RecruitingNot ApplicableNCT07180901

Proactive Risk-based Optimization & Notifications for Treatment & Outcomes in Head & Neck Cancer

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


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

85 participants

Start Date

Aug 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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%.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is following adults being treated for mouth (oral cavity) or voice box (laryngeal) squamous cell cancer at a Montreal hospital. It monitors risks during treatment and recovery using a tool that flags potential complications early, aiming to improve care coordination. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell cancer of the mouth or larynx (voice box) - You were diagnosed between July 2024 and September 2026 - You are planning to have surgery as the primary treatment, with or without additional therapy - You are being treated at the Centre Hospitalier de l'Université de Montréal **You may NOT be eligible if...** - You ultimately do not receive surgery - Significant delays occur before starting your treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERProactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO)

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.


Locations(1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

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NCT07180901


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