Cigarette Smoking-Related CarcinomaNCT07857681
Text Message and Mail Delivery of Tailored Educational Materials to Improve Access to Resources for Smoking Cessation of Menthol Tobacco Cigarettes
A study testing Educational Intervention, Internet-Based Intervention and Smartphone Application-based Intervention in people with Cigarette Smoking-Related Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This clinical trial compares the impact of receiving educational materials containing relevant content about risks from smoking menthol cigarettes which include links to the New York (NY) Smoke-Free website by text message or mail in people who smoke menthol cigarettes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Educational Intervention, Internet-Based Intervention and Smartphone Application-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2025to 12 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Residents of New York State
- English Speaking
- Willingness to receive and engage with mailed educational materials
- Participants with ability to receive text messaging access to smart device
Who cannot join
- Report currently smoking menthol cigarettes
- People who do not report currently smoking menthol cigarettes
- Individuals under 18 years of age
- Persons in correctional facilities
- Non-English speaking
- Participants who cannot receive text messaging or have access to smart device
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: An Exploratory Investigation on Effectiveness of Tailored New York State Quitline Services for Cessation of Menthol Tobacco Cigarettes
This clinical trial compares the impact of receiving educational materials containing relevant content about risks from smoking menthol cigarettes which include links to the New York (NY) Smoke-Free website by text message or mail in people who smoke menthol cigarettes. The NY Smoke-Free website includes tailored content developed specifically for menthol smokers and provides resources designed to resonate with the experiences of menthol smokers and address the unique challenges they face in quitting. Delivering tailored educational materials by text message or mail may increase interaction with information about menthol cigarettes and smoking cessation resources compared to those who do not receive the educational messaging.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess participant interaction with an educational message about menthol cigarettes by tracking visits to the Quitline website.
II. Assess participant interaction with the educational message delivered by text message with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web site.
III. Assess participant interaction with the educational message delivery by mail with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and quick response (QR) code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
GROUP II: Participants receive standard Quitline materials in the mail on study.
GROUP III: Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Educational Intervention, Internet-Based Intervention, Smartphone Application-based Intervention, Smoking Cessation Intervention, Text Message-Based Navigation Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive an educational flyer by mail
Internet-Based InterventionOther
Receive access to a website
Smartphone Application-based InterventionBehavioural
Also called Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based Intervention
Receive access to a QR code
Smoking Cessation InterventionBehavioural
Also called Smoking and Tobacco Use Cessation Interventions
Receive standard Quitline materials
Text Message-Based Navigation InterventionOther
Also called Automated Text Message-Based Navigation, Text Message-Based Navigation
Receive an educational message by text
| Study group | Role | What they receive |
|---|---|---|
| Cohort II (standard Quitline materials) | Active comparator | Participants receive standard Quitline materials in the mail on study. Receives: Behavioral: Smoking Cessation Intervention |
| Group I (educational material by mail) | Experimental | Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. Receives: Other: Educational Intervention; Other: Internet-Based Intervention; Behavioral: Smartphone Application-based Intervention; Behavioral: Smoking Cessation Intervention |
| Group III (educational messaging by text) | Experimental | Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. Receives: Other: Internet-Based Intervention; Behavioral: Smartphone Application-based Intervention; Behavioral: Smoking Cessation Intervention; Other: Text Message-Based Navigation Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement with quick response (QR) code scans
QR code will be scanned will be tracked through unique uniform resource locator assigned. Each scan will be documented, allowing for the counting of interactions (Poisson) directly affiliated with the materials distributed. Also, binary (yes/no) (Did the participant interact at least once). Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3).
Measured: Up to 12 months
Website Utilization
total number of visits, unique visitors,
Measured: Up to 12 months
Interactions with online resources
Interactions with online resources will include the number of clicks on website, and time spent on various pages. Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3).
Measured: Up to 12 months
Website utilization
Duration of sessions
Measured: Up to 12 months
Secondary outcomes (6)
Number of website interactions from the mailed flyer
Will measure participant engagement with the menthol educational materials.
Measured: Up to 12 months
Number of QR code interactions from the mailed flyer
Will measure participant engagement with the menthol educational materials.
Measured: Up to 12 months
Number of website interactions from the text message
Will measure participant engagement with the menthol educational materials.
Measured: Up to 12 months
Number of QR code interactions from the text message
Will measure participant engagement with the menthol educational materials.
Measured: Up to 12 months
Duration spent on the cessation website
Will assess depth of engagement.
Measured: Up to 12 months
Number of pages or resources accessed on the website
Will evaluate participant utilization of the content.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start8 Aug 2025
- Primary completion12 Dec 2025
- Study completion12 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Pearson-Collins, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857681
- Sponsor's protocol ID
- I-4464925
- Other IDs
- NCI-2025-03221, I-4464925
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation on Effectiveness of Tailored New York State Quitline Services for Cessation of Menthol Tobacco Cigarettes
- ClinicalTrials.gov ID
- NCT07857681
- Acronym / sponsor ID
- I-4464925
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 8 Aug 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 12 Dec 2026 (estimated)
- First posted
- 5 Oct 2026 (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.
This clinical trial compares the impact of receiving educational materials containing relevant content about risks from smoking menthol cigarettes which include links to the New York (NY) Smoke-Free website by text message or mail in people who smoke menthol cigarettes. The NY Smoke-Free website includes tailored content developed specifically for menthol smokers and provides resources designed to resonate with the experiences of menthol smokers and address the unique challenges they face in quitting. Delivering tailored educational materials by text message or mail may increase interaction with information about menthol cigarettes and smoking cessation resources compared to those who do not receive the educational messaging.
Detailed description
PRIMARY OBJECTIVES:
- Assess participant interaction with an educational message about menthol cigarettes by tracking visits to the Quitline website.
II. Assess participant interaction with the educational message delivered by text message with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web site.
III. Assess participant interaction with the educational message delivery by mail with a direct link to information about menthol cigarettes by tracking visits to the Quitline Web.
OUTLINE: Participants are randomized to 1 of 3 groups.
GROUP I: Participants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and quick response (QR) code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
GROUP II: Participants receive standard Quitline materials in the mail on study.
GROUP III: Participants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort II (standard Quitline materials) | Active comparator | Behavioral: Smoking Cessation InterventionParticipants receive standard Quitline materials in the mail on study. |
| Group I (educational material by mail) | Experimental | Other: Educational Intervention, Other: Internet-Based Intervention, Behavioral: Smartphone Application-based Intervention, Behavioral: Smoking Cessation InterventionParticipants receive an educational flyer by mail along with the standard Quitline materials on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
| Group III (educational messaging by text) | Experimental | Other: Internet-Based Intervention, Behavioral: Smartphone Application-based Intervention, Behavioral: Smoking Cessation Intervention, Other: Text Message-Based Navigation InterventionParticipants receive an educational message by text along with the standard Quitline materials by mail on study. Participants receive access to a website and QR code directing them to culturally tailored information about menthol cigarettes and cessation on the NY Smoke-Free website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 years or older
- Residents of New York State
- English Speaking
- Willingness to receive and engage with mailed educational materials
- Participants with ability to receive text messaging access to smart device
Key exclusion criteria (6 listed)
- Report currently smoking menthol cigarettes
- People who do not report currently smoking menthol cigarettes
- Individuals under 18 years of age
- Persons in correctional facilities
- Non-English speaking
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 |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive an educational flyer by mail | Other | Group I (educational material by mail) |
| Internet-Based InterventionReceive access to a website | Other | Group I (educational material by mail), Group III (educational messaging by text) |
| Smartphone Application-based InterventionAlso: Smartphone App-based Intervention, Smartphone Intervention, Smartphone-based InterventionReceive access to a QR code | Behavioural | Group I (educational material by mail), Group III (educational messaging by text) |
| Smoking Cessation InterventionAlso: Smoking and Tobacco Use Cessation InterventionsReceive standard Quitline materials | Behavioural | Cohort II (standard Quitline materials), Group I (educational material by mail), Group III (educational messaging by text) |
| Text Message-Based Navigation InterventionAlso: Automated Text Message-Based Navigation, Text Message-Based NavigationReceive an educational message by text | Other | Group III (educational messaging by text) |
Primary outcome
Engagement with quick response (QR) code scans
Time frame: Up to 12 months
QR code will be scanned will be tracked through unique uniform resource locator assigned. Each scan will be documented, allowing for the counting of interactions (Poisson) directly affiliated with the materials distributed. Also, binary (yes/no) (Did the participant interact at least once). Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3).
Website Utilization
Time frame: Up to 12 months
total number of visits, unique visitors,
Interactions with online resources
Time frame: Up to 12 months
Interactions with online resources will include the number of clicks on website, and time spent on various pages. Will be analyzed using chi-square tests or Fisher's exact tests. Bonferroni's correction will be used to adjust for three pairwise comparisons (alpha=0.05/3).
Website utilization
Time frame: Up to 12 months
Duration of sessions
6 secondary outcomes
Number of website interactions from the mailed flyer
Time frame: Up to 12 months
Number of QR code interactions from the mailed flyer
Time frame: Up to 12 months
Number of website interactions from the text message
Time frame: Up to 12 months
Number of QR code interactions from the text message
Time frame: Up to 12 months
Duration spent on the cessation website
Time frame: Up to 12 months
Number of pages or resources accessed on the website
Time frame: Up to 12 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 5 Oct 2026.
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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. This study is not recruiting at the moment.
Sarah Pearson-Collins principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Internet-Based Intervention and Smartphone Application-based Intervention in people with Cigarette Smoking-Related Carcinoma, run by Roswell Park Cancer Institute at 1 site in United States.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement with quick response (QR) code scans (time frame: Up to 12 months). The study lists 4 primary outcomes in all. 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 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.