Clinical trial NCT06940505: Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Comparing Care Close to Home Versus Standard of Care
Official title: Telemedicine Follow-Up for Early Laryngeal Cancer: a Randomized Controlled Trial Study Protocol Comparing Care Close to Home Versus Standard of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancers
Laryngeal Carcinoma
Keywords: head and neck cancer
follow-up
patient satisfaction
telemedicine
patient reported outcome measures
quality of life
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Isala
name: Saxenburgh Group
First posted: 2025-04-23
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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


Eligibility criteria: 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.

Primary outcomes:
measure: Patient satisfaction
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 12 months
measure: Local and regional recurrence rate
timeFrame: 12 months
measure: Postoperative complications after recurrence
timeFrame: 12 months
measure: Re-referral to the head and neck oncology center
timeFrame: 12 months
measure: Disease specific and overall survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
measure: HRQoL
timeFrame: 12 months
measure: Symptom burden
timeFrame: 12 months
measure: Fear of disease recurrence
timeFrame: 12 months
measure: Traveling time and distance
timeFrame: 12 months
measure: Number of visits to the hospital
timeFrame: 12 months
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMC Groningen
name: Boudewijn E.C. Plaat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: