Smoking CessationProject mFLiNCT06909357
Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients
A study testing Quitline Treatment (QT) and App-based Treatment (mHealth) in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites in United States.
Trial summary
Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Quitline Treatment (QT) and App-based Treatment (mHealth)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Mar 2025to 26 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- ≥18 years of age.
- ≥100 lifetime cigarettes.
- English-speaking.
- Report smoking ≥ 1 cigarette in past 30 days.
- Working smartphone.
Who cannot join
- Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.
- Currently pregnant or breastfeeding.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami
Coral Gables, Florida, 33146
University of Florida
Gainesville, Florida, 23611
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida
Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.
- Conditions
- Smoking Cessation
- Being tested
- Quitline Treatment (QT), App-based Treatment (mHealth)
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quitline Treatment (QT)Other
Tobacco Free Florida Quitline. 10-week supply of Combination Nicotine Replacement Therapy (NRT).
App-based Treatment (mHealth)Other
Fully automated digitally-delivered smoking cessation intervention targeted to cancer patients. 10-week supply of Combination Nicotine Replacement Therapy (NRT).
| Study group | Role | What they receive |
|---|---|---|
| Demonstration Project 1 | No intervention | Screening and recruitment of cancer patients for connection to evidence-based smoking cessation treatment. The goal of the first demonstration project is to develop a feasible and effective method for screening cancer patients for smoking, determining treatment eligibility, and offering treatment. |
| Demonstration Project 2 | Experimental | Pilot RCT of Quitline vs. Mobile-Delivered Smoking Cessation Intervention for Cancer Patients. The goal of this pilot feasibility study is two-fold: to evaluate the performance of the platform itself and to provide preliminary data for a future efficacy trial. Receives: Other: Quitline Treatment (QT); Other: App-based Treatment (mHealth) |
| Demonstration Project 3 | No intervention | Utilizing machine learning to process data obtained from demonstration projects 1 and 2. In Demonstration Project 3, we will utilize all data collected in Demonstration Projects 1 and 2 to conduct machine and deep learning methods. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Screening
Our screening process will be deemed feasible if: 1) ≥ 90% of patients complete the screener, 2) the proportion of patients identified as smokers meets or exceeds the historical self-reported proportions at each institution, 3) the program correctly identifies eligible participants and subsequently presents automated advice to quit, 4) it offers an opportunity to enroll in smoking cessation treatment, and 5) ≥ 30% of eligible patients enroll in treatment.
Measured: At Baseline
Usability: mHealth
Usability will be measured 2 ways: I) ≥ 80% will score ≥ 70 on the Systems Usability Scale (SUS), 10-item measure, (scores 0-100) assessing learnability and usability. II) ≥ 80% rate app as easy to use (dichotomous Y/N).
Measured: Up to 6 Months
Acceptability/Satisfaction: mHealth
Acceptability/Satisfaction will be measured 4 ways: I) ≥ 80 will score mean ≥ 3.0 Client Satisfaction Questionnaire (CSQ), 8-item measure, (1-4 scale). II) ≥ 80% mostly or extremely satisfied with app. III) ≥ 80% would recommend this app to a friend to quit smoking (dichotomous Y/N). IV) ≥ 80% rate quality of intervention as good or excellent.
Measured: Up to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start28 Mar 2025
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Biomedical Research Program - James & Esther King
- Responsible party
- Sponsor
- Investigators
- Damon Vidrine, DrPH, Principal investigator, Moffitt Cancer CenterVani Simmons, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909357
- Sponsor's protocol ID
- MCC-23179
- Acronym
- Project mFLi
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sparrock LS, Vidrine JI, Vinci CE, El Naqa IM, Sutton SK, Salloum RG, Dallery J, Crane TE, Penedo FJ, Brockway SJ, Jones SR, Hoogland CE, Reich RR, Gonzalez-Calderon G, Simmons VN, Vidrine DJ. Creation of an mHealth Infrastructure to Support the Development and Delivery of mHealth Interventions: Protocol for Demonstration Projects Addressing Smoking Cessation in Cancer Care. JMIR Res Protoc. 2026 May 29;15:e92288. doi: 10.2196/92288.
PubMed 42214073
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of an Infrastructure to Support Delivery of mHealth Interventions for Cancer Patients Throughout Florida
- ClinicalTrials.gov ID
- NCT06909357
- Acronym / sponsor ID
- Project mFLi / MCC-23179
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Florida Biomedical Research Program - James & Esther King
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 3 Apr 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.
Despite the deleterious impact of smoking upon cancer treatment outcomes, smoking prevalence remains alarmingly high among cancer patients. Thus, reducing smoking by cancer patients is a public health priority, but treatments to date have demonstrated limited efficacy. Mobile health (mHealth) interventions have the potential to improve treatment efficacy while also greatly extending reach. The goal of this infrastructure proposal is to build a resource to facilitate the creation of mHealth tools that address the tobacco treatment needs of cancer patients. This resource, which will be available to researchers throughout Florida, would fill a critical gap in mHealth capacity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Demonstration Project 1 | No intervention | –Screening and recruitment of cancer patients for connection to evidence-based smoking cessation treatment. The goal of the first demonstration project is to develop a feasible and effective method for screening cancer patients for smoking, determining treatment eligibility, and offering treatment. |
| Demonstration Project 2 | Experimental | Other: Quitline Treatment (QT), Other: App-based Treatment (mHealth)Pilot RCT of Quitline vs. Mobile-Delivered Smoking Cessation Intervention for Cancer Patients. The goal of this pilot feasibility study is two-fold: to evaluate the performance of the platform itself and to provide preliminary data for a future efficacy trial. |
| Demonstration Project 3 | No intervention | –Utilizing machine learning to process data obtained from demonstration projects 1 and 2. In Demonstration Project 3, we will utilize all data collected in Demonstration Projects 1 and 2 to conduct machine and deep learning methods. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age.
- ≥100 lifetime cigarettes.
- English-speaking.
- Report smoking ≥ 1 cigarette in past 30 days.
- Working smartphone.
Key exclusion criteria (2 listed)
- Failure to electronically confirm participation within 14 days of randomization via electronic link sent to participant's smartphone.
- Currently pregnant or breastfeeding.
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 |
|---|---|---|
| Quitline Treatment (QT)Tobacco Free Florida Quitline. 10-week supply of Combination Nicotine Replacement Therapy (NRT). | Other | Demonstration Project 2 |
| App-based Treatment (mHealth)Fully automated digitally-delivered smoking cessation intervention targeted to cancer patients. 10-week supply of Combination Nicotine Replacement Therapy (NRT). | Other | Demonstration Project 2 |
Primary outcome
Feasibility: Screening
Time frame: At Baseline
Our screening process will be deemed feasible if: 1) ≥ 90% of patients complete the screener, 2) the proportion of patients identified as smokers meets or exceeds the historical self-reported proportions at each institution, 3) the program correctly identifies eligible participants and subsequently presents automated advice to quit, 4) it offers an opportunity to enroll in smoking cessation treatment, and 5) ≥ 30% of eligible patients enroll in treatment.
Usability: mHealth
Time frame: Up to 6 Months
Usability will be measured 2 ways: I) ≥ 80% will score ≥ 70 on the Systems Usability Scale (SUS), 10-item measure, (scores 0-100) assessing learnability and usability. II) ≥ 80% rate app as easy to use (dichotomous Y/N).
Acceptability/Satisfaction: mHealth
Time frame: Up to 6 Months
Acceptability/Satisfaction will be measured 4 ways: I) ≥ 80 will score mean ≥ 3.0 Client Satisfaction Questionnaire (CSQ), 8-item measure, (1-4 scale). II) ≥ 80% mostly or extremely satisfied with app. III) ≥ 80% would recommend this app to a friend to quit smoking (dichotomous Y/N). IV) ≥ 80% rate quality of intervention as good or excellent.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Derived from this study: PubMed 42214073Sparrock LS, Vidrine JI, Vinci CE, El Naqa IM, Sutton SK, Salloum RG, Dallery J, Crane TE, Penedo FJ, Brockway SJ, Jones SR, Hoogland CE, Reich RR, Gonzalez-Calderon G, Simmons VN, Vidrine DJ. Creation of an mHealth Infrastructure to Support the Development and Delivery of mHealth Interventions: Protocol for Demonstration Projects Addressing Smoking Cessation in Cancer Care. JMIR Res Protoc. 2026 May 29;15:e92288. doi: 10.2196/92288.
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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.
Damon Vidrine, DrPH principal investigator
Moffitt Cancer Center
Vani Simmons, PhD principal investigator
Moffitt Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quitline Treatment (QT) and App-based Treatment (mHealth) in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 3 sites 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 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: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility: Screening (time frame: At Baseline). The study lists 3 primary outcomes in all. 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 NCT06909357, which also lists 1 linked publication.
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 15 Sep 2026.