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

NCT06940505 | Recruiting

• 1 other identifier: M23.325004
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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 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

Conditions

Head and Neck Cancers; Laryngeal Carcinoma

Keywords

head and neck cancer; follow-up; patient satisfaction; telemedicine; patient reported outcome measures; quality of life

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• HRQoL

  12 months

• Symptom burden

  12 months

• Fear of disease recurrence

  12 months

Study Arms (2)

Telemedicine Group - Intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Telemedicine Follow-up OTHER

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

Telemedicine Group - Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Isala: collaborator
• Saxenburgh Group: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Laryngeal Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Otorhinolaryngologic Neoplasms; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Otorhinolaryngologic Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Boudewijn E.C. Plaat, MD, PhD

  UMC Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie F van Rhee, MD

CONTACT

+31614915058; n.f.van.rhee@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)