PRONTO System for Mouth and Throat Cancer

(PRONTO-HN Trial)

Overseen By Gabriel S Dayan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: No surgery, S-PORT > 180 days

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

85 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO) system can expedite the start of post-surgery radiation treatment for patients with mouth and throat cancer. Delays in starting this treatment can worsen health outcomes, so the trial tests an automated coordination system to maintain timely care. The system provides alerts and organizes tasks to ensure patients receive prompt treatment. Eligible participants should have a confirmed diagnosis of mouth or throat cancer and plan to undergo surgery at the Centre Hospitalier de l'Université de Montréal. As an unphased trial, this study offers the chance to contribute to innovative solutions that could improve treatment timelines for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on improving care coordination after surgery, so it's best to discuss your medications with the trial team.

What prior data suggests that the PRONTO system is safe for improving care coordination in head and neck cancer patients?

Research shows that systems like the PRONTO system improve the timing of treatments for patients with head and neck cancer. These systems enhance patient care efficiency without altering the medical treatment itself.

Studies of similar systems have reported no safety issues with automated alerts and coordination tools. These systems focus on better scheduling and communication, not on medical procedures or drugs, making them generally safe and well-tolerated.

The PRONTO system organizes tasks and sends reminders to healthcare teams to maintain treatment schedules. It does not involve direct medical treatment, so it poses no additional risk to patients. This system improves care delivery, ensuring timely treatment, which is crucial for better health outcomes.

The main goal is to reduce treatment delays, potentially leading to better survival rates for patients. As an administrative tool, the system is considered safe for managing patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRONTO System for mouth and throat cancer because it introduces a novel approach to care coordination. Unlike traditional methods that often follow a one-size-fits-all model, PRONTO uses a predictive model for risk stratification, allowing for more personalized treatment plans. High-risk patients receive intensive coordination before and after surgery, which can lead to faster intervention if needed. Automated reminders and target dates ensure that the multidisciplinary team stays on the same page, aiming to improve patient outcomes with more efficient and responsive care.

What evidence suggests that the PRONTO system is effective for improving S-PORT intervals in head and neck cancer patients?

Research has shown that starting radiotherapy late after surgery can worsen outcomes for head and neck cancer patients. In this trial, the PRONTO system, used in Group B, prevents delays by sending automatic alerts and enhancing care coordination. Studies have found that better coordination keeps treatment on schedule. The system uses a predictive model to identify high- or low-risk patients, ensuring prompt attention for those who need it. This approach aims to reduce treatment delays and potentially improve survival rates. ^{1 3 6 7 8}

Who Is on the Research Team?

Houda Bahig, MD PhD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Are You a Good Fit for This Trial?

This trial is for patients with head and neck cancers, such as oral neoplasm, mouth cancer, throat cancer, or laryngeal squamous cell carcinoma. They must be scheduled for surgery followed by post-operative radiotherapy at CHUM.

Inclusion Criteria

I am 18 years old or older.

Diagnosed from July 2024 to September 2026

Treated at the Centre Hospitalier de l'Université de Montréal

Exclusion Criteria

I will not undergo surgery for my condition.

S-PORT > 180 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Coordination

Pre-operative risk stratification and consultations for high-risk patients

Up to 14 days

Multiple consultations (oncology, dental)

Post-operative Coordination

Automated alerts and multidisciplinary task coordination to ensure timely S-PORT

Up to 12 weeks

Follow-up

Participants are monitored for survival outcomes and recurrence

60 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The PRONTO-HN system is being tested to see if it can ensure patients start their post-surgery radiotherapy within 42 days. It involves automated alerts and task coordination based on risk levels determined before surgery.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

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 II: Group A Active Control 1 Intervention

Pre-implementation of care coordination system.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Citations

1. patlynk.com patlynk.com/trial/NCT07180901

Proactive Care Coordination for Head and Neck Cancer ... This study focuses on improving the timing of post-surgery treatments for head and neck cancer patients. Often, there are delays in starting radiotherapy ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S277290602400517X

Review Article Oral oncology quality risk management This review explores the essential principles of QRM as they relate to oral oncology, focusing on the importance of patient safety and treatment effectiveness.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12385764/

Targeted Screening Strategies for Head and Neck Cancer For instance, in oral cavity cancer, early-stage tumors give an 80% 3-year survival rate, whereas late-stage disease shows only 50% survival at 3 years [8].

4. faculty.mdanderson.org faculty.mdanderson.org/profiles/katherine_hutcheson.html

Katherine A. Hutcheson, Ph.D. The mission of her research is to optimize functional outcomes and quality of life in head and neck cancer survivorship. She directs a line of practice-oriented ...

5. icr.ac.uk icr.ac.uk/research-and-discoveries/find-a-researcher/test-researcher-profile-detail/professor-kevin-harrington

Professor Kevin Harrington Professor Harrington specialises in developing new treatments using biologically-targeted agents (such as viruses, antibodies and small molecules)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11825061/

Optimization of alert notifications in electronic patient-reported ... We developed an algorithm for suppressing alerts based on patient assessment of urgency and model-based predictions of nurse assessment of urgency.

7. theproteusconsortium.org theproteusconsortium.org/wp-content/uploads/2025/06/Optimization-of-Alert-Notifications.pdf

Optimization of alert notifications in electronic patient- ... PRO-TECT (Alliance AFT-39) was a U.S. national trial evaluating ePRO remote symptom monitoring versus usual care in patients receiving metastatic cancer ...

8. mdpi.com mdpi.com/2075-4418/15/3/280

Artificial Intelligence in Oral Cancer: A Comprehensive ... AI may transform oral cancer diagnosis and treatment. It can develop early detection, risk modelling, imaging phenotypic change, and prognosis.