where
1 siteSingapore
Study dates
15 Mar 2021to 16 Jul 2021
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site
  • National University Polyclinics

    Singapore, 609788

Other trials in Singapore

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Patient Counselling
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient CounsellingOther

    Doctor's counselling using Culturally-responsive pamphlet

Study groups in NCT06469567
Study groupRoleWhat they receive
Intervention ArmExperimentalThe target group received "enhanced intervention" in the form of culturally appropriate pamphlets/flipchart and doctor counselling.
Receives: Other: Patient Counselling
Control ArmPlacebo comparatorThe control group will receive the usual standard of care without the enhanced intervention.
Receives: Other: Patient Counselling

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2024
  2. Study start15 Mar 2021
  3. Primary completion16 Jul 2021
  4. Study completion16 Jul 2021

Resources

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
Masking
Single blind
Who is masked
Participant
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06469567
Sponsor's protocol ID
2020/01244
Status last verified
Jun 2024
First submitted
12 Jun 2024
Last updated
21 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Patient Counselling in people with Breast Cancer, run by National University Polyclinics, 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 2 inclusion and 2 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 21 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?

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). 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 21 Jun 2024.

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