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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Disease specific and overall survival
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Telemedicine Follow-up (Other)
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.
Outcomes
Primary Outcomes
Disease specific and overall survival
Time Frame: 12 months
Safety: survival
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.
Local and regional recurrence rate
Time Frame: 12 months
Safety is measured by addressing local and regional recurrence rate
Postoperative complications after recurrence
Time Frame: 12 months
Safety: postoperative complications after recurrence
Re-referral to the head and neck oncology center
Time Frame: 12 months
Safety: re-referral rates to the oncology center
Secondary Outcomes
No secondary outcomes reported