Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06940505

Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Head and Neck Cancers Behavior Head and Neck Neoplasms Health Behavior Laryngeal Carcinoma Laryngeal Diseases Laryngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Patient Satisfaction Respiratory Tract Diseases Respiratory Tract Neoplasms Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713GZ, Netherlands

Location status: Recruiting

Location contact

Nathalie F van Rhee, MD

CONTACT

[email protected]

+31614915058

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Patient satisfaction

    Time frame: 12 months

    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.

  2. Patient satisfaction

    Time frame: 12 months

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

  3. Local and regional recurrence rate

    Time frame: 12 months

    Safety is measured by addressing local and regional recurrence rate

  4. Postoperative complications after recurrence

    Time frame: 12 months

    Safety: postoperative complications after recurrence

  5. Re-referral to the head and neck oncology center

    Time frame: 12 months

    Safety: re-referral rates to the oncology center

  6. Disease specific and overall survival

    Time frame: 12 months

    Safety: survival

Other outcomes

  1. HRQoL

    Time frame: 12 months

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

  2. Symptom burden

    Time frame: 12 months

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

  3. Fear of disease recurrence

    Time frame: 12 months

    Using the Cancer Worry scale

  4. Traveling time and distance

    Time frame: 12 months

    Travel time in hours and minutes, distance in kilometres

  5. Number of visits to the hospital

    Time frame: 12 months

    Amount of hospital visits

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie F van Rhee, MD

CONTACT

[email protected]

+31614915058

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • Isala
  • Saxenburgh Group

Registry information

Official study title

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

Acronym: Telemedicine

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2025
Registry last updated
Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.