Acta oncologica (Stockholm, Sweden) · 2025
Telemedicine follow-up for pre-malignant and malignant glottic lesions: a randomised controlled trial study protocol comparing care close to home versus standard of care.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Van Rhee Nathalie F, Schoonbeek Rosanne C, Wegner Inge, Vermeulen Karin M, Maat Robert C, Dietz de Loos Dirk A, Halmos György B, Plaat Boudewijn E C
Аннотация
BACKGROUND AND PURPOSE: In the Netherlands, care for head and neck cancer (HNC) is centralised in head and neck oncology centres (HNOCs). Follow-up after treatment requires frequent visits that can burden patients and providers. Telemedicine, through remote evaluation of laryngopharyngoscopy videos recorded at local hospitals, may offer a feasible alternative. This study protocol describes the aim to assess patient satisfaction and safety with telemedicine follow-up after treatment of (pre-)malignant glottic lesions, including severe dysplasia, carcinoma-in-situ and T1 squamous cell carcinoma, conducted at one HNOC and participating general hospitals.
METHODS AND ANALYSIS: As a non-blinded, randomised controlled trial, 90 patients with a one-way travel time by car of over 45 min to the HNOC will be allocated to the intervention group (follow-up by an Ear, Nose and Throat surgeon at a nearby participating hospital) or the control group (standard follow-up at the HNOC). All patients undergo guideline-based care. In the intervention group, laryngopharyngoscopy recordings will be remotely reviewed by HNOC specialists on the same day. Surveys will be fulfilled at baseline, 6 and 12 months. The primary outcome is overall patient satisfaction using a 0-10 numeric rating scale at 12 months follow-up. Secondary outcomes are safety, quality of life, fear of recurrence, travel time and carbon-dioxide emission. Safety will be assessed through recurrence, complications, re-referral and survival. Between-group and within-group comparisons will be performed to evaluate differences in outcomes, using appropriate statistical methods based on data distribution.
ETHICS AND DISSEMINATION: This study explores regional collaboration and sustainable follow-up for HNC patients. The ethics board approved the protocol (M23.325004). The authors commit to publishing the findings.
METHODS AND ANALYSIS: As a non-blinded, randomised controlled trial, 90 patients with a one-way travel time by car of over 45 min to the HNOC will be allocated to the intervention group (follow-up by an Ear, Nose and Throat surgeon at a nearby participating hospital) or the control group (standard follow-up at the HNOC). All patients undergo guideline-based care. In the intervention group, laryngopharyngoscopy recordings will be remotely reviewed by HNOC specialists on the same day. Surveys will be fulfilled at baseline, 6 and 12 months. The primary outcome is overall patient satisfaction using a 0-10 numeric rating scale at 12 months follow-up. Secondary outcomes are safety, quality of life, fear of recurrence, travel time and carbon-dioxide emission. Safety will be assessed through recurrence, complications, re-referral and survival. Between-group and within-group comparisons will be performed to evaluate differences in outcomes, using appropriate statistical methods based on data distribution.
ETHICS AND DISSEMINATION: This study explores regional collaboration and sustainable follow-up for HNC patients. The ethics board approved the protocol (M23.325004). The authors commit to publishing the findings.