[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07463547":3,"trial-entities:NCT07463547":66,"trial-summary:NCT07463547":70},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":39,"sex":40,"minimum_age":41,"maximum_age":42,"healthy_volunteers":15,"eligibility_criteria":43,"std_ages":47,"locations":50,"central_contacts":59,"overall_officials":60,"references":64,"see_also_links":65},"NCT07463547","IRB-300007406-2","Wearable Integration in Symptom Evaluation for Cancer Survivors","Evaluating the Implementation and Impact of Navigator-Delivered ePRO Home Symptom Monitoring and Management - Wearable Integration in Symptom Evaluation for Cancer Survivors","ENROLLING_BY_INVITATION","2027-02","2026-04","2026-04-23","2026-04-17","University of Alabama at Birmingham","OTHER",false,"The objective of this work is the production of actionable insights that can be leveraged to improve remote symptom monitoring (RSM) in varied practice settings, which in turn, is expected to improve timely, efficient, and high-quality comprehensive care in oncology. Aim 1: To assess the feasibility of incorporating a wearable into an RSM program for patients receiving cancer treatment. Aim 2: To assess the relationship between the wearable and ePRO-reported physical symptoms and functional status. Aim 3: To characterize barriers and facilitators of using the wearable in the RSM program and suggest approaches to incorporating relevant evidence-based interventions.","Remote symptom monitoring (RSM) using electronic patient-reported outcomes (ePROs) benefits patients with cancer on active treatment (i.e., improved symptom assessment efficiency, patient-clinician communication and satisfaction, symptom control and well-being, overall survival). Despite promising RSM results, low sustained adherence and the limited amount of symptom information that can be feasibly captured through surveys limit RSM benefits. Passive data collection through wearable technology may strengthen RSM benefits by providing a more complete and continuous picture of patient health, without substantial patient and system burden. For this investigation, we leverage our existing RSM infrastructure to test the integration of a wearable for enhanced monitoring.",[19],"Cancer",[],"INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[24],"NA",{"count":26,"type":27},20,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Wearable","Patient participants are provided with an industry-leading wearable with multiple research-grade sensors that measure physiological indicators such as temperature, HRV, sleep, and physical activity, with high accuracy.",[33],"Patient Group - Wearable",[35],{"measure":36,"description":37,"timeFrame":38},"Feasibility thresholds for uptake and compliance","% of eligible patients agree to wearable use and % adherence","6 months",[],"ALL","18 Years",null,{"inclusion":44,"exclusion":45,"raw_text":46},[],[],"Inclusion criteria: (1) ≥18 years of age; (2) diagnosed with cancer; (3) enrolled in the ePRO RSM program at O'Neal CCC; (4) uses a smart phone compatible with the wearable.\n\nExclusion criteria: (1) Lack of English fluency and literacy; (2) Medical condition that makes the person unable to participate, at PI discretion.",[48,49],"ADULT","OLDER_ADULT",[51],{"facility":13,"city":52,"state":53,"zip":54,"country":55,"geoPoint":56},"Birmingham","Alabama","35249","United States",{"lat":57,"lon":58},33.52066,-86.80249,[],[61],{"name":62,"affiliation":13,"role":63},"Gabrielle Rocque, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":67,"biomarkers":69},[68],"Malignant Neoplasm",[],{"nct_id":4,"found":15,"summary":42,"prompt_version":42}]