[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100512414":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":47,"studyPopulation":42,"armGroups":48,"interventions":70,"overallOfficials":88,"centralContacts":95,"locations":104,"responsibleParty":145,"collaborators":148,"id":154,"slug":155,"hasResults":156,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":42,"eligibilityCriteria":160,"healthyVolunteers":156,"sex":161,"minAge":162,"maxAge":42,"enrollmentInfo":163,"targetDuration":42,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":172,"overallStatus":120,"whyStopped":42,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":185},{"fullName":5,"class":6},"Abramson Cancer Center at Penn Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Adoption","Defined as the initiation of cervical cancer treatment within 90 days of randomization.","Within 90 days of randomization",[14,18,21,24,27],{"measure":15,"description":16,"timeFrame":17},"Fidelity","Defined as completion of evidence-based cancer treatment according to international guidelines and measured using medical record data.","12 months after randomization",{"measure":19,"description":20,"timeFrame":17},"Reach: First Appointment","Defined by the proportion of patients who complete an initial treatment visit divided by those randomized",{"measure":22,"description":23,"timeFrame":17},"Reach: First Stage","Defined by the proportion of patients who complete an enhanced outreach phone call divided by those contacted.",{"measure":25,"description":26,"timeFrame":17},"Reach: Second Stage","Defined by the proportion of patients who complete a patient navigation phone call (high touch strategy) divided by those contacted.",{"measure":28,"description":29,"timeFrame":17},"Reach: Results","Defined by the proportion of patients with confirmation of results received divided by those randomized.",[31,34],{"measure":32,"description":33,"timeFrame":17},"Clinical Outcomes: Treatment","Defined by the stage at diagnosis, type of cancer treatment the patient received (e.g., chemoradiation, surgery) measured using medical record data.",{"measure":35,"description":36,"timeFrame":17},"Clinical Outcomes: Survival","Defined as overall survival at one year after randomization measured using medical record data.",{"allocation":38,"interventionModel":39,"interventionModelDescription":40,"primaryPurpose":41,"observationalModel":42,"timePerspective":42,"maskingInfo":43},"RANDOMIZED","SEQUENTIAL","Pragmatic Sequential Multiple Assignment Randomized Trial (SMART).\n\nThis study uses a sequential randomization design in which all eligible participants will be randomized into one of two interventions at Stage 1 and then participants that do not respond to Stage 1 interventions will be randomized to receive Stage 2 interventions","HEALTH_SERVICES_RESEARCH",null,{"masking":44,"maskingDescription":42,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR","Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a hybrid (type III) and pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design. The adaptive strategies are designed to target patient- and system-level determinants identified in preliminary data, including delayed communication of results, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics. The strategies draw upon key principles in behavioral economics and are supported by systematic evidence of the effectiveness of nudge strategies in preventive, HIV, and cancer care. The overarching rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach and nudge strategies will increase timely treatment adoption and be scalable and sustainable in the long-term.",[49,56,61,66],{"label":50,"type":51,"description":52,"interventionNames":53},"Stage 1 Clinic Outreach + Stage 2 Low Touch","EXPERIMENTAL","All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).",[54,55],"Behavioral: Clinic Outreach","Behavioral: Low-Touch Strategy",{"label":57,"type":51,"description":58,"interventionNames":59},"Stage 1 Clinic Outreach + Stage 2 High Touch","All participants receive direct clinic outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation (stage 2).",[54,60],"Behavioral: High-Touch Strategy",{"label":62,"type":51,"description":63,"interventionNames":64},"Stage 1 Enhanced Outreach + Stage 2 Low-Touch","All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging (stage 2).",[65,55],"Behavioral: Enhanced Outreach",{"label":67,"type":51,"description":68,"interventionNames":69},"Stage 1 Enhanced Outreach + Stage 2 High-Touch","All participants receive direct clinic outreach plus enhanced outreach to communicate readiness of results (stage 1). Participants who do not attend the clinic by 30 days (non-responders) will receive asynchronous text message reminders using framed messaging in combination with synchronous patient navigation.",[65,60],[71,76,80,84],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":42},"BEHAVIORAL","Clinic Outreach","A member of the pathology team will contact the referring clinic to communicate the readiness of results.",[57,50],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":42},"Enhanced Outreach","A member of the pathology team will contact both the referring clinic and the patient directly to communicate the readiness of results.",[67,62],{"type":72,"name":81,"description":82,"armGroupLabels":83,"otherNames":42},"Low-Touch Strategy","Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging.",[50,62],{"type":72,"name":85,"description":86,"armGroupLabels":87,"otherNames":42},"High-Touch Strategy","Patient will be sent asynchronous text messaging reminders related to the importance of timely care using framed messaging in combination with synchronous telephone-based patient navigation.",[57,67],[89,93],{"name":90,"affiliation":91,"role":92},"Katharine Rendle, PhD,MSW,MPH","University of Pennsylvania","PRINCIPAL_INVESTIGATOR",{"name":94,"affiliation":91,"role":92},"Surbhi Grover, MD, MPH",[96,100],{"name":90,"role":97,"phone":98,"phoneExt":42,"email":99},"CONTACT","215-349- 5442","katharine.rendle@pennmedicine.upenn.edu",{"name":101,"role":97,"phone":102,"phoneExt":42,"email":103},"Hannah Toneff, MSW, MA","267-882-3186","hannah.toneff@pennmedicine.upenn.edu",[105,118,133],{"facility":91,"status":106,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":42},"ACTIVE_NOT_RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":113,"coordinates":114},"Point",[115,116],-75.16362,39.95238,{"lat":116,"lon":115},{"facility":119,"status":120,"city":121,"state":122,"zip":42,"country":123,"countryCode":124,"cosmosGeoPoint":42,"geoPoint":42,"contacts":125},"Nyangabgwe Referral Hospital","RECRUITING","Francistown","North-East District","Botswana","BW",[126,130],{"name":127,"role":97,"phone":128,"phoneExt":42,"email":129},"Surbhi Grover, MD","2672076977","surbhi.grover@pennmedicine.upenn.edu",{"name":131,"role":97,"phone":42,"phoneExt":42,"email":132},"Irene Ramokate","ramokatei@bup.org.bw",{"facility":134,"status":120,"city":135,"state":42,"zip":42,"country":123,"countryCode":124,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Princess Marina Hospital","Gaborone",{"type":113,"coordinates":137},[138,139],25.90859,-24.65451,{"lat":139,"lon":138},[142,144],{"name":94,"role":97,"phone":42,"phoneExt":42,"email":143},"Surbhi.Grover@pennmedicine.upenn.edu",{"name":94,"role":92,"phone":42,"phoneExt":42,"email":42},{"type":92,"investigatorFullName":146,"investigatorTitle":147,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Katharine Rendle","Principal Investigator",[149,152],{"name":150,"class":151},"National Cancer Institute (NCI)","NIH",{"name":153,"class":6},"University of Botswana","100512414","strategies-to-close-the-gap-from-cervical-cancer-diagnosis-to-treatment-in-botswana-100512414",false,"NCT05952141","Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana","Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap From Cervical Cancer Diagnosis to Treatment in Botswana","Inclusion Criteria:\n\nPatients will be eligible if they:\n\n1. are biological females\n2. are aged 18 or older\n3. have pathology-confirmed invasive cervical cancer diagnosis\n4. have pathology results evaluated at National Health Laboratory in Botswana\n5. are citizens of Botswana\n6. have no prior history of invasive cervical cancer\n\nExclusion Criteria:\n\nPatients will be excluded if they:\n\n1. are biological males or otherwise born without a cervix\n2. are below the age of 18 due to the rarity of cervical cancer in this population\n3. do not meet study inclusion criteria","FEMALE","18 Years",{"count":164,"type":165},610,"ESTIMATED","INTERVENTIONAL",[168],"NA","Investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a pragmatic trial design.",[171],"Cervical Cancer",[173,123,174,175],"Screening","Treatment","Patient","2026-07-21",{"date":178,"type":179},"2026-07-22","ACTUAL",{"date":181,"type":179},"2023-09-01",{"date":183,"type":165},"2027-08-31",{"name":5,"class":6},3]