Smoking Cessation
Conditions
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.
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
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usability - System Usability Scale | 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. |
| Acceptability - Client Satisfaction Questionnaire (CSQ) | 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. |
| Feasibility - Screening Rate | Up to 18 Months | Number of potential participants screened to participate in the study. |
| Feasibility - Enrollment Rate | Up to 18 Months | Number of screened eligible participants who enroll in the study. |
| Feasibility - Baseline Assessment Completion | Baseline | Number of enrolled participants who complete all baseline questionnaires. |
| Feasibility - Retention at 18 Months | Up to 18 months | Number of participants in each of the arms that completed the 18-month follow-up assessment. |
| Feasibility - Biochemical Verification | Up to 18 months | Number of participants self-reporting abstinence who returned saliva samples for cotinine verification. |
Countries
United States
Contacts
CONTACTMaria Almendares
CONTACTMarilyn Horta, PhD
PRINCIPAL_INVESTIGATORVani Simmons, PhD
Moffitt Cancer Center
Outcome results
None listed