[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653157":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":15,"studyPopulation":15,"armGroups":32,"interventions":55,"overallOfficials":73,"centralContacts":77,"locations":86,"responsibleParty":105,"collaborators":15,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":15,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":15,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":131,"overallStatus":136,"whyStopped":15,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":15},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Change in CRC knowledge (Education Arm only)","Change in CRC knowledge will be measured by changes in the score of the Assessment of Colon Cancer Literacy (ACCL) test. The ACCL consists of 10-items with True\u002FFalse\u002FUnsure. The ACCL score ranges from 0 to 10 with a score of 7-10 indicating adequate literacy and scores of 0-6 indicating limited literacy.","At enrollment and 3 months after educational intervention (total estimated time is 3 months)",{"measure":14,"description":15,"timeFrame":16},"Feasibility as measured by the percentage of kits returned (Mailed FIT and Mailed Cologuard Arms only)",null,"At 3 months after receiving kit (total estimated time 3 months)",{"measure":18,"description":19,"timeFrame":20},"Acceptability of stool based testing (Mailed FIT and Mailed Cologuard Arms only)","Acceptability will be assessed using the 3-item Customer Service Questionnaire (CSQ-3). The 3-items are rated on a 4-point Likert scale as follows: 1=Poor, 2=Fair, 3=Good, and 4=Excellent. Generally, the higher the score indicates greater customer satisfaction.","At completion of testing or at 3 months after receiving test kit (total estimated time 3 months)",{"measure":22,"description":23,"timeFrame":24},"CRC screening completion rate (All arms)","CRC screening completion rate will be assessed through electronic health record (EHR) verification of screening completion.","From time of receiving CRC kit to 6 months after receiving kit (total estimated time 6 months)",{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":15,"timePerspective":15,"maskingInfo":30},"RANDOMIZED","PARALLEL","All patients are assigned to a resident primary care provider. Each resident is assigned to a team-based structure within the resident clinic, and there are 12 resident teams. Each team is composed of 12 residents, and each resident has a patient panel of \\~100 patients. Participants will be recruited via resident patient panels and randomized 1:1:1 by resident clinic teams.\n\nThe Education Arm will be drawn from patients who agreed to be recontacted from a prior study and will not be randomized.","SCREENING",{"masking":31,"maskingDescription":15,"whoMasked":15},"NONE",[33,39,44,49],{"label":34,"type":35,"description":36,"interventionNames":37},"Education","EXPERIMENTAL","Participants will complete the Assessment of Colon Cancer Literacy (ACCL) as a pre-test prior to receiving education materials. After the pre-test, participants will be provided with ACCL education materials. Three months after being provided education materials, participants will repeat ACCL testing.",[38],"Behavioral: Colorectal Cancer Education Materials",{"label":40,"type":35,"description":41,"interventionNames":42},"Mailed FIT","Participants will receive a mailed package including 1 FIT test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart.\n\nParticipants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient.",[43],"Diagnostic Test: Fecal immunochemical test kit",{"label":45,"type":35,"description":46,"interventionNames":47},"Mailed Cologuard","Participants will receive a mailed package including 1 Cologuard test, step-by-step written and pictorial instructions, a prepaid, trackable return envelope, a brief explanation of how the testing works and how results will be communicated, and education materials about CRC. Participants will have 3 months to return the kit. Participants who return kits will complete the Client Satisfaction Questionnaire (CSQ-3) by phone or via MyChart.\n\nParticipants will be contacted three times by phone as reminders to complete the kit. After three reminders, the team will stop attempting to contact the patient.",[48],"Diagnostic Test: Cologuard test kit",{"label":50,"type":51,"description":52,"interventionNames":53},"Usual Care","ACTIVE_COMPARATOR","Participants will receive usual care from provider after enrollment with no intervention. Usual care includes providers offering standard screening options including FIT, Cologuard, and colonoscopy at the initial visit with no default option or structured follow-up.",[54],"Behavioral: Usual Care",[56,61,66,70],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":15},"BEHAVIORAL","Colorectal Cancer Education Materials","Education materials are compiled from the American College of Gastroenterology (ACG) and the City of Hope. The education materials are at a 6th grade reading level. Materials detail digestive system and polyp background, colorectal cancer (CRC) risk factors, warning signs, screening options, recommended initial screening age, and stool-based screening and colonoscopy processes.",[34],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":15},"DIAGNOSTIC_TEST","Cologuard test kit","The Cologuard test will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.",[45],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":15},"Fecal immunochemical test kit","The Fecal immunochemical test (FIT) will be mailed to the participants. Participants will complete the test via the step-by-step written and pictorial instructions provided and mail the complete test with the pre-paid return label provided.",[40],{"type":57,"name":50,"description":71,"armGroupLabels":72,"otherNames":15},"Usual care for patients eligible for colorectal cancer screening will be provided by the Barnes-Jewish Hospital Primary Care Medicine Clinic.",[50],[74],{"name":75,"affiliation":5,"role":76},"Cassandra Fritz, MD, MPHS","PRINCIPAL_INVESTIGATOR",[78,82],{"name":75,"role":79,"phone":80,"phoneExt":15,"email":81},"CONTACT","314-454-8165","cfritz@wustl.edu",{"name":83,"role":79,"phone":84,"phoneExt":15,"email":85},"Darren Nix","314-362-3201","nixd@wustl.edu",[87],{"facility":5,"status":15,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"St Louis","Missouri","63110","United States","US",{"type":94,"coordinates":95},"Point",[96,97],-90.19789,38.62727,{"lat":97,"lon":96},[100,101,102],{"name":75,"role":79,"phone":80,"phoneExt":15,"email":81},{"name":83,"role":79,"phone":84,"phoneExt":15,"email":85},{"name":103,"role":104,"phone":15,"phoneExt":15,"email":15},"Kamilah Scales, MD","SUB_INVESTIGATOR",{"type":106,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","100653157","improving-colorectal-cancer-screening-uptake-through-education-and-stool-based-testing-outreach-100653157",false,"NCT07781774","Improving Colorectal Cancer Screening Uptake Through Education and Stool-Based Testing Outreach","Improving Colorectal Cancer Screening Uptake Through Patient-Centered Education and Mailed Stool-Based Testing Outreach in the Primary Care Medicine Clinic","Phase 1 Education Arm Inclusion Criteria:\n\n* Previously enrolled in prior study IRB #202202059 who agreed to participate in future research\n\nPhase 1 Education Arm Exclusion Criteria:\n\n* Not enrolled in prior study IRB #202202059\n\nPhase 2 (All Other Arms) Inclusion Criteria:\n\n* Primary Care Medicine Clinic patient (PRMC)\n* Eligible for CRC screening\n* Between age 45-75 years old\n* Have eligible health insurance\n\nPhase 2 (All Other Arms) Exclusion Criteria:\n\n* Prior history of colorectal cancer\n* Diagnosis of inflammatory bowel disease",true,"ALL","45 Years","75 Years",{"count":119,"type":120},200,"ESTIMATED","INTERVENTIONAL",[123],"NA","This is a mixed-methods implementation pilot combining an educational intervention with a mailed stool-based testing outreach feasibility study within a resident primary care clinic. Participants will be assigned by clinic team to education, mailed FIT, mailed Cologuard, or usual care comparison groups.",[126,127,128,129,130],"Colorectal Cancer (CRC) Screening","CRC Screening","Rectal Cancer","Colon Cancer","Colorectal Cancer",[132,133,134,135],"Colorectal cancer","Screening","Primary care","Teaching clinics","NOT_YET_RECRUITING","2026-08-19",{"date":139,"type":140},"2026-08-24","ACTUAL",{"date":142,"type":120},"2026-09-30",{"date":144,"type":120},"2029-03-31",{"name":5,"class":6},1]