Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Standard of Care

Официальное название

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

Обзор

The goal of this clinical trial is to evaluate whether Telemedicine follow-up is a satisfactory and safe alternative to traditional follow-up care for patients treated for early glottic (vocal cord) cancer, particularly those who live far from a specialized head and neck oncology centre (HNOC). The main questions it aims to answer are: Is patient satisfaction with Telemedicine follow-up comparable to standard care? Is the safety of Telemedicine follow-up (measured by recurrence rates, complications, and survival) comparable to in-person follow-up at an HNOC? Researchers will compare patients receiving Telemedicine follow-up in a nearby hospital with standard in-person follow-up at the HNOC, to see if remote evaluation of endoscopic procedures can maintain patient satisfaction and safety outcomes. Participants with a travel time of \> 45 minutes from a HNOC will: Be randomly assigned to either a Telemedicine follow-up group (in a nearby hospital, by a general ENT-surgeon) or a standard of care group Undergo follow-up including HD-laryngoscopy, according to clinical guidelines Have endoscopy videos evaluated remotely by specialists at the HNOC (= Telemedicine) (intervention group only) Complete surveys including patient-reported outcomes and experience measures at baseline, 6 months, and 12 months

Вмешательства

• Другое Telemedicine Follow-up
  Oncological follow-up in a general hospital close to the patient, with aid of Telemedicine evaluation of the endoscopy video's by a Head and Neck surgeon in a specialised oncology centre

Первичные конечные точки

• Patient satisfaction [Срок оценки: 12 months]
• Patient satisfaction [Срок оценки: 12 months]
• Local and regional recurrence rate [Срок оценки: 12 months]
• Postoperative complications after recurrence [Срок оценки: 12 months]
• Re-referral to the head and neck oncology center [Срок оценки: 12 months]
• Disease specific and overall survival [Срок оценки: 12 months]

Критерии участия

Критерии включения

• patients who underwent TOLS for early stage glottic squamous cell carcinoma (T1 or carcinoma-in-situ)
• a one-way travel time to the HNOC of ≥45 minutes (intervention group) or < 30 minutes (control group)
• within 2 years postoperatively
• can speak and write Dutch

Критерии исключения

• Patients will be excluded if they continue to undergo follow-up for other (head and neck) cancers in the HNOC.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Нидерланды · 1 центр

• University Medical Center Groningen — Groningen

Идентификаторы

NCT: NCT06940505 · M23.325004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗