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

Официальное название

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

Обзор

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%.

Вмешательства

• Другое 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-tra

Первичные конечные точки

• Surgery to post-operative radiotherapy time (S-PORT) [Срок оценки: Day 1 of radiotherapy (assessed up to 12 weeks post-operatively)]

Вторичные конечные точки (5)

• Overall survival [Срок оценки: From date of surgery until the date of date from any cause (assessed up to 60 months)]
• Locoregional Survival [Срок оценки: From date of surgery until the date of locoregional recurrence or death, whichever came first (assessed up to 60 months)]
• Distant metastasis-free survival [Срок оценки: 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 [Срок оценки: From date of surgery until the date of locoregional recurrence or distant metastasis, whichever came first (assessed up to 60 months)]
• Disease-Free Survival [Срок оценки: From date of surgery until the date of locoregional recurrence or distant metastasis or death, whichever came first (assessed up to 60 months)]

Критерии участия

Критерии включения

• All adult patients (age 18 or older).
• Pathologically confirmed oral cavity or laryngeal squamous cell carcinoma.
• Diagnosed from July 2024 to September 2026.
• With planned primary intention surgical resection.
• With or without adjuvant therapy.
• Treated at the Centre Hospitalier de l'Université de Montréal.

Критерии исключения

• Patients who do not end up receiving surgery.
• S-PORT > 180 days

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

Канада · 1 центр

• Centre Hospitalier de l'Université de Montréal — Montreal

Публикации

• Dayan GS, Bahig H, Colivas J, Eskander A, Johnson-Obaseki S, Chandarana S, de Almeida JR, Nichols AC, Hier M, Belzile M, Avagnina A, Hong X, Gaudet M, Matthews TW, Hart R, Goldstein DP, Hosni A, MacNeil D, Fowler J, Khalil C, Khoury M, Morand G, Sultanem K, Ayad T, Christopoulos A. Preoperative Clinical and Tumor Factors Associated With Adjuvant Therapy for Oral Cavity Cancer. JAMA Otolaryngol Hea PMID 40146171
• Dayan G, Bahig H, Fortin B, Filion E, Nguyen-Tan PF, O'Sullivan B, Charpentier D, Soulieres D, Gologan O, Nelson K, Letourneau L, Schmittbuhl M, Ayad T, Bissada E, Guertin L, Tabet P, Christopoulos A. Predictors of prolonged treatment time intervals in oral cavity cancer. Oral Oncol. 2023 Dec;147:106622. doi: 10.1016/j.oraloncology.2023.106622. Epub 2023 Nov 8. PMID 37948896
• Dayan GS, Bahig H, Johnson-Obaseki S, Eskander A, Hong X, Chandarana S, de Almeida JR, Nichols AC, Hier M, Belzile M, Gaudet M, Dort J, Matthews TW, Hart R, Goldstein DP, Yao CMKL, Hosni A, MacNeil D, Fowler J, Higgins K, Khalil C, Khoury M, Mlynarek AM, Morand G, Sultanem K, Maniakas A, Ayad T, Christopoulos A. Oncologic Significance of Therapeutic Delays in Patients With Oral Cavity Cancer. JAMA PMID 37422839

Идентификаторы

NCT: NCT07180901 · DSP-21047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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