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

NCT07180901 | Recruiting

• 1 other identifier: DSP-21047
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief 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

Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer; Head &Amp;Amp; Neck Squamous Cell Carcinoma; Larynx Squamous Cell Carcinoma

Keywords

Surgery to post-operative radiation therapy interval; Treatment delays; Oral cavity cancer

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Overall survival

  From date of surgery until the date of date from any cause (assessed up to 60 months)

• Locoregional Survival

  From date of surgery until the date of locoregional recurrence or death, whichever came first (assessed up to 60 months)

• Distant metastasis-free survival

  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

  From date of surgery until the date of locoregional recurrence or distant metastasis, whichever came first (assessed up to 60 months)

• Disease-Free Survival

  From date of surgery until the date of locoregional recurrence or distant metastasis or death, whichever came first (assessed up to 60 months)

Study Arms (2)

Group A

NO INTERVENTION

Pre-implementation of care coordination system.

Group B

EXPERIMENTAL

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.

Other: Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO)

Interventions

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.

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Related Publications (3)

• 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.

  PMID: 40146171 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.

  PMID: 37948896 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.

  PMID: 37422839 BACKGROUND

MeSH Terms

Conditions

Mouth Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Therapeutics; Treatment Outcome; RID

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Prognosis; Diagnosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation

Study Officials

• Houda Bahig, MD PhD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Apostolos Christopoulos, MD, MSc

CONTACT

‭+1 (514) 625-7360‬; a.christopoulos@umontreal.ca

Gabriel S Dayan, MD

CONTACT

5147782303; gabriel.dayan@umontreal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A quasi-experimental, interrupted time-series. Group A will be pre-intervention and group B is post-intervention.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: September 18, 2025
• Study Start: August 21, 2025
• Primary Completion (Estimated): October 21, 2026
• Study Completion (Estimated): October 21, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)