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

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

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancers; Laryngeal Carcinoma
• Intervention / Treatment: Other: Telemedicine Follow-up

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nathalie F van Rhee, MD; Phone Number: +31614915058; Email: n.f.van.rhee@umcg.nl

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Nathalie F van Rhee, MD; Phone Number: +31614915058; Email: n.f.van.rhee@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine Group - Intervention; Participants in the intervention group will receive follow-up care at a general hospital located nearby their residence. They will have a travel time reduction of ≥ 40%. During these visits, a general otolaryngologist will perform guideline-based follow-up evaluations, including high-definition laryngoscopy. The recorded endoscopic videos will be securely transferred and remotely evaluated by specialists at the Head and Neck Oncology Centre (HNOC) via Telemedicine. This collaborative model allows for specialist oversight without requiring the patient to travel long distances, aiming to maintain high standards of care while improving accessibility and convenience.	Other: 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
No Intervention: Control group; Participants in the control group (standard of care) will receive their follow-up care directly at the Head and Neck Oncology Centre (HNOC), in accordance with national guidelines. Follow-up visits will include in-person evaluations by a specialized head and neck oncologist, including high-definition laryngoscopy performed and interpreted on-site. This group represents the current standard practice for follow-up care in the Netherlands and serves as the control (long travel time) for evaluating patient satisfaction and safety in comparison to the Telemedicine model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months
Patient satisfaction	Specific questions from the Consumer Quality Index (CQI) questionnaires are used for assessing patient satisfaction	12 months
Local and regional recurrence rate	Safety is measured by addressing local and regional recurrence rate	12 months
Postoperative complications after recurrence	Safety: postoperative complications after recurrence	12 months
Re-referral to the head and neck oncology center	Safety: re-referral rates to the oncology center	12 months
Disease specific and overall survival	Safety: survival	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HRQoL	In addition, the following outcome measures will be assessed: health related quality-of-life (HRQoL) using the ED-5D-5L questionnaire	12 months
Symptom burden	Using specific questions from the EORTC QLQ - H&N35 questionnaire	12 months
Fear of disease recurrence	Using the Cancer Worry scale	12 months
Traveling time and distance	Travel time in hours and minutes, distance in kilometres	12 months
Number of visits to the hospital	Amount of hospital visits	12 months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: Isala; Saxenburgh Group
• Investigators: Principal Investigator: Boudewijn E.C. Plaat, MD, PhD, UMC Groningen

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: April 7, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 23, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: quality of life; follow-up; telemedicine; head and neck cancer; patient reported outcome measures; patient satisfaction
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: M23.325004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participants will not provide explicit consent for their data to be shared beyond the scope of the current study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No