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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Telemedicine Follow-up

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University Medical Center Groningen

Lead sponsor

Isala

Collaborator

Saxenburgh Group

Collaborator