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

September 14, 2026 updated by: H. Lee Moffitt Cancer Center and Research Institute
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
        • Sub-Investigator:
          • Steven Sutton, PhD
        • Sub-Investigator:
          • Cathy Meade, PhD
        • Principal Investigator:
          • Vani Simmons, PhD
        • Sub-Investigator:
          • Christine Vinci, PhD
        • Sub-Investigator:
          • Jennifer Vidrine, PhD
        • Sub-Investigator:
          • Ursula Martinez, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Smartphone app
Participants receive access to the finalized Libre del Cigarrillo smoking-cessation app.
Behavioral: Libre del Cigarrillo Smartphone App
Participants receive full access to the culturally adapted cessation app.
Experimental: Arm 2: Printed booklets
Participants receive the culturally tailored Libre del Cigarrillo printed self-help booklets.
Behavioral: Libre del Cigarrillo Printed Booklets
The validated Spanish-language booklet series previously shown to increase long-term abstinence.
Experimental: Arm 3: SmokefreeTXT
Participants receive NCI's automated Spanish-language SmokefreeTXT text-messaging cessation program.
Behavioral: SmokefreeTXT en Español
NCI Text-Messaging Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 18 Months
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.
Up to 18 Months
Feasibility - Screening Rate
Time Frame: Up to 18 Months
Number of potential participants screened to participate in the study.
Up to 18 Months
Feasibility - Enrollment Rate
Time Frame: Up to 18 Months
Number of screened eligible participants who enroll in the study.
Up to 18 Months
Feasibility - Baseline Assessment Completion
Time Frame: Baseline
Number of enrolled participants who complete all baseline questionnaires.
Baseline
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.
Up to 18 months
Feasibility - Biochemical Verification
Time Frame: Up to 18 months
Number of participants self-reporting abstinence who returned saliva samples for cotinine verification.
Up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Vani Simmons, PhD, Moffitt Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

July 29, 2026

First Submitted That Met QC Criteria

August 4, 2026

First Posted (Actual)

August 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-23497
  • R34CA297368 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe