Cancer of Head and NeckSTOP-HNCNCT06995417
Discontinuation of Tobacco Dependence in Smoking Patients With Squamous Cell Carcinoma of the Head-neck District: Multicenter Prospective Observational Study
An observational study of Cancer of Head and Neck, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Head and Neck
- What is being tested?
- Smoking counseling
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2025to May 2030
- Phase
- Observational
- 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
Study population: The study population will be patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental examinations) that led to the cancer diagnosis
Who may be able to join
- Patients with SCCHN tumors of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, and paranasal sinuses.
- Patients older than 18 years of age with SCCHN of these sites who are candidates for surgical/radiotherapy (RT)/radiochemotherapy (RTCT) treatment with curative intent (primary treatment).
- Patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental tests) that led to the diagnosis of cancer
Who cannot join
- Patients with SCCHN cancer who have quit smoking for more than 30 days at the time of initiation of the diagnostic process.
- Patients using only e-cigarettes at the time of initiation of the treatment process.
- Patients with non-SCCHN cancer in recurrent metastatic stage and not eligible for curative purpose therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Azienda Ospedaliera Careggi
Florence, Firenze, 51134
LORENZO LIVI, +390557947019, lorenzo.livi@unifi.it
Pierluigi Bonomo, MEDICAL DOCTOR
About this study
The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.
- Conditions
- Cancer of Head and Neck
- Being tested
- Smoking counseling
- Keywords
- Cancer Head&Neck, Smoker
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking counselingOther
The investigator, upon enrollment, will initiate a standardized strategy from clinical practice: the investigator will conduct brief counseling ("minimal advice") using the administration of of a questionnaire that will include, in addition to questions about current and past, the administration of the Fagerstrom test to measure physical dependence on nicotine and questions to investigate intention to quit smoking (Mondor test)
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of a standardized counseling strategy in clinical practice to promote smoking cessation
The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.
Measured: 6+1 months from enrollment, i.e., initiation of anti-smoking counseling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Head and NeckStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorenzo Livi, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- LORENZO LL LIVI, MEDICAL DOCTOR, Principal investigator, AOU Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995417
- Sponsor's protocol ID
- STOP-HNC
- Acronym
- STOP-HNC
- Status last verified
- May 2025
- First submitted
- 31 Mar 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discontinuation of Tobacco Dependence in Smoking Patients With Squamous Cell Carcinoma of the Head-neck District: Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06995417
- Acronym / sponsor ID
- STOP-HNC / STOP-HNC
- Conditions
- Cancer of Head and Neck
- Keywords
- Cancer Head&Neck, Smoker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 29 May 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.
The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental examinations) that led to the cancer diagnosis
Key inclusion criteria (3 listed)
- Patients with SCCHN tumors of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, and paranasal sinuses.
- Patients older than 18 years of age with SCCHN of these sites who are candidates for surgical/radiotherapy (RT)/radiochemotherapy (RTCT) treatment with curative intent (primary treatment).
- Patients with SCCHN who are active smokers, or have quit smoking for less than 30 days, at the time of initiation of the process (visits and instrumental tests) that led to the diagnosis of cancer
Key exclusion criteria (3 listed)
- Patients with SCCHN cancer who have quit smoking for more than 30 days at the time of initiation of the diagnostic process.
- Patients using only e-cigarettes at the time of initiation of the treatment process.
- Patients with non-SCCHN cancer in recurrent metastatic stage and not eligible for curative purpose therapy.
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 |
|---|---|---|
| Smoking counselingThe investigator, upon enrollment, will initiate a standardized strategy from clinical practice: the investigator will conduct brief counseling ("minimal advice") using the administration of of a questionnaire that will include, in addition to questions about current and past, the administration of the Fagerstrom test to measure physical dependence on nicotine and questions to investigate intention to quit smoking (Mondor test) | Other | – |
Primary outcome
Effectiveness of a standardized counseling strategy in clinical practice to promote smoking cessation
Time frame: 6+1 months from enrollment, i.e., initiation of anti-smoking counseling.
The primary objective of our study is to evaluate the effectiveness of a standardized clinical practice counseling strategy for promoting post-diagnosis smoking cessation among patients with SCCHN. Efficacy will be measured as the percentage of patients who succeed in sustained smoking cessation ("sustained quitters," see below) at 6+1 months after enrollment, i.e., after the initiation of anti-smoking counseling.
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 29 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
LORENZO LL LIVI, MEDICAL DOCTOR principal investigator
AOU Careggi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of Head and Neck, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 May 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 Italy. 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 PIERLUIGI PB BONOMO, MEDICAL DOCTOR (+390557947010, bonomopierlu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of a standardized counseling strategy in clinical practice to promote smoking cessation (time frame: 6+1 months from enrollment, i.e., initiation of anti-smoking counseling.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.