[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658908":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":25,"studyPopulation":11,"armGroups":26,"interventions":37,"overallOfficials":42,"centralContacts":46,"locations":11,"responsibleParty":54,"collaborators":57,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":11,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":88,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":11},{"fullName":5,"class":6},"University of Washington","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants completing BCS 90 days after initial outreach",null,"90-days",[14],{"measure":15,"description":11,"timeFrame":12},"Proportion of participants who schedule or complete BCS 90 days after initial outreach",{"allocation":17,"interventionModel":18,"interventionModelDescription":11,"primaryPurpose":19,"observationalModel":11,"timePerspective":11,"maskingInfo":20},"RANDOMIZED","PARALLEL","HEALTH_SERVICES_RESEARCH",{"masking":21,"maskingDescription":22,"whoMasked":23},"SINGLE","Investigator doing analysis will be masked",[24],"INVESTIGATOR","Our study purpose is to evaluate the effectiveness of a culturally tailored chatbot intervention to improve access to mammography scheduling and breast cancer screening (BCS) completion among average risk Black women who receive primary care at the University of Washington (UW) and are due for breast cancer screening.\n\nThis is a prospective, pilot randomized controlled trial that will evaluate the effectiveness of an outreach strategy in improving BCS completion via mammography. Individuals eligible for enrollment into the trial will be randomized to the two following interventions:\n\n1. Arm 1: Chatbot intervention: SMS\u002Ftext message with breast cancer screening educational and scheduling information; reminder message at 2-weeks.\n2. Arm 2: Control: usual care.\n\nRandom assignments will be based on a randomization scheme called Big Stick Design with a maximum tolerated imbalance between groups of 4. This design allows random assignments to be generated in a way that limits the imbalance between arms within strata, while ensuring that the sequence is not predictable based on previous assignments. Randomization will be stratified within arms by 1) age (40-55 years vs. 56-74 years - to account for potential differences in recommendations for mammogram frequency and comfort with technology\u002Fchatbots), 2) history of any prior breast cancer screening (prior screener vs. never screener), 3) campaign messaging status (received UW Medicine Population Health breast cancer screening campaign outreach message in August 2026 vs. did not receive outreach message in August 2026).\n\nWe plan to stagger the timing of chatbot outreach based on mammogram access in coordination with the UW radiology department. For example, if there are 20 slots available in the next 2 weeks across sites, we may send chatbot outreach to 100 eligible participants (with expected \\~20% response rate to successful outreach interventions among people overdue for screening). If there is a delay between randomization and intervention group chatbot outreach (i.e. due to staggering), we will confirm if participants have scheduled mammography in interim and are therefore no longer eligible for study participation before intervention outreach messaging is sent.\n\nOur primary outcome of interest is proportion of participants who completed BCS at 90 days following initial chatbot outreach. Our secondary outcome of interest is proportion of participants who scheduled or completed BCS at 90 days following initial chatbot outreach (i.e. measuring implementation effectiveness). We will also perform a sensitivity analysis measuring both primary and secondary outcomes at 180 days following initial chatbot outreach (i.e. to account for delays in scheduling\u002Foutreach).\n\nWe will perform intention-to-treat (ITT) analyses. First, we will use the Pearson's chi-square test of homogeneity to assess for statistically significant differences between randomization group and control group mammogram completion rate at 90 days post chatbot outreach (primary outcome), or mammogram scheduling\u002Fcompletion rate at 90 days post chatbot outreach (secondary outcome). We will then conduct a multivariable logistic regression analysis to test the association between randomization group and mammogram completion at 90 days post chatbot outreach (primary outcome), or mammogram scheduling\u002Fcompletion at 90 days post chatbot outreach (secondary outcome), adjusting for individual- (e.g., age, insurance status, patient portal use, primary care visits in last year, previous BCS), clinic- (e.g., clinic group), and system-level characteristics (e.g. campaigns messaging), including stratification factors, to address covariate imbalance between groups and improve precision in the analysis. We will estimate adjusted risk differences from these models using predictive margins.\n\nFinally, we will conduct unadjusted exploratory subgroup analyses. We will explore intervention effect consistency between: 1) participants who use the patient portal and those who do not use the patient portal; 2) participants who receive primary care through a university hospital-based clinic, county hospital-based clinic, or community-based clinic; 3) among intervention group participants who responded to text messages and\u002For reached scheduling message (i.e. interacted with chatbot) vs. those who did not.",[27,31],{"label":28,"type":29,"description":30,"interventionNames":11},"Usual care","NO_INTERVENTION","Patients in this arm may receive breast cancer screening counseling and\u002For mammogram referral through usual primary care. This could include during primary care visit, patient portal message, phone call or letter.",{"label":32,"type":33,"description":34,"interventionNames":35},"Chatbot intervention","EXPERIMENTAL","Initial chatbot outreach with education and direct mammogram scheduling capability, with one conditional follow-up message at approximately Day 14",[36],"Other: Chatbot",[38],{"type":6,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"Chatbot","Chatbot-based outreach that provides breast cancer screening education, allows participants to learn more about screening, and offers direct mammography scheduling through the chatbot",[32],[43],{"name":44,"affiliation":5,"role":45},"Leah Marcotte, MD, MS","PRINCIPAL_INVESTIGATOR",[47,51],{"name":44,"role":48,"phone":49,"phoneExt":11,"email":50},"CONTACT","206-598-8750","leahmar@uw.edu",{"name":52,"role":48,"phone":11,"phoneExt":11,"email":53},"Olivia Gregorich, MS","olivia02@uw.edu",{"type":45,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Leah Marcotte","Assistant Professor: School of Medicine, General Internal Medicine",[58,61],{"name":59,"class":60},"Novartis Pharmaceuticals","INDUSTRY",{"name":62,"class":63},"National Comprehensive Cancer Network","NETWORK","100658908","design-and-pilot-implementation-of-a-chatbot-to-support-breast-cancer-screening-among-black-women-100658908",false,"NCT07858825","Design and Pilot Implementation of a Chatbot to Support Breast Cancer Screening Among Black Women","Inclusion Criteria:\n\n* Age 40 through 74 years at the time of eligibility assessment.\n* Assigned female at birth.\n* An active UW Medicine primary-care patient and included in the UW Medicine population-health breast cancer screening outreach population.\n* Due for breast cancer screening, defined as having no documented mammogram within the prior 24 months, based on the UW Medicine adaptation of the NCQA HEDIS breast cancer screening measure.\n* Have a mobile phone number on file and opted in to receiving text messages from UW Medicine.\n* Eligible to receive routine breast cancer screening outreach according to UW Medicine clinical and operational criteria.\n\nExclusion Criteria:\n\n* History of bilateral mastectomy.\n* EHR diagnosis or indicator of palliative care, advanced illness, or frailty.",true,"FEMALE","40 Years","74 Years",{"count":75,"type":76},873,"ESTIMATED","INTERVENTIONAL",[79],"NA","Black women are more likely than White women to be diagnosed at later stages and to die from breast cancer. Increasing breast cancer screening rates could help improve early detection of and survival from breast cancer. To this end, this study seeks to implement and evaluate a culturally tailored chatbot intervention to increase breast cancer screening and address inequities among Black women using community-based research approaches.\n\nWe will conduct a pilot randomized quality improvement trial to test the efficacy of a chatbot outreach intervention, which provides breast cancer screening education and direct links to scheduling, on increasing breast cancer screening completion among Black women who receive primary care at the University of Washington (UW) Medicine. We hypothesize that compared to women who receive usual care, women who receive this novel chatbot outreach will have higher breast cancer screening completion rates at 90-days. In addition to quantitative assessment of chatbot effectiveness, we will also qualitatively evaluate chatbot acceptability, feasibility, and message relevance through interviews with a small group of participants about their experiences with the chatbot.",[82],"Breast Cancer",[84,85,86,87],"chatbot","breast cancer screening","mammogram","text message","NOT_YET_RECRUITING","2026-09-29",{"date":91,"type":92},"2026-10-05","ACTUAL",{"date":94,"type":76},"2026-10-26",{"date":96,"type":76},"2027-06-01",{"name":5,"class":6}]