[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07345676":3,"trial-entities:NCT07345676":109,"trial-summary:NCT07345676":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":15,"eligibility_criteria":78,"std_ages":85,"locations":88,"central_contacts":98,"overall_officials":104,"references":107,"see_also_links":108},"NCT07345676","2000041322","Colorectal Cancer Screening Outreach","Optimizing Evidence-Based Interventions to Improve Colorectal Cancer Screening Adherence in Community Health Clinics","RECRUITING","2027-07","2026-07","2026-07-07","2026-06-23","Yale University","OTHER",false,"This is a 4 arm pragmatic trial to test a multicomponent intervention designed to improve adherence to colorectal cancer screening.",null,[19],"Colo-rectal Cancer",[21],"Screening adherence","INTERVENTIONAL","SCREENING",[25],"NA",{"count":27,"type":28},2000,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","Bundled messaging intervention","A bundled intervention of text message, letter, and provider reminder. Text message content using behaviorally motivated messages will vary.",[35,36,37],"Messaging Group A","Messaging Group B","Messaging Group C",[39],{"measure":40,"description":41,"timeFrame":42},"Number of participants with scheduled or completed colorectal cancer screening.","Number of participants who completed or scheduled screening (colonoscopy or stool-based test) within 3 months of randomization.","up to 3 months from randomization",[44,48,52,56,59,63,66,70,72],{"measure":45,"description":46,"timeFrame":47},"Number of participants with abnormal stool-based test that complete a diagnostic colonoscopy.","Number of participants with abnormal stool-based test who complete a diagnostic colonoscopy within 90 days of intervention.","up to 90 days from intervention",{"measure":49,"description":50,"timeFrame":51},"Number of participants who complete screening.","Number of participants who complete screening (stool-based testing or colonoscopy) within 90 days of randomization.","up to 90 days from randomization",{"measure":53,"description":54,"timeFrame":55},"Number of participants who achieve the primary endpoint.","Number of participants who achieve the primary endpoint (screening or scheduling of screening) at 6 months post randomization.","6 months post randomization",{"measure":57,"description":58,"timeFrame":51},"Number of participants who achieve the primary endpoint by message type.","Number of participants who achieve the primary endpoint (screening scheduling or completion rate at 90 days) by message type (message A\u002FB\u002FC).",{"measure":60,"description":61,"timeFrame":62},"Number of participants who complete screening within 6 months of initial outreach.","Number of participants who complete screening within 6 months of initial outreach by text message type (message A\u002FB\u002FC).","up to 6 months from initial outreach",{"measure":64,"description":65,"timeFrame":62},"Number of participants who complete screening colonoscopy within 6 months of initial outreach.","Number of participants who complete screening colonoscopy within 6 months of initial outreach by text message type (message A\u002FB\u002FC).",{"measure":67,"description":68,"timeFrame":69},"Number of participants who provide any response.","Number of participants who provide any response to text messages by message type (message A\u002FB\u002FC).","7, 14, 21, and 90 days",{"measure":71,"description":71,"timeFrame":55},"Number of participants who achieve the primary outcome from among those who did and did not respond to any text message.",{"measure":73,"description":74,"timeFrame":55},"Number of providers who respond to reminders.","Number of providers who respond to provider reminders through MyChart message, phone call, or in-clinic discussion.","ALL","45 Years","75 Years",{"inclusion":79,"exclusion":83,"raw_text":84},[80,81,82],"Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or \\>1 adult medicine visits in the last year).","Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-365 days prior to randomization.","Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.",[],"Inclusion Criteria:\n\n* Established adult medicine patient at Cornell Scott Hill health (defined as having a CSHH primary care doctor or \\>1 adult medicine visits in the last year).\n* Incomplete colorectal cancer screening test defined as an outstanding order for colonoscopy or stool-based CRC screening (e.g., fecal immunochemical test (FIT) or FIT-DNA testing), but no evidence of test completion at the time of randomization. Orders must have been placed between 90-365 days prior to randomization.\n\nOR\n\n* Abnormal stool-based test without follow-up, defined as an abnormal stool-based test result (e.g., positive FIT or FIT-DNA) with no completed diagnostic colonoscopy within 90 days of the result. Patients who meet this criterion will be included in a non randomized arm of the study.\n\nExclusion Criteria:\n\n* Because this is a pragmatic study of a behavioral intervention to improve colorectal cancer screening adherence, any participants who otherwise meet the inclusion criteria will not be excluded.",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"status":8,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"Cornell Scott Hill Health","New Haven","Connecticut","06519","United States",{"lat":96,"lon":97},41.30815,-72.92816,[99],{"name":100,"role":101,"phone":102,"email":103},"Ilana Richman, MD","CONTACT","203 737 1024","ilana.richman@yale.edu",[105],{"name":100,"affiliation":13,"role":106},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Colorectal Carcinoma",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study that aims to enroll 2000 participants. It is a pragmatic trial with four different groups testing the intervention.","completed","Colorectal Cancer Screening Outreach Study","This study is testing a \"bundled messaging intervention\" to see if it can help more people get screened for colorectal cancer. This intervention includes text messages, letters, and reminders from your healthcare provider. The text messages will use different ideas to encourage healthy behaviors. We are looking for people aged 45 to 75 who are already patients at Cornell Scott Hill Health and are due for a colorectal cancer screening. The main goal is to see how many people schedule or complete their screening within three months of joining the study. The current status of this study is unclear.","Participants will be followed for up to 3 months from when they join the study to see if they schedule or complete their colorectal cancer screening.",99,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]