Mobile Cessation Support for Latino Smokers

NCT03586596 | Completed

• 1 other identifier: Pro2017-0528
• Study Type: interventional
• Target: 457
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Smokers; Mobile intervention; Latino; Promotores de Salud; Pharmacotherapy; Cultural accomodation; Tobacco use; Health Disparities; Cancer Disparities

Outcome Measures

Primary Outcomes (1)

• Cotinine-verified 7-day point prevalence at 6 months.

  Participants who quit will do a cotinine-verified 7-day point prevalence check at Month 6.

  6 months

Secondary Outcomes (1)

• 12- week self-report

  12 weeks

Study Arms (2)

The Decídetext program

EXPERIMENTAL

Participants will receive a tablet-based interactive educational session, 6 months of text-messaging based counseling, which includes prompts to access free pharmacotherapy.

Behavioral: The Decídetext program

Standard Care Control

ACTIVE COMPARATOR

Participants will receive an adapted version of standard printed smoking cessation educational materials from the American Cancer Society and, the National Cancer Institute, which include information about the health risks of smoking, benefits \& strategies for quitting and access to free pharmacotherapy by calling a free number.

Behavioral: Standard Care Control

Interventions

The Decídetext program BEHAVIORAL

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.

The Decídetext program

Standard Care Control BEHAVIORAL

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

Standard Care Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are you Hispanic or Latino?
• Do you know how to read and speak English and/or Spanish?
• Are you at least 21 years old?
• Have you smoked cigarettes for at least 6 months?
• Within a typical week, how many days do you smoke (even a puff)?
• Within a typical week, how many days do use other tobacco products?
• Are you interested in quitting smoking in the next 30 days?
• Are you currently participating in any other smoking cessation program or taking any type of medication to quit smoking?
• Is any household member participating in this study?
• Are you pregnant, breast-feeding or planning to become pregnant in the next year?
• Are you planning to move out of your current address in the following six months?
• Do you have an active cellphone with unlimited text messaging capability?
• Are you willing to come to 2 study visit, at the beginning and 6 month, and get at least 1 phone calls between visits?
• Do you know how to send/read text messages?
• Is the participant ELIGIBLE? If NOT ELIGIBLE, complete demographics If ELIGIBLE, complete contact information.

You may not qualify if:

• Include plans to move from New Jersey in the next 6 months
• If another household member enrolled in the study.
• If answers no to any question of the Eligibility form.

Sponsors & Collaborators

• University of Rochester: lead
• Lombardi Comprehensive Cancer Center: collaborator
• Children's Mercy Hospital Kansas City: collaborator
• University of Kansas Medical Center: collaborator

Study Sites (3)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Hackensack Meridian Health - Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

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• Cartujano-Barrera F, Cox LS, Catley D, Cai X, Diaz FJ, Arana-Chicas E, Chavez-Iniguez A, Ogedegbe C, Graves KD, Rivera MP, Ponce A, Ellerbeck EF, Cupertino AP. Decidetexto: Mobile Cessation Support for Latino Adults Who Smoke: A Randomized Clinical Trial. Chest. 2025 Feb;167(2):619-629. doi: 10.1016/j.chest.2024.07.160. Epub 2024 Aug 10.

  PMID: 39134144 DERIVED

• Arana-Chicas E, Cartujano-Barrera F, Rieth KK, Richter KK, Ellerbeck EF, Cox LS, Graves KD, Diaz FJ, Catley D, Cupertino AP. Effectiveness of Recruitment Strategies of Latino Smokers: Secondary Analysis of a Mobile Health Smoking Cessation Randomized Clinical Trial. J Med Internet Res. 2022 Jun 27;24(6):e34863. doi: 10.2196/34863.

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MeSH Terms

Conditions

Smoking Cessation; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Ana Paula Cupertino, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: September 1, 2018
• Primary Completion: September 8, 2021
• Study Completion: September 8, 2021
• Last Updated: April 12, 2024

Record last verified: 2024-04

Locations

US (3)