Recruiting
PRONTO-HN

Proactive Care Coordination for Head and Neck Cancer Surgery

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What is being tested

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

Other
Who is being recruted

Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer

+ Head &Amp;Amp; Neck Squamous Cell Carcinoma
+ Larynx Squamous Cell Carcinoma
Over 18 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Services Research Study

Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Study ContactApostolos Christopoulos, MD, MSc
Last updated: September 18, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 21, 2025Actual date on which the first participant was enrolled.

This study focuses on improving the timing of post-surgery treatments for head and neck cancer patients. Often, there are delays in starting radiotherapy after surgery, which can lead to worse health outcomes. The study is exploring whether a new system called PRONTO-HN can help keep these delays to a minimum, ideally under 42 days, at a specific hospital in Montreal. The system sends automated alerts and coordinates tasks among different healthcare providers to ensure timely treatment. By improving the process, the study aims to enhance survival rates and overall outcomes for patients undergoing postoperative care for head and neck cancer. Participants in this study are divided into two groups. The first group includes patients who received care before the new system was implemented, while the second group includes those treated with the new coordination system. The intervention involves automated alerts and risk assessments to help prioritize and coordinate care more efficiently. The study collects data on each patient's demographics and medical history without requiring their consent, as the intervention is administrative. Researchers will analyze the effectiveness of the system by looking at how well it reduces treatment delays and improves patient outcomes. A smaller group of patients is being studied to see if the new system can significantly reduce the number of patients experiencing delays longer than 42 days.

Official TitleProactive 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 
Principal SponsorCentre hospitalier de l'Université de Montréal (CHUM)
Study ContactApostolos Christopoulos, MD, MSc
Last updated: September 18, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
85 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Services Research Study
These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive treatments one after another in a pre-planned sequence. The next treatment may depend on how the participant responds to the previous one.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer
Head &Amp;Amp; Neck Squamous Cell Carcinoma
Larynx Squamous Cell Carcinoma
Criteria
6 inclusion criteria required to participate
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

Show More Criteria

2 exclusion criteria prevent from participating
Patients who do not end up receiving surgery
S-PORT > 180 days

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
No Intervention
Pre-implementation of care coordination system.
Group II
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.
Study Objectives
Primary Objectives

Number of days between surgery and start of radiotherapy (adjuvant)
Secondary Objectives

Event: Death (of any cause) Censor: Alive at last follow-up

Event: Locoregional recurrence (primary site or cervical node) or death Censored: Alive and without locoregional recurrence at last follow-up

Event: Distant metastasis or death Censored: Alive and without distant metastasis at last follow-up

Event: Any recurrence (local, regional, or distant) Censored: Recurrence-free at last follow-up. Death without recurrence also censored.

Event: Recurrence (any site) or death Censored: Alive and disease-free at last follow-up

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Centre Hospitalier de l'Université de MontréalMontreal, CanadaSee the location
Recruiting
One Study Center