Smoking CessationNCT07754448
Libre Del Cigarrillo: Development of an mHealth Smoking Cessation App to Extend Reach of a Validated Smoking Cessation Intervention for Spanish-speaking Smokers
A study testing Libre del Cigarrillo Smartphone App, Libre del Cigarrillo Printed Booklets and SmokefreeTXT en Español in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
Pilot randomized controlled trial evaluating feasibility, acceptability, and trial-readiness of the new app compared with the existing print booklets and the NCI SmokefreeTXT en Español program. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Libre del Cigarrillo Smartphone App, Libre del Cigarrillo Printed Booklets and SmokefreeTXT en Español
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Feb 2028
- 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
- Self-identify as Hispanic/Latinx.
- 18+ Years of age.
- Monolingual Spanish-speaking, or bilingual Spanish-English and prefer educational health materials in Spanish.
- Have been smoking at least 5 cigarettes per week over the past year
- Not currently enrolled in a face-to-face or virtual smoking cessation program.
Who cannot join
- A household member enrolled in the study.
- Prior participation in the LDC randomized controlled trial.
- Prior use of the NCI SmokefreeTXT program.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Moffitt Cancer Center
Tampa, Florida, 33612
Vani Simmons, PhD
Christine Vinci, PhD
About this study
Pilot randomized controlled trial evaluating feasibility, acceptability, and trial-readiness of the new app compared with the existing print booklets and the NCI SmokefreeTXT en Español program.
- Conditions
- Smoking Cessation
- Being tested
- Libre del Cigarrillo Smartphone App, Libre del Cigarrillo Printed Booklets, SmokefreeTXT en Español
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Libre del Cigarrillo Smartphone AppBehavioural
Participants receive full access to the culturally adapted cessation app.
Libre del Cigarrillo Printed BookletsBehavioural
The validated Spanish-language booklet series previously shown to increase long-term abstinence.
SmokefreeTXT en EspañolBehavioural
NCI Text-Messaging Program
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Smartphone app | Experimental | Participants receive access to the finalized Libre del Cigarrillo smoking-cessation app. Receives: Behavioral: Libre del Cigarrillo Smartphone App |
| Arm 2: Printed booklets | Experimental | Participants receive the culturally tailored Libre del Cigarrillo printed self-help booklets. Receives: Behavioral: Libre del Cigarrillo Printed Booklets |
| Arm 3: SmokefreeTXT | Experimental | Participants receive NCI's automated Spanish-language SmokefreeTXT text-messaging cessation program. Receives: Behavioral: SmokefreeTXT en Español |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability - System Usability Scale
Participants' perceptions of the app's usability in the app arm will be measured using 10 items on a 5-point Likert Scale. Scores range from 0 to 100, with higher scores indicating better usability.
Measured: Up to 18 Months
Acceptability - Client Satisfaction Questionnaire (CSQ)
Participants' satisfaction with the LDC app will be measured using the Client Satisfaction Questionnaire (CSQ). The questionnaire consists of 8 items rated on a 4-point Likert scale, with higher scores indicating greater overall satisfaction.
Measured: Up to 18 Months
Feasibility - Screening Rate
Number of potential participants screened to participate in the study.
Measured: Up to 18 Months
Feasibility - Enrollment Rate
Number of screened eligible participants who enroll in the study.
Measured: Up to 18 Months
Feasibility - Baseline Assessment Completion
Number of enrolled participants who complete all baseline questionnaires.
Measured: Baseline
Feasibility - Retention at 18 Months
Number of participants in each of the arms that completed the 18-month follow-up assessment.
Measured: Up to 18 months
Feasibility - Biochemical Verification
Number of participants self-reporting abstinence who returned saliva samples for cotinine verification.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Vani Simmons, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754448
- Sponsor's protocol ID
- MCC-23497
- Other IDs
- R34CA297368
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2026
- Last updated
- 15 Sep 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 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Libre Del Cigarrillo: Development of an mHealth Smoking Cessation App to Extend Reach of a Validated Smoking Cessation Intervention for Spanish-speaking Smokers
- ClinicalTrials.gov ID
- NCT07754448
- Acronym / sponsor ID
- MCC-23497
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 10 Aug 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.
Pilot randomized controlled trial evaluating feasibility, acceptability, and trial-readiness of the new app compared with the existing print booklets and the NCI SmokefreeTXT en Español program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Smartphone app | Experimental | Behavioral: Libre del Cigarrillo Smartphone AppParticipants receive access to the finalized Libre del Cigarrillo smoking-cessation app. |
| Arm 2: Printed booklets | Experimental | Behavioral: Libre del Cigarrillo Printed BookletsParticipants receive the culturally tailored Libre del Cigarrillo printed self-help booklets. |
| Arm 3: SmokefreeTXT | Experimental | Behavioral: SmokefreeTXT en EspañolParticipants receive NCI's automated Spanish-language SmokefreeTXT text-messaging cessation program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Self-identify as Hispanic/Latinx.
- 18+ Years of age.
- Monolingual Spanish-speaking, or bilingual Spanish-English and prefer educational health materials in Spanish.
- Have been smoking at least 5 cigarettes per week over the past year
- Not currently enrolled in a face-to-face or virtual smoking cessation program.
Key exclusion criteria (3 listed)
- A household member enrolled in the study.
- Prior participation in the LDC randomized controlled trial.
- Prior use of the NCI SmokefreeTXT program.
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 |
|---|---|---|
| Libre del Cigarrillo Smartphone AppParticipants receive full access to the culturally adapted cessation app. | Behavioural | Arm 1: Smartphone app |
| Libre del Cigarrillo Printed BookletsThe validated Spanish-language booklet series previously shown to increase long-term abstinence. | Behavioural | Arm 2: Printed booklets |
| SmokefreeTXT en EspañolNCI Text-Messaging Program | Behavioural | Arm 3: SmokefreeTXT |
Primary outcome
Usability - System Usability Scale
Time frame: Up to 18 Months
Participants' perceptions of the app's usability in the app arm will be measured using 10 items on a 5-point Likert Scale. Scores range from 0 to 100, with higher scores indicating better usability.
Acceptability - Client Satisfaction Questionnaire (CSQ)
Time frame: Up to 18 Months
Participants' satisfaction with the LDC app will be measured using the Client Satisfaction Questionnaire (CSQ). The questionnaire consists of 8 items rated on a 4-point Likert scale, with higher scores indicating greater overall satisfaction.
Feasibility - Screening Rate
Time frame: Up to 18 Months
Number of potential participants screened to participate in the study.
Feasibility - Enrollment Rate
Time frame: Up to 18 Months
Number of screened eligible participants who enroll in the study.
Feasibility - Baseline Assessment Completion
Time frame: Baseline
Number of enrolled participants who complete all baseline questionnaires.
Feasibility - Retention at 18 Months
Time frame: Up to 18 months
Number of participants in each of the arms that completed the 18-month follow-up assessment.
Feasibility - Biochemical Verification
Time frame: Up to 18 months
Number of participants self-reporting abstinence who returned saliva samples for cotinine verification.
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 15 Sep 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.
Vani Simmons, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Libre del Cigarrillo Smartphone App, Libre del Cigarrillo Printed Booklets and SmokefreeTXT en Español in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research 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 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 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 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?
Contact Maria Almendares (813-745-7863, Maria.Almendares@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability - System Usability Scale (time frame: Up to 18 Months). The study lists 7 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 15 Sep 2026.