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

Authors

  • Nathalie F. van Rhee Department of Otorhinolaryngology - Head and Neck Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands; Graduate School of Medical Sciences, University of Groningen, Groningen, The Netherlands https://orcid.org/0009-0009-0457-9439
  • Rosanne C. Schoonbeek Department of Otorhinolaryngology - Head and Neck Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands https://orcid.org/0000-0002-3103-943X
  • Inge Wegner Department of Otorhinolaryngology - Head and Neck Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands https://orcid.org/0000-0002-4124-7224
  • Karin M. Vermeulen Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands https://orcid.org/0000-0001-9257-2791
  • Robert C. Maat Department of Otorhinolaryngology, Saxenburgh Medical Center, Hardenberg, The Netherlands
  • Dirk A. Dietz de Loos Department of Otorhinolaryngology, Isala Hospital, Zwolle, The Netherlands
  • György B. Halmos Department of Otorhinolaryngology - Head and Neck Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands https://orcid.org/0000-0003-2460-2260
  • Boudewijn E.C. Plaat Department of Otorhinolaryngology - Head and Neck Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands https://orcid.org/0000-0001-8631-7727

DOI:

https://doi.org/10.2340/1651-226X.2025.43947

Keywords:

head and neck cancer, telemedicine, follow-up, patient reported outcome measures, quality of life, patient satisfaction, clinical trial protocol

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.

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2025-08-12

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van Rhee, N. F., Schoonbeek, R. C., Wegner, I., Vermeulen, K. M., Maat, R. C., Dietz de Loos, D. A., … Plaat, B. E. (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. Acta Oncologica, 64, 1035–1040. https://doi.org/10.2340/1651-226X.2025.43947

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Vol. 64 (2025): Acta Oncologica

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Short report

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Copyright (c) 2025 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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