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Not yet recruitingNCT07754448Updated Sep 15, 2026

Libre Del Cigarrillo: Development of an mHealth Smoking Cessation App to Extend Reach of a Validated Smoking Cessation Intervention for Spanish-speaking Smokers

An interventional study of Libre del Cigarrillo Smartphone App and Libre del Cigarrillo Printed Booklets in Smoking Cessation, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Smoking Cessation

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03

In context

Smoking Cessation

1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

This study's planned enrollment of 120 is below the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.

Browse Smoking Cessation studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • A household member enrolled in the study.
  • Prior participation in the LDC randomized controlled trial.
  • Prior use of the NCI SmokefreeTXT program.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Arm 1: Smartphone app

    Participants receive access to the finalized Libre del Cigarrillo smoking-cessation app.

    Behavioral: Libre del Cigarrillo Smartphone App

  • Experimental
    Arm 2: Printed booklets

    Participants receive the culturally tailored Libre del Cigarrillo printed self-help booklets.

    Behavioral: Libre del Cigarrillo Printed Booklets

  • Experimental
    Arm 3: SmokefreeTXT

    Participants receive NCI's automated Spanish-language SmokefreeTXT text-messaging cessation program.

    Behavioral: SmokefreeTXT en Español

Interventions

  • BehavioralLibre del Cigarrillo Smartphone App

    Participants receive full access to the culturally adapted cessation app.

  • BehavioralLibre del Cigarrillo Printed Booklets

    The validated Spanish-language booklet series previously shown to increase long-term abstinence.

  • BehavioralSmokefreeTXT en Español

    NCI Text-Messaging Program

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 18 Months

  2. 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.

    Time frame: Up to 18 Months

  3. Feasibility - Screening Rate

    Number of potential participants screened to participate in the study.

    Time frame: Up to 18 Months

  4. Feasibility - Enrollment Rate

    Number of screened eligible participants who enroll in the study.

    Time frame: Up to 18 Months

  5. Feasibility - Baseline Assessment Completion

    Number of enrolled participants who complete all baseline questionnaires.

    Time frame: Baseline

  6. Feasibility - Retention at 18 Months

    Number of participants in each of the arms that completed the 18-month follow-up assessment.

    Time frame: Up to 18 months

  7. Feasibility - Biochemical Verification

    Number of participants self-reporting abstinence who returned saliva samples for cotinine verification.

    Time frame: Up to 18 months

07

Study locations

1 site
  • Moffitt Cancer Center
    Tampa, Florida 33612, United States
    • Vani Simmons, PhD · Principal investigator
    • Christine Vinci, PhD · Sub investigator
    • Jennifer Vidrine, PhD · Sub investigator
    • Cathy Meade, PhD · Sub investigator
    • Steven Sutton, PhD · Sub investigator
    • Ursula Martinez, PhD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07754448
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 2028 (estimated)
Completion
Feb 2028 (estimated)
Last update
Sep 15, 2026

Study contacts

Maria Almendares
Contact
Maria.Almendares@moffitt.org
813-745-7863
Marilyn Horta, PhD
Contact
Marilyn.Horta@moffitt.org
813-745-3861
Vani Simmons, PhD
principal investigator · Moffitt Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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