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NCT Number: NCT07754448

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

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location contact

Cathy Meade, PhD

SUB_INVESTIGATOR

Christine Vinci, PhD

SUB_INVESTIGATOR

Jennifer Vidrine, PhD

SUB_INVESTIGATOR

Steven Sutton, PhD

SUB_INVESTIGATOR

Ursula Martinez, PhD

SUB_INVESTIGATOR

Vani Simmons, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Libre del Cigarrillo Smartphone App

Behavioral

Participants receive full access to the culturally adapted cessation app.

Libre del Cigarrillo Printed Booklets

Behavioral

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

SmokefreeTXT en Español

Behavioral

NCI Text-Messaging Program

Primary outcomes

  1. 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.

  2. 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.

  3. Feasibility - Screening Rate

    Time frame: Up to 18 Months

    Number of potential participants screened to participate in the study.

  4. Feasibility - Enrollment Rate

    Time frame: Up to 18 Months

    Number of screened eligible participants who enroll in the study.

  5. Feasibility - Baseline Assessment Completion

    Time frame: Baseline

    Number of enrolled participants who complete all baseline questionnaires.

  6. 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.

  7. Feasibility - Biochemical Verification

    Time frame: Up to 18 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Almendares

CONTACT

[email protected]

813-745-7863

Marilyn Horta, PhD

CONTACT

[email protected]

813-745-3861

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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