Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-03-05 @ 12:30 AM
Study NCT ID:
NCT06469567
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-06-12
Is 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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-17', 'studyFirstSubmitDate': '2024-06-12', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants who did a mammogram after imparting intervention.', 'timeFrame': 'within 6 weeks of enrolment and intervention(both done on the same day', 'description': 'The mammogram uptake was assessed from patient input and verified by Radiographer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nInclusion 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.\n\nA written informed consent was taken.\n\nIntervention:\n\nThe 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.\n\nThe control group received the usual standard of care without the "enhanced intervention".\n\nHowever, 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.\n\nThe counselling to both groups was of a similar duration to control for Hawthorne effect.\n\nData collection:\n\nEnrolment of eligible participants was by successive presentation at the polyclinic. Single blinding of the participants was done.\n\nAnonymity was maintained by issuing unique identification numbers to all subjects.\n\nData 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.\n\nThe 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.\n\nBoth 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.\n\nWhen the post intervention follow-up at the polyclinic is not possible, an outreach via phone call was done to collect data.\n\nSteps were taken to minimize social desirability bias.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '50 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Malay-Muslim women aged 50-69 years\n* Citizens and permanent residents of Singapore without known history of breast cancer and have not undergone screening in the last two years\n\nExclusion Criteria:\n\n* 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.\n* Pregnant women'}, 'identificationModule': {'nctId': 'NCT06469567', 'briefTitle': "Doctor's Counselling Using Culturally-responsive Pamphlet Increased Mammogram Uptake Among Malay-Muslim Women in Singapore", 'organization': {'class': 'OTHER', 'fullName': 'National University Polyclinics, Singapore'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '2020/01244'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'The target group received "enhanced intervention" in the form of culturally appropriate pamphlets/flipchart and doctor counselling.', 'interventionNames': ['Other: Patient Counselling']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Arm', 'description': 'The control group will receive the usual standard of care without the enhanced intervention.', 'interventionNames': ['Other: Patient Counselling']}], 'interventions': [{'name': 'Patient Counselling', 'type': 'OTHER', 'description': "Doctor's counselling using Culturally-responsive pamphlet", 'armGroupLabels': ['Control Arm', 'Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '609788', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Polyclinics', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Shipra Lather', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Polyclinics (NUP)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Polyclinics, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}