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%.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
85
Post-implementation of PRONTO-HN system: 1. Pre-operative risk stratification of requiring adjuvant therapy using our predictive model, applied at tumor board. Patients stratified as fast-track vs normal-track. 2. 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 3. Automated reminders and target dates sent to members of the multidisciplinary team.
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
RECRUITINGSurgery to post-operative radiotherapy time (S-PORT)
Number of days between surgery and start of radiotherapy (adjuvant)
Time frame: Day 1 of radiotherapy (assessed up to 12 weeks post-operatively)
Overall survival
Event: Death (of any cause) Censor: Alive at last follow-up
Time frame: From date of surgery until the date of date from any cause (assessed up to 60 months)
Locoregional Survival
Event: Locoregional recurrence (primary site or cervical node) or death Censored: Alive and without locoregional recurrence at last follow-up
Time frame: From date of surgery until the date of locoregional recurrence or death, whichever came first (assessed up to 60 months)
Distant metastasis-free survival
Event: Distant metastasis or death Censored: Alive and without distant metastasis at last follow-up
Time frame: 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
Event: Any recurrence (local, regional, or distant) Censored: Recurrence-free at last follow-up. Death without recurrence also censored.
Time frame: From date of surgery until the date of locoregional recurrence or distant metastasis, whichever came first (assessed up to 60 months)
Disease-Free Survival
Event: Recurrence (any site) or death Censored: Alive and disease-free at last follow-up
Time frame: From date of surgery until the date of locoregional recurrence or distant metastasis or death, whichever came first (assessed up to 60 months)
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