Enhancing long-term smoking abstinence among individuals with a history of cervical intraepithelial neoplasia or cervical cancer (Project ACCESS): protocol for a randomized clinical trial

BMC Public Health

Study Protocol

Sarah R. Jones¹  Bethany Shorey Fennell¹  Charles E. Hoogland¹  Damon J. Vidrine²  Vani N. Simmons³  Jennifer I. Vidrine³  Steven K. Sutton⁴  Honor W. Woodward⁵ 

[1] Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 Magnolia Dr, 33612, Tampa, FL, USA;Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 Magnolia Dr, 33612, Tampa, FL, USA;Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL, USA;Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 Magnolia Dr, 33612, Tampa, FL, USA;Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL, USA;Department of Psychology, University of South Florida, Tampa, FL, USA;Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 Magnolia Dr, 33612, Tampa, FL, USA;Department of Oncologic Sciences, Morsani College of Medicine, University of South Florida, Tampa, FL, USA;Department of Psychology, University of South Florida, Tampa, FL, USA;Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, FL, USA;Department of Health Outcomes and Behavior, Moffitt Cancer Center, 12902 Magnolia Dr, 33612, Tampa, FL, USA;Department of Psychology, University of South Florida, Tampa, FL, USA;

关键词: Cervical cancer;    Cervical intraepithelial neoplasia;    Cervical dysplasia;    Cancer;    Smoking;    Smoking cessation;    Tobacco cessation;   

DOI  :  10.1186/s12889-023-16189-3

 received in 2023-05-30, accepted in 2023-06-25,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundThe prevalence of smoking among cervical cancer survivors is high and evidence-based smoking cessation interventions are critically needed. This paper describes the study design, methods, and data analysis plans for a randomized clinical trial (RCT) designed to evaluate the efficacy of a novel, personally tailored SMS-delivered text-based digital treatment adjuvant designed to enhance the long-term efficacy of a “Motivation And Problem-Solving” (MAPS) approach for smoking cessation among individuals with a history of cervical intraepithelial neoplasia (CIN) or cervical cancer. MAPS is a phone counseling approach designed to facilitate long-term abstinence that comprises 6 counseling calls over 12 months. The current trial is evaluating the efficacy of MAPS+, which comprises all MAPS components plus a 24-month digital treatment adjuvant. This trial represents a logical extension of our previous RCT, which compared the efficacy of MAPS to a quitline control condition and found that MAPS resulted in greater than a 2-fold increase in smoking abstinence at 12 months (i.e., 26.4% vs. 11.9%). This treatment effect was no longer significant at 18 months, suggesting that efficacy dissipated as time from the end of treatment increased. The primary aim of the current trial is to compare the efficacy of MAPS + and ST in facilitating long-term abstinence.MethodsIndividuals who smoke and have a history of cervical cancer or CIN (N = 340) are recruited throughout Florida and randomly assigned to Standard Treatment [ST] or MAPS+. ST participants are electronically connected with the Florida Quitline. MAPS + consists of 6 proactive MAPS-based counseling calls over 12 months plus the novel, personally tailored, text message-based treatment adjuvant delivered over 24 months. All participants receive 12 weeks of combination nicotine replacement therapy (patch and lozenge) and are followed for 24 months. Participant recruitment commenced in December 2022 and is ongoing.DiscussionThis study builds on promising results from our recent trial which found that MAPS was associated with substantially higher abstinence from smoking at the end of the 12-month treatment period. Finding that this low-burden, personally tailored digital treatment adjuvant improves the long-term efficacy of MAPS would have important clinical and public health implications.Trial registrationClinical Trials Registry NCT05645146; https://clinicaltrials.gov/ct2/show/NCT05645146; Registered on December 9, 2022.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

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