Proactive Risk-based Optimization & Notifications for Treatment & Outcomes (PRONTO) in Head & Neck Cancer: A Strategy to Reduce Delays From Surgery to Post-Operative Adjuvant Therapy in Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Surgery to post-operative radiotherapy time (S-PORT)
研究概览
简要总结
Delays between surgery and the initiation of post-operative radiotherapy (S-PORT) in head and neck cancer (HNC) patients are prevalent and associated with worse oncologic outcomes. This pilot study evaluates whether a proactive, automated care coordination system (PRONTO-HN) can improve adherence to recommended S-PORT intervals of ≤42 days at the Centre hospitalier de l'Université de Montréal (CHUM).
The study is a single-center, quasi-experimental, interrupted time-series design with two phases. Group A (control) includes patients treated before the intervention (using a prospectively maintained database from August 2024 to August 2025). Group B (intervention) includes patients treated with the new coordination system from September 2025 to September 2026.
The intervention includes automated alerts, multidisciplinary task coordination, and risk stratification based on a predictive model developed and published by our team. This model uses only pre-operative data to estimate the likelihood that a patient will require adjuvant therapy after surgery, stratifying patients into high- and low-risk categories. High-risk patients receive intensified coordination protocols, including early oncology and dental consultations and shorter target times for pathology results.
Primary objective: Reduce the proportion of patients with S-PORT > 42 days. Secondary/tertiary objectives: Reduce mean S-PORT time. Evaluate impacts on overall, locoregional, and disease-free survival in a 2- and 3-year follow up study.
Patients are identified at the time the operating room request is submitted. Demographic, clinical, and oncologic data are collected and stored securely in REDCap. As the intervention is administrative in nature and does not modify patient care, consent is waived.
Statistical analysis will evaluate the intervention's effect and identify predictors of delays. A sample of 38 patients per group provides adequate power to detect a drop in S-PORT > 42 days from 80% to 50%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •All adult patients (age 18 or older).
- •Pathologically confirmed oral cavity or laryngeal squamous cell carcinoma.
- •Diagnosed from July 2024 to September
- •With planned primary intention surgical resection.
- •With or without adjuvant therapy.
- •Treated at the Centre Hospitalier de l'Université de Montréal.
排除标准
- •Patients who do not end up receiving surgery.
- •S-PORT > 180 days
研究组 & 干预措施
Group A
Pre-implementation of care coordination system.
Group B
Post-implementation of PRONTO-HN system:
- Pre-operative risk stratification of requiring adjuvant therapy using our predictive model, applied at tumor board. Patients stratified as fast-track vs normal-track.
- High-risk patients receive intensive preoperative and postoperative coordination. Low-risk patients are monitored but escalated rapidly if adverse pathology is detected. This includes:
- pre-operative dental consultation for fast-track
- pre-operative oncology consultation for fast-track with high-risk features
- target pathology results 14 days post-operatively for fast-track
- Automated reminders and target dates sent to members of the multidisciplinary team.
干预措施: Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO) (Other)
结局指标
主要结局
Surgery to post-operative radiotherapy time (S-PORT)
时间窗: Day 1 of radiotherapy (assessed up to 12 weeks post-operatively)
Number of days between surgery and start of radiotherapy (adjuvant)
次要结局
- Overall survival(From date of surgery until the date of date from any cause (assessed up to 60 months))
- Locoregional Survival(From date of surgery until the date of locoregional recurrence or death, whichever came first (assessed up to 60 months))
- Distant metastasis-free survival(The time from surgery to event. From date of surgery until the date of distant metastasis or death, whichever came first (assessed up to 60 months))
- Recurrence-Free Survival(From date of surgery until the date of locoregional recurrence or distant metastasis, whichever came first (assessed up to 60 months))
- Disease-Free Survival(From date of surgery until the date of locoregional recurrence or distant metastasis or death, whichever came first (assessed up to 60 months))