NCT07754448

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
18mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Aug 2026Feb 2028

First Submitted

Initial submission to the registry

July 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.5 years

First QC Date

July 29, 2026

Last Update Submit

August 4, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (7)

  • 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.

    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.

    Up to 18 Months

  • Feasibility - Screening Rate

    Number of potential participants screened to participate in the study.

    Up to 18 Months

  • Feasibility - Enrollment Rate

    Number of screened eligible participants who enroll in the study.

    Up to 18 Months

  • Feasibility - Baseline Assessment Completion

    Number of enrolled participants who complete all baseline questionnaires.

    Baseline

  • Feasibility - Retention at 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

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

    Up to 18 months

Study Arms (3)

Arm 1: Smartphone app

EXPERIMENTAL

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

Behavioral: Libre del Cigarrillo Smartphone App

Arm 2: Printed booklets

EXPERIMENTAL

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

Behavioral: Libre del Cigarrillo Printed Booklets

Arm 3: SmokefreeTXT

EXPERIMENTAL

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

Behavioral: SmokefreeTXT en Español

Interventions

Libre del Cigarrillo Smartphone AppBEHAVIORAL

Participants receive full access to the culturally adapted cessation app.

Arm 1: Smartphone app
SmokefreeTXT en EspañolBEHAVIORAL

NCI Text-Messaging Program

Arm 3: SmokefreeTXT
Libre del Cigarrillo Printed BookletsBEHAVIORAL

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

Arm 2: Printed booklets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Self-identify as Hispanic/Latinx.
  • + 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Vani Simmons, PhD

    Moffitt Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Almendares

CONTACT

813-745-7863Maria.Almendares@moffitt.org

Marilyn Horta, PhD

CONTACT

813-745-3861Marilyn.Horta@moffitt.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2026

First Posted

August 10, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

August 10, 2026

Record last verified: 2026-07

Locations

US(1)