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

Not Applicable

Recruiting

• Conditions: Head and Neck Cancers; Laryngeal Carcinoma

• Registration Number: NCT06940505
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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 will:

Be randomly assigned to either a Telemedicine follow-up group (if they live ≥ 45 minutes from an HNOC) 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04-01
• Study First Submitted: 2025-04-07
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-23
• Last Update Posted: 2025-04-23
• Primary Completion: 2027-04-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands