Trials / Recruiting

RecruitingNCT07180901

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 85 (estimated)

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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%.

Conditions

Interventions

Type	Name	Description
OTHER	Proactive 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.

Timeline

Start date: 2025-08-21
Primary completion: 2026-10-21
Completion: 2029-10-21
First posted: 2025-09-18
Last updated: 2025-09-18

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT07180901. Inclusion in this directory is not an endorsement.