Proactive Risk-based Optimization & Notifications for Treatment & Outcomes in Head & Neck Cancer
NCT ID: NCT07180901
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
85 participants
INTERVENTIONAL
2025-08-21
2029-10-21
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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Group A
Pre-implementation of care coordination system.
No interventions assigned to this group
Group B
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* S-PORT \> 180 days
18 Years
ALL
No
Sponsors
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Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Responsible Party
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Principal Investigators
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Houda Bahig, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Centre hospitalier de l'Université de Montréal (CHUM)
Locations
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Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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DSP-21047
Identifier Type: -
Identifier Source: org_study_id
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