[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06190730":3,"trial-entities:NCT06190730":91,"trial-summary:NCT06190730":96},{"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":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":41,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":14,"eligibility_criteria":53,"std_ages":57,"locations":60,"central_contacts":78,"overall_officials":88,"references":89,"see_also_links":90},"NCT06190730","STUDY00007172","REmote Symptom COllection to improVE postopeRative Care","RECRUITING","2027-12-31","2025-01","2025-04-03","2024-07-23","Medstar Health Research Institute","OTHER",false,"There are vulnerabilities in post-discharge care transition for patients after undergoing resection of malignant gastrointestinal tumors. This study aims to investigate the possibility of utilizing Voice-Assisted Remote Symptom Monitoring System (VARSMS) to alleviate some of these challenges.","Randomized controlled trial comparing post-op patients randomized to using the VARSMS vs control.",[18,19,20,21],"Gastrointestinal Cancer","Gastrointestinal Tumor","Gastrointestinal Tumor Surgery","Gastrointestinal Surgery",[23,24,25],"speech system","large language model","ai","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},281,"ESTIMATED",[34],{"type":13,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"Voice-Assisted Remote Symptom Monitoring System (VARSMS)","Utilizing an Alexa Skill activated via an Amazon Echo Dot device, this system will administer two patient-reported outcomes measures to subjects. This will not be used as basis for diagnosis, nor for any clinical intervention.",[38],"Voice-Assisted Remote Symptom Monitoring System (VARSMS) group",[40],"Voice-Assisted Remote Symptom Monitoring System (VARSMS)- customization phase",[42],{"measure":43,"description":44,"timeFrame":45},"Custom questionnaire based on NCI PRO CTCAE (National Cancer Institute- Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events)","Daily symptom-based self-reported assessment on dyspnea, fever, melena, pain, wound healing, activities of daily living, sensorium, gastrointestinal motility, dysphagia, pitting edema, mood, and an option to mention symptoms not asked of.\n\nThis is monitored by the research team, and any concerning finding, at the discretion of the site's physician, will be relayed to the subject's treating physician.\n\nTreating physician has final decision on whether to address referral by adjustment of management.","40 days",[47],{"measure":48,"description":49,"timeFrame":45},"SASSI (Subjective Assessment of Speech System Interfaces)","After interacting with the speech system for 40 days from the day after discharge, this questionnaire assesses the patient on their experience, having them rate the system based on system response accuracy, likeability, cognitive demand, annoyance, habitability, and speed.","ALL","18 Years",null,{"inclusion":54,"exclusion":55,"raw_text":56},[],[],"Inclusion criteria\n\n1. At least 18 years old. Ages of subjects \\>89 will simply be reported as \\>90.\n2. Scheduled for a GI surgery for management of a tumor in a participating hospital.\n3. Fluent in oral and written English.\n4. Has consistent and continued full access to an operational Wi-Fi for the duration of the study.\n\nExclusion criteria\n\n1. Unable to provide informed consent.\n2. Not willing to commit to regular participation in the study to include daily use (40 days) of the study application.\n3. Life expectancy of less than 60 days.\n4. In the opinion of the investigator, participation in this study is contraindicated.",[58,59],"ADULT","OLDER_ADULT",[61,70],{"facility":62,"status":7,"city":63,"state":64,"zip":65,"country":66,"geoPoint":67},"MedStar Health","Baltimore","Maryland","21218","United States",{"lat":68,"lon":69},39.29038,-76.61219,{"facility":71,"status":7,"city":72,"state":73,"zip":74,"country":66,"geoPoint":75},"Creighton University","Omaha","Nebraska","68124",{"lat":76,"lon":77},41.25626,-95.94043,[79,84],{"name":80,"role":81,"phone":82,"email":83},"Nawar Shara, PhD","CONTACT","301-502-0339","nawar.shara@medstar.net",{"name":85,"role":81,"phone":86,"email":87},"Crisanto Macaraeg, MD","410-261-8218","crisanto.l.macaraeg@medstar.net",[],[],[],{"nct_id":4,"conditions":92,"biomarkers":95},[93,94],"Digestive System Neoplasm","Malignant Digestive System Neoplasm",[],{"nct_id":4,"found":97,"summary":98,"prompt_version":108},true,{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is a randomized controlled trial comparing patients who use the VARSMS with a control group. It plans to enroll 281 participants.","completed","Voice-Assisted Remote Symptom Monitoring for Gastrointestinal Cancer Surgery","This study is testing a Voice-Assisted Remote Symptom Monitoring System (VARSMS) to improve care after surgery for gastrointestinal (GI) cancer. If you are at least 18 years old, speak English, and have reliable Wi-Fi, you might be able to join. You would be scheduled for GI surgery for a tumor at a participating hospital. The VARSMS uses an Amazon Echo Dot to ask you questions about your symptoms. The study will measure your symptoms using a special questionnaire 40 days after surgery. This system is not used for diagnosis or treatment. The study is currently unclear about its recruitment status.","Your symptoms will be measured 40 days after surgery.",100,"You would use an Alexa Skill on an Amazon Echo Dot device to answer questions about your symptoms.","Not stated in the trial record.",[35],"v2"]