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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%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | No Intervention | Pre-implementation of care coordination system. | |
| Group B | Experimental | Post-implementation of PRONTO-HN system:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery to post-operative radiotherapy time (S-PORT) | Number of days between surgery and start of radiotherapy (adjuvant) | Day 1 of radiotherapy (assessed up to 12 weeks post-operatively) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Event: Death (of any cause) Censor: Alive at last follow-up | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Apostolos Christopoulos, MD, MSc | Contact | +1 (514) 625-7360 | a.christopoulos@umontreal.ca | |
| Gabriel S Dayan, MD | Contact | 5147782303 | gabriel.dayan@umontreal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Houda Bahig, MD PhD | Centre hospitalier de l'Université de Montréal (CHUM) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de l'Université de Montréal | Recruiting | Montreal | Quebec | H2X 0C1 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40146171 | Background | 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 Head Neck Surg. 2025 May 1;151(5):466-475. doi: 10.1001/jamaoto.2024.5250. | |
| 37948896 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 25, 2025 |
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A quasi-experimental, interrupted time-series. Group A will be pre-intervention and group B is post-intervention.
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|
| 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 | 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. | 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 | From date of surgery until the date of locoregional recurrence or distant metastasis or death, whichever came first (assessed up to 60 months) |
| Background |
| 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. |
| 37422839 | Background | 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 Otolaryngol Head Neck Surg. 2023 Nov 1;149(11):961-969. doi: 10.1001/jamaoto.2023.1936. |
| Aug 20, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D009062 | Mouth Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016896 | Treatment Outcome |
| C027982 | RID |
| ID | Term |
|---|---|
| D011379 | Prognosis |
| D003933 | Diagnosis |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D017530 | Health Care Quality, Access, and Evaluation |
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