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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Disease specific and overall survival
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients will be excluded if they continue to undergo follow-up for other (head and neck) cancers in the HNOC.
研究组 & 干预措施
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.
干预措施: 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.
结局指标
主要结局
Disease specific and overall survival
时间窗: 12 months
Safety: survival
Patient satisfaction
时间窗: 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
时间窗: 12 months
Safety is measured by addressing local and regional recurrence rate
Postoperative complications after recurrence
时间窗: 12 months
Safety: postoperative complications after recurrence
Re-referral to the head and neck oncology center
时间窗: 12 months
Safety: re-referral rates to the oncology center
次要结局
未报告次要终点