[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07517692":3,"trial-entities:NCT07517692":147,"trial-summary:NCT07517692":151},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":45,"sex":104,"minimum_age":105,"maximum_age":106,"healthy_volunteers":14,"eligibility_criteria":107,"std_ages":126,"locations":129,"central_contacts":139,"overall_officials":140,"references":145,"see_also_links":146},"NCT07517692","STUDY00001107","Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening","ENROLLING_BY_INVITATION","2028-03-01","2026-05","2026-05-14","2026-04-07","University of Massachusetts, Worcester","OTHER",false,"The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are:\n\n* Does the patient and provider support increase the number of patients who complete lung cancer screening?\n* Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening?\n* Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening.\n\nPrimary care provider participants will:\n\n* Receive the provider support session and educational materials, or follow usual practice\n* Answer a baseline survey and a follow-up survey in 6 months\n* Answer additional survey questions regarding the acceptability of the provider support session if they receive it\n\nPatient participants will\n\n* Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care\n* Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.","Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).\n\nThe investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.",[18],"Lung Cancer Screening",[20,18,21],"Shared Decision Making","health informatics","INTERVENTIONAL","SCREENING",[25],"NA",{"count":27,"type":28},120,"ESTIMATED",[30,35],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","FIX-SDM","Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system.\n\nPatients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.",[32],{"type":31,"name":36,"description":37,"armGroupLabels":38},"Usual Care","PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice).\n\nPatients will receive the usual care",[39],"Comparator: Usual Care",[41],{"measure":42,"description":43,"timeFrame":44},"Completion of Lung Cancer Screening (LCS) within 3 months","The proportion of patients in each arm who completed LCS within 3 months of the index primary care visit","3 months after the index visit",[46,50,54,57,61,64,67,71,74,78,81,84,87,90,94,98,101],{"measure":47,"description":48,"timeFrame":49},"Completion of LCS within 6 months","The proportion of patients in each arm who completed LCS within 6 months of the index primary care visit","6 months after the index visit",{"measure":51,"description":52,"timeFrame":53},"LCS order","The proportion of patients in each arm who had a LCS order in the electronic health record (EHR)","3 and 6 months after the index visit",{"measure":55,"description":56,"timeFrame":53},"LCS appointment","The proportion of patients in each arm who had an appointment for LCS scheduled in the EHR",{"measure":58,"description":59,"timeFrame":60},"Patient-reported LCS discussion","The proportion of patients in each arm who had LCS discussions with providers during their visits, assessed by the patient survey items","Within 10 days after the index visit",{"measure":62,"description":63,"timeFrame":60},"Content of LCS discussion","The mean number of LCS topics discussed during the visits, assessed by the patient survey items in each arm",{"measure":65,"description":66,"timeFrame":60},"Patient perceived quality of LCS discussion","The mean score of the Patient Assessment of Cancer Communication Experiences (PACE) survey in each arm",{"measure":68,"description":69,"timeFrame":70},"Patient-reported shared decsion making (SDM) for LCS","The mean score of the SDM Process 4, assessed during the patient survey in each arm","Within 10 days after the index visit.",{"measure":72,"description":73,"timeFrame":70},"Patient knowledge of LCS","The mean number of LCS knowledge question items answered correctly in each arm, assessed during the patient survey in each arm",{"measure":75,"description":76,"timeFrame":77},"Patient decisional conflict","The mean score of the Decisional Conflict Scale in each arm, assessed during the patient survey in each arm","Within 10 days after the index visit and 3 months after the index visit",{"measure":79,"description":80,"timeFrame":70},"Patient acceptability of FIX-SDM","Acceptability of FIX-SDM among patients in the FIX-SDM arm, assessed by the survey items",{"measure":82,"description":83,"timeFrame":44},"Patient decision satisfaction","Patient decision satisfaction in each arm assessed by a 10-point Likert scale",{"measure":85,"description":86,"timeFrame":44},"Patient decision regret","Patient decision regret in each arm assessed by the Decision Regret Scale",{"measure":88,"description":89,"timeFrame":44},"Patient decision intention to follow-up LCS","Patient decision intention to adhere to follow-up LCS in each arm, assessed by a 5-point Likert scale",{"measure":91,"description":92,"timeFrame":93},"Provider acceptability of FIX-SDM","Acceptability of FIX-SDM among providers in the FIX-SDM arm, assessed by provider survey items","Immediately after the PCP intervention",{"measure":95,"description":96,"timeFrame":97},"Provider report on decision aid use","Frequency of decision aid use measured by a 5-point Likert scale in each arm","6 months after the provider baseline survey",{"measure":99,"description":100,"timeFrame":97},"Provider reports on the content of the LCS discussion","Frequency of the content of LCS discussion measured by a 5-point Likert scale in each arm",{"measure":102,"description":103,"timeFrame":97},"Sustainability of shared decision making for LCS","Sustainability of shared decision-making for LCS assessed by the Normalization Measure Development Questionnaire in a provider survey in each arm","ALL","50 Years","77 Years",{"inclusion":108,"exclusion":116,"raw_text":125},[109,110,111,112,113,114,115],"PCPs (physicians or advanced practitioners)","Who practice in general internal medicine or family medicine clinics in UMass Memorial Health","Adults between the ages of 50 and 77","Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)","Has a smartphone with texting capability","English-speaking","Has a scheduled PCP visit in the next \\~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study",[117,118,119,120,121,122,123,124],"Participation in the previous study to co-develop the provider intervention (to avoid bias)","Prior LCS","Chest CT within the last 12 months","History of lung cancer","Active cancer requiring treatment","Supplemental oxygen use","Pregnancy","Participation in the previous study to co-develop the patient intervention (to avoid bias)","Primary care provider (PCP) participants:\n\nInclusion criteria\n\n* PCPs (physicians or advanced practitioners)\n* Who practice in general internal medicine or family medicine clinics in UMass Memorial Health\n* Who care for more than 5 potentially LCS-eligible patients in their practice Exclusion criteria\n* Participation in the previous study to co-develop the provider intervention (to avoid bias)\n\nPatient participants\n\nInclusion Criteria:\n\n* Adults between the ages of 50 and 77\n* Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)\n* Has a smartphone with texting capability\n* English-speaking\n* Has a scheduled PCP visit in the next \\~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study\n\nExclusion Criteria:\n\n* Prior LCS\n* Chest CT within the last 12 months\n* History of lung cancer\n* Active cancer requiring treatment\n* Supplemental oxygen use\n* Pregnancy\n* Participation in the previous study to co-develop the patient intervention (to avoid bias)",[127,128],"ADULT","OLDER_ADULT",[130],{"facility":131,"city":132,"state":133,"zip":134,"country":135,"geoPoint":136},"University of Massachusetts Chan Medical School","Worcester","Massachusetts","01605","United States",{"lat":137,"lon":138},42.26259,-71.80229,[],[141],{"name":142,"affiliation":143,"role":144},"Mayuko Ito Fukunaga, MD, MSc","UMass Chan Medical School","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":148,"biomarkers":150},[149],"Lung Carcinoma",[],{"nct_id":4,"found":14,"summary":152,"prompt_version":152},null]