[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06246409":3,"trial-entities:NCT06246409":109,"trial-summary:NCT06246409":113},{"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":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":43,"secondary_outcomes":48,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":14,"eligibility_criteria":70,"std_ages":82,"locations":85,"central_contacts":103,"overall_officials":105,"references":107,"see_also_links":108},"NCT06246409","UF-CCPS-038","Modernizing Instructions to Improve Treatment Participation of Subjects During Their First Radiotherapy","RECRUITING","2026-12","2026-03","2026-03-04","2024-12-24","University of Florida","OTHER",false,"Daily patient participation is critical to the successful, life-saving delivery of radiotherapy. There is very little in the literature describing the best way to prepare patients to give optimal participation. This study aims to look at an already-prepared conversion of patient instruction materials and measure whether the improvement in clarity and specificity produces the desired changes in patient decision-making and emotional comfort.",null,[18],"Cancer",[20,21,22,23],"patient comfort","patient participation","external beam radiotherapy","radiation oncology","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},650,"ESTIMATED",[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","Modernized patient instructions","Patients will be given modernized patient instructions prior to radiotherapy treatment.",[37],"Arm 2: Modernized patient instructions",{"type":33,"name":39,"description":40,"armGroupLabels":41},"Existing patient instructions","Patients will be given the patient instructions currently in use prior to radiotherapy treatment.",[42],"Arm 1: Existing patient instructions",[44],{"measure":45,"description":46,"timeFrame":47},"Unintentional missed treatment days","Determine the number of unintentional missed days of treatment during a course of radiotherapy","8 weeks",[49,52,55,58,61,64],{"measure":50,"description":51,"timeFrame":47},"Patient-reported comfort","Evaluate patient-reported comfort with participation in radiotherapy.",{"measure":53,"description":54,"timeFrame":47},"Unplanned clinic visits","Determine the average number of unplanned clinic visits during radiotherapy.",{"measure":56,"description":57,"timeFrame":47},"Emergency department visits","Determine the average number of emergency department visits during radiotherapy.",{"measure":59,"description":60,"timeFrame":47},"Hospitalizations","Determine the average number of hospitalizations during radiotherapy.",{"measure":62,"description":63,"timeFrame":47},"Rate of treatment completion","Determine the rate of completion of the prescribed number of radiotherapy treatments.",{"measure":65,"description":66,"timeFrame":47},"Patient participation in treatment","Determine the percentage of patients fully participating in their radiotherapy treatment, as assessed by Likert scale ratings given by the therapist. Patients will be rated by the therapist on factors such as correct patient-initiated alignment of body, holding still, and following breath-hold directions.","ALL","18 Years","99 Years",{"inclusion":71,"exclusion":74,"raw_text":81},[72,73],"Patients ≥ 18 years old planning their first external beam radiotherapy","Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.",[75,76,77,78,79,80],"Have received external beam radiotherapy in the past","External beam radiotherapy is initiated as inpatient.","External beam radiotherapy consists of less than 3 fractions.","Planned radiotherapy that does not employ an external beam","Planned participation in a clinical study that prohibits participation in a second, concurrent treatment trial","Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.","Inclusion Criteria:\n\n* Patients ≥ 18 years old planning their first external beam radiotherapy\n* Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures.\n\nExclusion Criteria:\n\n* Have received external beam radiotherapy in the past\n* External beam radiotherapy is initiated as inpatient.\n* External beam radiotherapy consists of less than 3 fractions.\n* Planned radiotherapy that does not employ an external beam\n* Planned participation in a clinical study that prohibits participation in a second, concurrent treatment trial\n* Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":12,"status":7,"city":87,"state":88,"zip":89,"country":90,"contacts":91,"geoPoint":100},"Gainesville","Florida","32608","United States",[92,97],{"name":93,"role":94,"phone":95,"email":96},"Amy Carrao-Tackett","CONTACT","352-265-8826","amy.carrao-tackett@ufhealth.org",{"name":98,"role":99},"Alexandra De Leo, MD","PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},29.65163,-82.32483,[104],{"name":93,"role":94,"phone":95,"email":96},[106],{"name":98,"affiliation":12,"role":99},[],[],{"nct_id":4,"conditions":110,"biomarkers":112},[111],"Malignant Neoplasm",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This interventional study plans to enroll 650 participants. It compares two groups: one receiving modernized patient instructions and another receiving existing patient instructions.","completed","Improving Patient Instructions for Radiotherapy","This study is looking at how different patient instructions affect participation in your first external beam radiotherapy (a type of radiation treatment for cancer). We want to see if modernized patient instructions, which are clearer and more specific, can help you better understand your treatment and feel more comfortable, compared to the existing patient instructions. The main goal is to see if these new instructions can reduce the number of unintentional missed treatment days over 8 weeks. You can join if you are 18 to 99 years old, planning your first external beam radiotherapy, and have not had this type of radiation before. The current status of this study is unclear.","The primary outcome, unintentional missed treatment days, will be measured at 8 weeks.",111,"Not specified in the trial record.","Not stated in the trial record.",[34,39],"v2"]