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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

A household member enrolled in the study.

Prior participation in the LDC randomized controlled trial.

Prior use of the NCI SmokefreeTXT program.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Arm 1: Smartphone appExperimental treatment 1 intervention
Group B: Arm 2: Printed bookletsExperimental treatment 1 intervention
Group C: Arm 3: SmokefreeTXTExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: