[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540362":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":50,"collaborators":18,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":18,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":18,"overallStatus":34,"whyStopped":18,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Georgetown University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Telehealth Intervention (THI) arm","EXPERIMENTAL","The THI is a 6-month intervention. Participants randomized to THI arm will engage in 6,1-hour virtual sessions with trained study personnel. Modules contain a 1) participant check-in, 2) content designed to build oral health literacy and self-efficacy, 3) and goal-setting.\n\nCoaches will use a facilitation guide, layered with motivational interviewing to conduct telehealth sessions. Participants will also receive biweekly text messages aligned with module content. Post-intervention follow-up will occur at 6- and 12-month post-randomization.",[13],"Behavioral: Telehealth Intervention (THI)",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care (UC) arm","NO_INTERVENTION","This group will receive biweekly text messages on general health behaviors as a retention strategy. This arm will receive no other outside interventions. The Dental Resource directory will be provided to all participants.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Telehealth Intervention (THI)","The THI is a 6-month intervention. On a monthly basis, the survivor will be queried via telehealth (zoom or smart phone) oral and health related symptoms by nurse practitioner or navigator. Based on the initial imaging and the monthly assessments, the patients will be provided with tools and instructions for oral health maintenance which may consist of mucositis management and\u002For diet and lifestyle counseling. All participants will be provided a Resource directory that is to be used to identify a dentist that is best suited for him\u002Fher. Post intervention, follow-up assessments will be conducted at 6-, 9- and 12-months post randomization.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Smith","CONTACT","202-687-5367","ds1924@georgetown.edu",[32],{"facility":33,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Georgetown Lombardi Office of Minority Health","RECRUITING","Washington D.C.","District of Columbia","20003","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-77.03637,38.89511,{"lat":44,"lon":43},[47],{"name":48,"role":28,"phone":29,"phoneExt":18,"email":49},"N. Lewis","flossproject@georgetown.edu",{"type":51,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100540362","floss-project-facilitated-lessons-on-oral-and-systemic-health-in-survivors-100540362",false,"NCT06315855","F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)","Inclusion Criteria:\n\n* male and female cancer survivors who are either ≥ 6 months after competing primary therapy for cancer treatment (N=100)\n* between 25-75 years of age\n* all race\u002Fethnic groups\n* own a smart phone.\n\nExclusion Criteria:\n\n* all head and neck\u002Foral cancer survivors\n* less then 25 years and older than 75 years of age\n* recurrence\u002Fsecond cancers or undergoing treatment\n* unable to provide informed consent.","ALL","25 Years","75 Years",{"count":62,"type":63},100,"ESTIMATED","INTERVENTIONAL",[66],"NA","The investigators will conduct a 2-arm 6-month randomized clinical controlled trial to evaluate the effectiveness of an oral Telehealth Intervention (THI) in preventing cancer-related oral complications, improving oral health maintenance and oral health related quality of life, and reducing systemic inflammation compared to Usual Care (UC) among unselected cancer survivors.",[69,70,71],"Oral Mucositis","Periodontal Diseases","Cancer","2026-01-20",{"date":74,"type":75},"2026-01-22","ACTUAL",{"date":77,"type":75},"2024-08-20",{"date":79,"type":63},"2027-08-25",{"name":5,"class":6},1]