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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Telemedicine Follow-up

    Other intervention

    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

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Telemedicine Group - InterventionExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

Patient satisfaction

Specific questions from the Consumer Quality Index (CQI) questionnaires are used for assessing patient satisfaction

Time frame
12 months
3

Local and regional recurrence rate

Safety is measured by addressing local and regional recurrence rate

Time frame
12 months
4

Postoperative complications after recurrence

Safety: postoperative complications after recurrence

Time frame
12 months

Secondary outcomes

Other outcomes

1

HRQoL

In addition, the following outcome measures will be assessed: health related quality-of-life (HRQoL) using the ED-5D-5L questionnaire

Time frame
12 months
2

Symptom burden

Using specific questions from the EORTC QLQ - H\&N35 questionnaire

Time frame
12 months
3

Fear of disease recurrence

Using the Cancer Worry scale

Time frame
12 months
4

Traveling time and distance

Travel time in hours and minutes, distance in kilometres

Time frame
12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Isala

Collaborator

Saxenburgh Group

Collaborator