Safety of Telemedicine Follow-Up Visits in Children With Cancer Undergoing Intensive Chemotherapy: Results From the Randomized KULT-SH Trial.
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PURPOSE: Centralization of pediatric oncology care has increased the need for telemedicine. Evidence on its safety in highly vulnerable patients such as children undergoing intensive chemotherapy remains limited. METHODS: KULT-SH was a phase III randomized crossover trial at two university hospitals in Northern Germany. Patients age 1-25 years with malignant diseases received either telemedicine follow-up visits (TV) or in-person outpatient follow-up visits (IPV) for 3 months, followed by crossover to the alternate mode. TV included video visits and electronic transmission of vital signs. The primary end point, evaluated in the intention-to-treat population, was the cumulative number of severe adverse events (Common Terminology Criteria for Adverse Events grade ≥3). For analysis, data from both crossover sequences were combined for the TV and IPV phases. RESULTS: Between June 2021 and May 2024, 55 patients (mean age 8.7 ± 6.0 years; 58% male) were randomly assigned. Overall, 18% of outpatient visits were delivered via telemedicine. 337 hospital visits were avoided, corresponding to 42,288 km of travel. Mean cumulative Common Terminology Criteria for Adverse Events scores were similar between phases (TV 4.09 ± 4.26 v IPV 4.00 ± 3.95; mean difference -0.05, 95% CI, -1.51 to 1.41; P = .949), indicating comparable rates of adverse events between TV and IPV. The most frequent grade 3-4 events were febrile neutropenia and gastrointestinal complications; no deaths occurred. Symptom-to-antibiotic time did not differ significantly between groups. CONCLUSION: Telemedicine follow-up visits represent a feasible alternative to in-person outpatient care during intensive chemotherapy, reducing travel burden without evidence of increased adverse events.