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.
Nathalie F Van Rhee, Rosanne C Schoonbeek, Inge Wegner, Karin M Vermeulen, Robert C Maat, Dirk A Dietz de Loos, György B Halmos, Boudewijn E C Plaat
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引用次数: 0
Abstract
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.
期刊介绍：
Acta Oncologica is a journal for the clinical oncologist and accepts articles within all fields of clinical cancer research. Articles on tumour pathology, experimental oncology, radiobiology, cancer epidemiology and medical radio physics are also welcome, especially if they have a clinical aim or interest. Scientific articles on cancer nursing and psychological or social aspects of cancer are also welcomed. Extensive material may be published as Supplements, for which special conditions apply.
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