Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity CancerPRONTO-HNNCT07180901
Proactive Risk-based Optimization & Notifications for Treatment & Outcomes in Head & Neck Cancer
A study testing Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO) in people with Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer and Head &Amp;Amp; Neck Squamous Cell Carcinoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer, Head &Amp;Amp; Neck Squamous Cell Carcinoma, Larynx Squamous Cell Carcinoma
- What is being tested?
- Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteCanada
- Study dates
- 21 Aug 2025to 21 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients who do not end up receiving surgery.
- S-PORT > 180 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0C1
Apostolos Christopoulos, MD, MSc, 514-625-7360, a.christopoulos@umontreal.ca
Houda Bahig, MD, PhD, 514-690-8546, houda.bahig@umontreal.ca
About this study
Official title: Proactive 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
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.
Read more
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
- Being tested
- Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO)
- Keywords
- Surgery to post-operative radiation therapy interval, Treatment delays, Oral cavity cancer
- Medical subject headings
- Mouth Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery to post-operative radiotherapy time (S-PORT)
Number of days between surgery and start of radiotherapy (adjuvant)
Measured: Day 1 of radiotherapy (assessed up to 12 weeks post-operatively)
Secondary outcomes (5)
Overall survival
Event: Death (of any cause) Censor: Alive at last follow-up
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: From date of surgery until the date of locoregional recurrence or distant metastasis or death, whichever came first (assessed up to 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start21 Aug 2025
- Primary completion21 Oct 2026 (estimated)
- Study completion21 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A quasi-experimental, interrupted time-series. Group A will be pre-intervention and group B is post-intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Houda Bahig, MD PhD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180901
- Sponsor's protocol ID
- DSP-21047
- Acronym
- PRONTO-HN
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40146171Dayan 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.
PubMed 37948896Dayan 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.
PubMed 37422839
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive 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
- ClinicalTrials.gov ID
- NCT07180901
- Acronym / sponsor ID
- PRONTO-HN / DSP-21047
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 21 Oct 2026 (estimated)
- Study completion
- 21 Oct 2029 (estimated)
- First posted
- 18 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A quasi-experimental, interrupted time-series. Group A will be pre-intervention and group B is post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –Pre-implementation of care coordination system. |
| Group B | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients who do not end up receiving surgery.
- S-PORT > 180 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group B |
Primary outcome
Surgery to post-operative radiotherapy time (S-PORT)
Time frame: Day 1 of radiotherapy (assessed up to 12 weeks post-operatively)
Number of days between surgery and start of radiotherapy (adjuvant)
5 secondary outcomes
Overall survival
Time frame: From date of surgery until the date of date from any cause (assessed up to 60 months)
Locoregional Survival
Time frame: From date of surgery until the date of locoregional recurrence or death, whichever came first (assessed up to 60 months)
Distant metastasis-free survival
Time frame: 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
Time frame: From date of surgery until the date of locoregional recurrence or distant metastasis, whichever came first (assessed up to 60 months)
Disease-Free Survival
Time frame: From date of surgery until the date of locoregional recurrence or distant metastasis or death, whichever came first (assessed up to 60 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Background: PubMed 40146171Dayan 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.
- Background: PubMed 37948896Dayan 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.
- Background: PubMed 37422839Dayan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Houda Bahig, MD PhD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Risk-Based Optimization and Notifications for Treatment and Outcomes (PRONTO) in people with Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer and Head &Amp;Amp; Neck Squamous Cell Carcinoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Apostolos Christopoulos, MD, MSc (+1 (514) 625-7360, a.christopoulos@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgery to post-operative radiotherapy time (S-PORT) (time frame: Day 1 of radiotherapy (assessed up to 12 weeks post-operatively)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07180901, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.