Thomas H Brandon1, Vani N Simmons2, Steven K Sutton3, Marina Unrod2, Paul T Harrell4, Cathy D Meade2, Benjamin M Craig2, Ji-Hyun Lee5, Lauren R Meltzer2. 1. Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. Electronic address: thomas.brandon@moffitt.org. 2. Department of Health Outcomes and Behavior, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. 3. Department of Biostatistics and Bioinformatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida. 4. Department of Pediatrics, Eastern Virginia Medical School, Norfolk, Virginia. 5. Division of Epidemiology and Biostatistics, University of New Mexico Cancer Center, Albuquerque, New Mexico.
Abstract
INTRODUCTION: Far too few smokers receive recommended interventions at their healthcare visits, highlighting the importance of identifying effective, low-cost smoking interventions that can be readily delivered. Self-help interventions (e.g., written materials) would meet this need, but they have shown low efficacy. The purpose of this RCT was to determine the efficacy of a self-help intervention with increased duration and intensity. DESIGN: Randomized parallel trial design involving enrollment between April 2010 and August 2011 with follow-up data for 24 months. SETTING/PARTICIPANTS: U.S. national sample of daily smokers (N=1,874). INTERVENTION: Participants were randomized to one of three arms of a parallel trial design: Traditional Self-Help (TSH, n=638), Standard Repeated Mailings (SRM, n=614), or Intensive Repeated Mailings (IRM, n=622). TSH received an existing self-help booklet for quitting smoking. SRM received eight different cessation booklets mailed over a 12-month period. IRM received monthly mailings of ten booklets and additional material designed to enhance social support over 18 months. MAIN OUTCOME MEASURES: The primary outcome was 7-day point-prevalence abstinence collected at 6, 12, 18, and 24 months. RESULTS: Data were analyzed between 2013 and 2015. A dose-response effect was found across all four follow-up points. For example, by 24 months, IRM produced the highest abstinence rate (30.0%), followed by SRM (24.4%) and TSH (18.9%). The difference in 24-month abstinence rates between IRM and TSH was 11.0% (95% CI=5.7%, 16.3%). Cost analyses indicated that, compared with TSH, the incremental cost per quitter who received SRM and IRM was $560 and $361, respectively. CONCLUSIONS: Self-help interventions with increased intensity and duration resulted in significantly improved abstinence rates that extended 6 months beyond the end of the intervention. Despite the greater intensity, the interventions were highly cost effective, suggesting that widespread dissemination in healthcare settings could greatly enhance quitting. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01352195.
RCT Entities:
INTRODUCTION: Far too few smokers receive recommended interventions at their healthcare visits, highlighting the importance of identifying effective, low-cost smoking interventions that can be readily delivered. Self-help interventions (e.g., written materials) would meet this need, but they have shown low efficacy. The purpose of this RCT was to determine the efficacy of a self-help intervention with increased duration and intensity. DESIGN: Randomized parallel trial design involving enrollment between April 2010 and August 2011 with follow-up data for 24 months. SETTING/PARTICIPANTS: U.S. national sample of daily smokers (N=1,874). INTERVENTION: Participants were randomized to one of three arms of a parallel trial design: Traditional Self-Help (TSH, n=638), Standard Repeated Mailings (SRM, n=614), or Intensive Repeated Mailings (IRM, n=622). TSH received an existing self-help booklet for quitting smoking. SRM received eight different cessation booklets mailed over a 12-month period. IRM received monthly mailings of ten booklets and additional material designed to enhance social support over 18 months. MAIN OUTCOME MEASURES: The primary outcome was 7-day point-prevalence abstinence collected at 6, 12, 18, and 24 months. RESULTS: Data were analyzed between 2013 and 2015. A dose-response effect was found across all four follow-up points. For example, by 24 months, IRM produced the highest abstinence rate (30.0%), followed by SRM (24.4%) and TSH (18.9%). The difference in 24-month abstinence rates between IRM and TSH was 11.0% (95% CI=5.7%, 16.3%). Cost analyses indicated that, compared with TSH, the incremental cost per quitter who received SRM and IRM was $560 and $361, respectively. CONCLUSIONS: Self-help interventions with increased intensity and duration resulted in significantly improved abstinence rates that extended 6 months beyond the end of the intervention. Despite the greater intensity, the interventions were highly cost effective, suggesting that widespread dissemination in healthcare settings could greatly enhance quitting. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT01352195.
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