[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554321":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":46,"centralContacts":53,"locations":59,"responsibleParty":94,"collaborators":96,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":29,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":29,"enrollmentInfo":109,"targetDuration":29,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":61,"whyStopped":29,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"STRONG Intervention","EXPERIMENTAL","Participants will receive an initial consultation and biweekly follow-up visits with a study dietitian for 90 days.\n\nDuring the follow-up visits, the study dietitian will review the dietary plan and goals, review the dietary food log, and discuss any challenges with dietary intake and recommendations for improving dietary intake.\n\nParticipants will keep a daily diary of food intake with a Fitbit smartphone app and a Fitbit wearable device for 90 days, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.",[13,14,15,16],"Behavioral: Dietitian Consultation","Behavioral: Survey","Behavioral: Fitbit Data Collection","Behavioral: Social Determinants of Health Survey (SDOH)",{"label":18,"type":19,"description":20,"interventionNames":21},"Usual Care Intervention","ACTIVE_COMPARATOR","Participants will be referred to a study dietitian based on their standard-care clinician's discretion, complete 6 questionnaires, and have the option to participate in a voluntary interview about the intervention.",[13,14,22],"Behavioral: Referral to Dietitian",[24,30,34,38,42],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"BEHAVIORAL","Dietitian Consultation","Participants will meet with a dietitian who will provide individualized nutrition counseling and dietary goals for calorie and protein intake.\n\nBi-weekly, 30-minute dietitian telehealth visits will be conducted via ZOOM videoconferencing at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.",[9,18],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Survey","Surveys will be conducted using the PG-SGA short form19-21 and a brief symptom assessment tool that captures additional nutrition-impact symptoms not captured by the PG-SGA (e.g., swallowing difficulty) measured by the FACT Esophageal and Gastric Cancer scales and the FAACT anorexia\u002Fcachexia scales 22,23 through REDCap.\n\nSurveys are completed at the pre-intervention baseline visit and monthly during the intervention period prior to the dietitian visits (up to 90 days), and at the 4 and 6 month timepoints post-intervention.",[9,18],{"type":25,"name":35,"description":36,"armGroupLabels":37,"otherNames":29},"Fitbit Data Collection","Participants will log food intake while sharing their data with a dietitian during the 30-minute dietitian telehealth visits at the pre-intervention baseline visit, monthly during the intervention period (up to 90 days) and at the 4 and 6 month timepoints post-intervention.",[9],{"type":25,"name":39,"description":40,"armGroupLabels":41,"otherNames":29},"Referral to Dietitian","Usual Care condition referral to a dietitian based on physician discretion.",[18],{"type":25,"name":43,"description":44,"armGroupLabels":45,"otherNames":29},"Social Determinants of Health Survey (SDOH)","Participants will complete a SDOH Survey that captures individual-level factors (insurance type, preferred language, educational attainment, annual household income, digital health literacy, financial toxicity, and self-reported barriers to care \\[e.g., transportation\\]) and structural-level factors (neighborhood disadvantage, rural residence).\n\nDigital health literacy will be measured using the validated eHEALS scale, an 8-item measure assessing confidence with finding, evaluating, and applying electronic information to inform health decision-making (score ≤ 30 indicates low literacy).",[9],[47,51],{"name":48,"affiliation":49,"role":50},"Amir Alishahi Tabriz, MD, PhD, MPH","Moffitt Cancer Center","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":49,"role":50},"Jose Pimiento, MD",[54],{"name":55,"role":56,"phone":57,"phoneExt":29,"email":58},"Emma Hume","CONTACT","813-745-6426","Emma.Hume@moffitt.org",[60,78],{"facility":49,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-82.45843,27.94752,{"lat":71,"lon":70},[74,75,77],{"name":55,"role":56,"phone":57,"phoneExt":29,"email":58},{"name":76,"role":50,"phone":29,"phoneExt":29,"email":29},"Amir Alishahi Tabriz, MD, phD, MPH",{"name":52,"role":50,"phone":29,"phoneExt":29,"email":29},{"facility":79,"status":61,"city":80,"state":81,"zip":82,"country":65,"countryCode":66,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"UNC Lineberger Comprehensive Cancer Center","Chapel Hill","North Carolina","27599",{"type":68,"coordinates":84},[85,86],-79.05584,35.9132,{"lat":86,"lon":85},[89,93],{"name":90,"role":56,"phone":91,"phoneExt":29,"email":92},"Kea Turner, PhD, MPH, MA","919-966-4432","Kea.Turner@unc.edu",{"name":90,"role":50,"phone":29,"phoneExt":29,"email":29},{"type":95,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[97],{"name":98,"class":99},"United States Department of Defense","FED","100554321","support-through-remote-observation-and-nutrition-guidance-program-for-individuals-with-gastroesophageal-cancer-100554321",false,"NCT06497569","Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer","Support Through Remote Observation and Nutrition Guidance Program for Individuals With Gastroesophageal Cancer (STRONG-GEC)","Inclusion Criteria:\n\n* Participants must be 18 years of age or older\n* Participants must have locally advanced or metastatic gastroesophageal cancer (GEC)\n* Participants must plan to initiate chemotherapy and\u002For radiation therapy with a plan to have surgery or definitive treatment follow up at Moffitt\n* Participants must be able to speak and read Spanish and\u002For English\n* Participants must be able to provide informed consent\n\nExclusion Criteria:\n\n* Participants have a documented or observable psychiatric or neurological disorder that would interfere with study participation (e.g. severe dementia)\n* Use of feeding tubes at the time of study enrollment","ALL","18 Years",{"count":110,"type":111},80,"ESTIMATED","INTERVENTIONAL",[114],"NA","The purpose of this study is to determine how the STRONG intervention compares with usual care for reducing malnutrition among gastroesophageal cancer patients.",[117],"GastroEsophageal Cancer",[119],"Nutrition Support","2026-03-31",{"date":122,"type":123},"2026-04-01","ACTUAL",{"date":125,"type":123},"2024-07-26",{"date":127,"type":111},"2027-06",{"name":5,"class":6},2]