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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Telemedicine Follow-up
Other interventionOncological 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
Treatment groups
Trial outcomes
Primary outcomes
Patient satisfaction
Our primary outcomes are satisfaction with care and travel distance. Satisfaction is reported on a 0-10 numerical rating scale (NRS) and will be compared between study groups at baseline and 6 months and 12 months post-inclusion.
Patient satisfaction
Specific questions from the Consumer Quality Index (CQI) questionnaires are used for assessing patient satisfaction
Local and regional recurrence rate
Safety is measured by addressing local and regional recurrence rate
Postoperative complications after recurrence
Safety: postoperative complications after recurrence
Other outcomes
HRQoL
In addition, the following outcome measures will be assessed: health related quality-of-life (HRQoL) using the ED-5D-5L questionnaire
Symptom burden
Using specific questions from the EORTC QLQ - H\&N35 questionnaire
Fear of disease recurrence
Using the Cancer Worry scale
Traveling time and distance
Travel time in hours and minutes, distance in kilometres
Sponsors and contacts
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