[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658430":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":42,"studyPopulation":39,"armGroups":43,"interventions":79,"overallOfficials":100,"centralContacts":104,"locations":113,"responsibleParty":163,"collaborators":165,"id":171,"slug":172,"hasResults":173,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":39,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":179,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":39,"studyType":185,"phases":186,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":196,"whyStopped":39,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"National Cancer Centre, Singapore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"FIT completion.","By the end of 3 months, FIT completion rates will be analyzed as either completed or not completed.","3 months.",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Follow-up Colonoscopy completion after positive FIT screening.","By the end of 6 months after positive FIT, follow-up Colonoscopy rates will be analyzed as either completed or not completed.","6 months after positive FIT screening.",{"measure":19,"description":20,"timeFrame":21},"Diagnosis of CRC.","Diagnosis of CRC will be ascertained by histology obtained from colonoscopy. Diagnosis of CRC will be analyzed as either positive for CRC or normal.","6 months.",{"measure":23,"description":24,"timeFrame":21},"Stage of CRC at diagnosis.","Our study will collect the stage of CRC at diagnosis. Staging will be determined by the AJCC 8th Edition TNM Staging System for CRC.",{"measure":26,"description":27,"timeFrame":28},"Cancer-specific mortality.","Our study will collect data on cancer-specific mortality till end of study duration. Patients with cancer-related causes of mortality will be analyzed as cancer-specific mortality.","4 years.",[30],{"measure":31,"description":32,"timeFrame":33},"Cost-effectiveness of the screening programme.","Combination of costs incurred from intervention delivery, implementation, navigation, and downstream healthcare costs. Cost-effectiveness analysis will be conducted using a Markov modelling approach, with health states corresponding to different stages of disease including disease-free, different stages of CRC, remission, and death.","4 years post-randomization.",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":39,"timePerspective":39,"maskingInfo":40},"RANDOMIZED","PARALLEL","Our seven-arm RCT will compare the effectiveness of different multi-modal interventions. Randomization will be conducted at the individual participant level in quarterly cohorts rather than through a continuous sequential process. A total of 40,000 eligible participants will be enrolled, with approximately 10,000 participants included in each quarterly cohort. Prior to study initiation, the study statisticians will prepare a computer-generated stratified block randomization schedule, stratified by polyclinic site and quarterly cohort, to ensure balanced allocation across sites and enrolment periods.\n\nAfter the participant list for a given quarter has been finalized and locked, all participants within that cohort will be randomized simultaneously according to the pre-generated randomization schedule. Participants will be allocated in a 2:1:1:1:1:1:1 ratio between the control arm (Usual Care) and each of the six intervention arms.","HEALTH_SERVICES_RESEARCH",null,{"masking":41,"maskingDescription":39,"whoMasked":39},"NONE","CRC is the second most common cancer and cause of cancer-related mortality in Singapore. However, completion of CRC screenings remains suboptimal, with only 44.9% of eligible adults aged 50-74 years in Singapore up to date with CRC screening, far below the recommended 80% CRC screening completion rate set by the US Multi-Society Task Force on CRC. Singapore currently adopts a risk-stratified model for CRC screening, in which asymptomatic individuals without a family history of CRC are regarded as average-risk and are recommended annual fecal immunochemical test (FIT) or 5 to 10 yearly colonoscopies from 50 years old. However, these are usually recommended opportunistically by primary care providers during a routine healthcare visit. Among average-risk individuals, patients are more likely to participate in stool-based testing (34%-39%) than colonoscopy (24%-31%).\n\nWhile FIT screening is cost-effective for health systems while reducing CRC mortality, the substantial screening gap underscores the need for interventions to increase FIT uptake. Numerous studies in other settings have compared the effectiveness of interventions such as mailed FIT, patient reminders, and patient navigation in improving screening uptake. Among these, mailed FIT outreach has emerged as a particularly effective strategy, reducing logistical barriers and enabling wider population coverage. Gupta et al. found that CRC screening participation was significantly higher for patients with mailed FIT (40.7%) compared to usual care (12.1%). A meta-analysis of randomized controlled trials (RCTs) by Ramal et al. found that patient navigation (RR, 1.58; 95% CI, 1.23-2.02) outperformed usual care in increasing CRC screening uptake. Meanwhile, a recent trial by Korostoff-Larsson et al. found that SMS reminders were associated with significantly improved FIT completion compared with usual telephone call reminders (58.9% vs 49.8%). The TEMPO trial by Robb et al. found that setting a 2-week deadline increased the FIT return rate compared with control (68.0% vs 63.2%). However, most of these studies compared single outreach interventions against usual care alone, leaving limited evidence on cost-effectiveness and on whether combining interventions produces synergistic, additive, or antagonistic effects. Therefore, it is important to assess the most effective and efficient strategy in the local context.\n\nA successful FIT programme requires adherence to follow-up colonoscopy after an abnormal result. Large studies using data from community or national screening programs have shown colonoscopy completion rates of only 32%-56% within 1 year of an abnormal FIT\u002FFOBT, and non-adherence to follow-up colonoscopy is associated with higher CRC incidence and mortality. A meta-analysis of 21 studies by our study team identified four interventions that increased completion of follow-up colonoscopy after an abnormal FIT: patient navigation (RR 1.24), patient reminders (RR 1.32), provider reminders (RR 1.36), and automated referral to gastrointestinal (GI) consult (RR 1.68).\n\nTherefore, this study aims to identify the most effective and cost-effective strategy for increasing CRC screening participation and adherence within Singapore's public healthcare system. Specific objectives are to:\n\n1. evaluate the effectiveness of mailed FIT outreach, reminders, patient navigation, and behavioural interventions in increasing initial FIT completion, sustained annual FIT adherence across three screening rounds, and reducing screening disparities;\n2. assess the effectiveness of an evidence-based programme incorporating patient reminders, patient navigation, provider reminders, and automated gastroenterology referrals in increasing follow-up colonoscopy completion after abnormal FIT results;\n3. evaluate whether improved screening participation and diagnostic follow-up increase the detection of early-stage CRC; and\n4. evaluate the cost-effectiveness of competing intervention strategies from the healthcare system perspective.\n\nThis is a 3-year longitudinal screening trial consisting of 3 annual rounds of screening. Participants enrolled in Round 1 (Year 1) are intended to be followed for subsequent annual screenings (Year 2 and Year 3). Research funding and institutional approval are secured for Round 1; Rounds 2 and 3 are pending final funding approval.",[44,48,54,59,64,69,74],{"label":45,"type":46,"description":47,"interventionNames":39},"Arm A: Usual Care","NO_INTERVENTION","CRC screenings are recommended opportunistically by primary care providers during routine healthcare visits.",{"label":49,"type":50,"description":51,"interventionNames":52},"Arm B: SMS Reminders","ACTIVE_COMPARATOR","Three SMS reminders spaced one week apart will be sent to the patient on top of usual care.",[53],"Behavioral: SMS Reminders",{"label":55,"type":50,"description":56,"interventionNames":57},"Arm C: SMS Reminders + Mailed Reminder","Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. A mailed reminder will be sent to participants by the 4th week from Day 0.",[58],"Behavioral: SMS reminders + mailed reminder",{"label":60,"type":50,"description":61,"interventionNames":62},"Arm D: SMS Reminders + Mailed Reminder + Patient Navigation","Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. A mailed reminder will be sent to participants by the 4th week from Day 0. Patient navigation\u002FFollow-up phone call by staff if the FIT kit is not returned by the end of 6th week from Day 0.",[63],"Behavioral: SMS reminders + mailed reminder + patient navigation",{"label":65,"type":50,"description":66,"interventionNames":67},"Arm E: SMS Reminders + Mailed Return","Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. Participants will be given an option to return the clinic-distributed FIT kits via mail.",[68],"Behavioral: SMS reminders + mailed return",{"label":70,"type":50,"description":71,"interventionNames":72},"Arm F: SMS Reminders + Mailed FIT","A FIT kit will be mailed to the participant's address at the start of the study, accompanied by outreach materials. Three SMS reminders spaced one week apart will be sent to the patient on top of usual care.",[73],"Behavioral: SMS reminders + mailed FIT",{"label":75,"type":50,"description":76,"interventionNames":77},"Arm G: SMS Reminders + Mailed FIT + Patient Navigation","A FIT kit will be mailed to the participant's address at the start of the study, accompanied by outreach materials. Three SMS reminders spaced one week apart will be sent to the patient on top of usual care. Patient navigation\u002FFollow-up phone call by staff if the FIT kit is not returned by the end of 6th week from Day 0.",[78],"Behavioral: SMS reminders + mailed FIT + patient navigation",[80,85,88,91,94,97],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":39},"BEHAVIORAL","SMS Reminders","5,000 patients will be allocated in this arm.",[49],{"type":81,"name":86,"description":83,"armGroupLabels":87,"otherNames":39},"SMS reminders + mailed reminder",[55],{"type":81,"name":89,"description":83,"armGroupLabels":90,"otherNames":39},"SMS reminders + mailed reminder + patient navigation",[60],{"type":81,"name":92,"description":83,"armGroupLabels":93,"otherNames":39},"SMS reminders + mailed return",[65],{"type":81,"name":95,"description":83,"armGroupLabels":96,"otherNames":39},"SMS reminders + mailed FIT",[70],{"type":81,"name":98,"description":83,"armGroupLabels":99,"otherNames":39},"SMS reminders + mailed FIT + patient navigation",[75],[101],{"name":102,"affiliation":5,"role":103},"Dr Kennedy NG","PRINCIPAL_INVESTIGATOR",[105,110],{"name":106,"role":107,"phone":108,"phoneExt":39,"email":109},"Ms LEE Kit Yee","CONTACT","+65 6346 8000","lee.kit.yee@singhealth.com.sg",{"name":111,"role":107,"phone":39,"phoneExt":39,"email":112},"Dr CHUA Wei Yu","chua.wei.yu@mohh.com.sg",[114,128,137,146,155],{"facility":115,"status":39,"city":116,"state":39,"zip":117,"country":116,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"SingHealth Polyclinic","Singapore","150167","SG",{"type":120,"coordinates":121},"Point",[122,123],103.85007,1.28967,{"lat":123,"lon":122},[126],{"name":127,"role":107,"phone":39,"phoneExt":39,"email":39},"Dr KOH Kim Hwee, MBBS",{"facility":129,"status":39,"city":116,"state":39,"zip":130,"country":116,"countryCode":118,"cosmosGeoPoint":131,"geoPoint":133,"contacts":134},"National Cancer Center, Singapore","168583",{"type":120,"coordinates":132},[122,123],{"lat":123,"lon":122},[135],{"name":136,"role":107,"phone":39,"phoneExt":39,"email":39},"Dr Kennedy NG, MBBS (Hons), MRCP, MPA",{"facility":138,"status":39,"city":116,"state":39,"zip":139,"country":116,"countryCode":118,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"Changi General Hospital","529889",{"type":120,"coordinates":141},[122,123],{"lat":123,"lon":122},[144],{"name":145,"role":107,"phone":39,"phoneExt":39,"email":39},"A\u002FProf Andrew KWEK Boon Eu, MBBS, MRCP",{"facility":147,"status":39,"city":116,"state":39,"zip":148,"country":116,"countryCode":118,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"Sengkang General Hospital","544886",{"type":120,"coordinates":150},[122,123],{"lat":123,"lon":122},[153],{"name":154,"role":107,"phone":39,"phoneExt":39,"email":39},"Dr Clarence KWAN Kah Wai, MBBS, MRCP",{"facility":156,"status":39,"city":116,"state":39,"zip":39,"country":116,"countryCode":118,"cosmosGeoPoint":157,"geoPoint":159,"contacts":160},"Singapore General Hospital",{"type":120,"coordinates":158},[122,123],{"lat":123,"lon":122},[161],{"name":162,"role":107,"phone":39,"phoneExt":39,"email":39},"Prof Emile John TAN Kwong Wei, MBBS, FRCS",{"type":164,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[166,167,168,169],{"name":147,"class":6},{"name":138,"class":6},{"name":156,"class":6},{"name":115,"class":170},"UNKNOWN","100658430","mailed-fit-based-outreach-interventions-100658430",false,"NCT07852793","Mailed FIT-Based Outreach Interventions","Mailed FIT-Based Outreach Interventions vs Usual Care to Increase Uptake of Colorectal Cancer Screening in a Multi-Ethnic Population: A 7-Arm Randomized Controlled Trial","Inclusion Criteria:\n\n* Eligible individuals are those enrolled with SingHealth Polyclinics aged 50-80 at time of study initiation, who are due for CRC screening (i.e., no FIT within the past year, or no colonoscopy within the past 5-10 years)\n\nExclusion Criteria:\n\n* Prior diagnosis of CRC, advanced cancer, or palliative care",true,"ALL","50 Years","80 Years",{"count":183,"type":184},40000,"ESTIMATED","INTERVENTIONAL",[187],"NA","Colorectal cancer (CRC) is the second most common cancer and the second leading cause of cancer-related mortality in Singapore. Although annual fecal immunochemical testing (FIT) and periodic colonoscopy are recommended for average-risk adults aged 50-75, only 44.9% of eligible individuals are up to date with CRC screening. Screening participation, adherence to repeat annual FIT, and completion of diagnostic colonoscopy after abnormal FIT results remain suboptimal. This study aims to identify the most effective and cost-effective strategy for increasing CRC screening participation and adherence.",[190],"Colorectal Cancer",[190,192,193,194,195],"Cancer Screening","FIT","Interventions","Follow-up Colonoscopy","NOT_YET_RECRUITING","2026-09-28",{"date":199,"type":200},"2026-10-01","ACTUAL",{"date":202,"type":184},"2026-10-30",{"date":204,"type":184},"2030-10-30",{"name":5,"class":6},5]