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Randomized Controlled Trial
. 2022 Mar 1;128(5):984-994.
doi: 10.1002/cncr.33986. Epub 2021 Oct 22.

Self-help smoking cessation intervention for Spanish-speaking Hispanics/Latinxs in the United States: A randomized controlled trial

Vani N Simmons  1   2   3 , Steven K Sutton  2   4   3 , Patricia Medina-Ramirez  1 , Ursula Martinez  1   2 , Karen O Brandon  1 , Margaret M Byrne  1   2 , Cathy D Meade  1   2 , Lauren R Meltzer  1 , Thomas H Brandon  1   2   3
Affiliations
Randomized Controlled Trial

Self-help smoking cessation intervention for Spanish-speaking Hispanics/Latinxs in the United States: A randomized controlled trial

Vani N Simmons et al. Cancer. .

Abstract

Background: Hispanic/Latinx smokers living in the United States face unique challenges in quitting smoking. This study evaluated the efficacy of a culturally relevant, Spanish-language, extended self-help smoking cessation intervention among Hispanic smokers.

Methods: A 2-arm parallel randomized controlled trial was conducted with Hispanic/Latinx smokers living in the United States who preferred health information in Spanish and smoked 5 or more cigarettes per week. Participants were randomly allocated to receive Libre del Cigarrillo (LDC), which consisted of 11 booklets and 9 pamphlets mailed monthly over 18 months, or the usual care (UC), which was a single Spanish-language self-help booklet from the National Cancer Institute. The primary outcome was self-reported 7-day point prevalence smoking abstinence assessed 6, 12, 18, and 24 months after the baseline. Eight prespecified moderators of the intervention were evaluated. Cost-effectiveness was also evaluated. All statistical tests were 2-sided.

Results: Data from all participants randomized to LDC (n = 714) or UC (n = 703) were used for analyses after multiple imputation to manage missing data. Generalized estimating equation analyses indicated that LDC abstinence rates were higher (P < .001) across all assessments. Logistic regression analyses revealed that at 24 months, the abstinence rate was greater for LDC (33.1%) than UC (24.3%; odds ratio, 1.54; 95% confidence interval, 1.18-2.02; P = .002). Men exhibited a strong intervention effect at all assessments (P values < .001), whereas the intervention effect for women was observed only at 6 and 12 months (P values < .018). In comparison with UC, the incremental cost per quitter in the LDC arm was $648.43 at 18 months and $683.93 at 24 months.

Conclusions: A culturally relevant, Spanish-language intervention was efficacious and cost-effective for smoking cessation.

Lay summary: Research is needed to develop interventions for ethnic minority smokers. The aim of the current study was to test a Spanish-language adaptation of a validated and easily implemented self-help smoking cessation intervention in a nationwide randomized controlled trial. The findings demonstrated that the intervention produced greater smoking abstinence in comparison with a standard self-help booklet. Participants also were more satisfied with the intervention, and it was cost-effective. Efforts aimed at promoting tobacco abstinence in this underserved population could have significant public health implications, including potential reductions in cancer health disparities associated with tobacco smoking.

Trial registration: ClinicalTrials.gov NCT02945787.

Keywords: Hispanic; Latino; Latinx; randomized controlled trial; self-help; smoking cessation.

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Conflict of interest statement

CONFLICT OF INTEREST DISCLOSURES

Vani N. Simmons reports payments to her institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program. Steven K. Sutton reports payments to his institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program. Patricia Medina-Ramirez reports payments to her institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program. Ursula Martinez reports payments to her institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program. Karen O. Brandon reports payments to her institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program. Margaret M. Byrne reports payments to her institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program. Cathy D. Meade reports payments to her institution from the National Cancer Institute and the Florida Department of Health. Lauren R. Meltzer reports payments to her institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program. Thomas H. Brandon has received research support from Pfizer, Inc, and is on the advisory board of Hava Health, Inc; he also reports payments to his institution from the National Institutes of Health and the Florida Department of Health James and Esther King Biomedical Research Program, consulting fees from the University at Buffalo, payments or honoraria from Florida International University, the University of Toronto, and the Roswell Park Comprehensive Cancer Center, and participation on a board for Yale University.

Figures

Figure 1.
Figure 1.
Consolidated Standards of Reporting Trials diagram. LDC indicates Libre del Cigarrillo; UC, usual care.
Figure 2.
Figure 2.
Seven-day point prevalence smoking abstinence rates. The percent abstinent was averaged across 20 multiple imputation data sets. The n value was 1417 for each of these complete data sets. Both treatments began at the baseline. Libre del Cigarrillo ended at 18 months. Abstinence rates at each assessment for both treatments are presented in Table 2 along with intervention odds ratios and P values from logistic regression at each assessment. Generalized estimating equations revealed a main effect for assessment and treatment condition (P values < .001).
Figure 3.
Figure 3.
Seven-day point prevalence smoking abstinence rates for men and women receiving the LDC and UC treatments. The percent abstinent was averaged across 20 multiple imputation data sets. The n value was 1417 for each of these complete data sets. Both treatments began at the baseline. LDC ended at 18 months. Abstinence rates at each assessment for both treatments are presented in Table 2 along with intervention odds ratios and P values from logistic regression at each assessment. Generalized estimating equations for each sex revealed a main effect for both assessment and treatment arm for men (P values < .001) and for women (P values < .05). LDC indicates Libre del Cigarrillo; UC, usual care.
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