Mobile Cessation Support for Latino Smokers

NCT03586596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2024-04-12

No results posted yet for this study

Summary

The primary aim of this study is to examine the efficacy of Decídetexto, an innovative mobile smoking cessation intervention that incorporates two elements: 1) a tablet-based e-Health platform that collects personal smoking-related information to support the development of an individualized quit plan and guides the ensuing text messaging program; and 2) a 12-week text messaging "skills-based counseling" (I.e, behavioral support) program that includes educational information, behavioral strategies, motivational messaging, and pharmacotherapy support driven by information obtained from both the tablet program and the user's text messages. The investigators will evaluate its efficacy relative to a standard care condition that provides high quality printed smoking cessation materials along with referral to telephone quit line counseling. Participants in both groups are given access to free pharmacotherapy via a toll-free study number. Experienced Promotores de Salud (Community Health Workers) will use community and clinic-based outreach to recruit Latino smokers into the study. Participants in both conditions will complete follow-up assessment at the end of treatment (Week 12) and Month 6 (primary outcome). Our hypothesis is that at month 6, smokers in Decídetexto will have significantly higher cotinine-verified 7-day point prevalence abstinence (no cigarettes in the past 7 days) than smokers in the control arm.

Conditions

  • Smoking Cessation

Interventions

BEHAVIORAL

The Decídetext program

Decídetext participants will be directed to the tablet-based software. Participants will receive an interactive education session that will lead them through language-appropriate, culturally-relevant information about stopping smoking, collection of basic smoking history data, and choices/plans about preparing to quit. Quit plans include: 1) choice of quit date, 2) NRT preference, 3) plan to remove smoking cues, 4) identification of trigger situations and 5) choice of suggested coping strategies. Participant data and choices are used to generate a printed 1-page individualized treatment plan. Tablet components, assessment items, audio narrative, brief multimedia instructional video clips, and the printed treatment plan have been developed to address low-literacy levels.

BEHAVIORAL

Standard Care Control

Educational Material provided as of suggested by American Cancer Society and, the National Cancer Institute

Sponsors & Collaborators

  • Lombardi Comprehensive Cancer Center

    collaborator OTHER
  • Children's Mercy Hospital Kansas City

    collaborator OTHER
  • University of Kansas Medical Center

    collaborator OTHER
  • University of Rochester

    lead OTHER

Principal Investigators

  • Ana Paula Cupertino, PhD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2021-09-08
Completion
2021-09-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03586596 on ClinicalTrials.gov