. 2022 Feb 14;17(1):11.

doi: 10.1186/s13722-022-00295-5.

A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program

Joanne G Patterson^{1

2}, Tia N Borger³, Jessica L Burris³, Mark Conaway⁴, Robert Klesges^{4

5}, Amie Ashcraft⁶, Lindsay Hauser⁷, Connie Clark⁷, Lauren Wright⁶, Sarah Cooper⁸, Merry C Smith⁸, Mark Dignan^{9

10}, Stephenie Kennedy-Rea^{11

12}, Electra D Paskett^{13

14

15}, Roger Anderson^{4

5}, Amy K Ferketich^{13

14}

Affiliations

¹ Division of Epidemiology, College of Public Health, The Ohio State University, 354 Cunz Hall, 1841 Neil Avenue, Columbus, OH, 43210, USA. patterson.1191@osu.edu.
² The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA. patterson.1191@osu.edu.
³ Department of Psychology, University of Kentucky, Lexington, KY, USA.
⁴ Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
⁵ School of Medicine, University of Virginia, Charlottesville, VA, USA.
⁶ West Virginia University, Morgantown, WV, USA.
⁷ UVA Cancer Center, University of Virginia, Charlottesville, VA, USA.
⁸ College of Public Health, The Ohio State University, Columbus, OH, USA.
⁹ Department of Internal Medicine, College of Medicine, University of Kentucky, Lexington, KY, USA.
¹⁰ Markey Cancer Center, University of Kentucky, Lexington, KY, USA.
¹¹ West Virginia University Cancer Institute, Morgantown, WV, USA.
¹² Department of Medicine, School of Medicine, West Virginia University, Morgantown, WV, USA.
¹³ Division of Epidemiology, College of Public Health, The Ohio State University, 354 Cunz Hall, 1841 Neil Avenue, Columbus, OH, 43210, USA.
¹⁴ The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.
¹⁵ Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA.

PMID: 35164857
PMCID: PMC8842942
DOI: 10.1186/s13722-022-00295-5

A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program

Joanne G Patterson et al. Addict Sci Clin Pract. 2022.

. 2022 Feb 14;17(1):11.

doi: 10.1186/s13722-022-00295-5.

Authors

Affiliations

¹ Division of Epidemiology, College of Public Health, The Ohio State University, 354 Cunz Hall, 1841 Neil Avenue, Columbus, OH, 43210, USA. patterson.1191@osu.edu.
² The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA. patterson.1191@osu.edu.
³ Department of Psychology, University of Kentucky, Lexington, KY, USA.
⁴ Department of Public Health Sciences, University of Virginia, Charlottesville, VA, USA.
⁵ School of Medicine, University of Virginia, Charlottesville, VA, USA.
⁶ West Virginia University, Morgantown, WV, USA.
⁷ UVA Cancer Center, University of Virginia, Charlottesville, VA, USA.
⁸ College of Public Health, The Ohio State University, Columbus, OH, USA.
⁹ Department of Internal Medicine, College of Medicine, University of Kentucky, Lexington, KY, USA.
¹⁰ Markey Cancer Center, University of Kentucky, Lexington, KY, USA.
¹¹ West Virginia University Cancer Institute, Morgantown, WV, USA.
¹² Department of Medicine, School of Medicine, West Virginia University, Morgantown, WV, USA.
¹³ Division of Epidemiology, College of Public Health, The Ohio State University, 354 Cunz Hall, 1841 Neil Avenue, Columbus, OH, 43210, USA.
¹⁴ The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.
¹⁵ Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, The Ohio State University, Columbus, OH, USA.

PMID: 35164857
PMCID: PMC8842942
DOI: 10.1186/s13722-022-00295-5

Erratum in

Correction to: A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program.
Patterson JG, Borger TN, Burris JL, Conaway M, Klesges R, Ashcraft A, Hauser L, Clark C, Wright L, Cooper S, Smith MC, Dignan M, Kennedy-Rea S, Paskett ED, Anderson R, Ferketich AK. Patterson JG, et al. Addict Sci Clin Pract. 2022 Apr 1;17(1):21. doi: 10.1186/s13722-022-00304-7. Addict Sci Clin Pract. 2022. PMID: 35361240 Free PMC article. No abstract available.

Abstract

Background: The cervical cancer burden is high among women living in Appalachia. Cigarette smoking, a cervical cancer risk factor, is also highly prevalent in this population. This project aims to increase smoking cessation among women living in Appalachia by embedding a smoking cessation program within a larger, integrated cervical cancer prevention program.

Methods: The broader program, the Take CARE study, is a multi-site research collaborative designed to address three risk factors for cervical cancer incidence and mortality: tobacco use, human papillomavirus (HPV) infection, and cervical cancer screening. Break Free is a primary care clinic-based implementation program that aims to promote smoking cessation among female smokers in Appalachia by standardizing clinical practice protocols. Break Free includes: (1) implementation of a tobacco user identification system in the Electronic Health Record, (2) clinic staff and provider training on the Ask, Advise and Refer (AAR) model, (3) provider implementation of AAR to identify and treat women who want to quit smoking within the next 6 months, (4) facilitated access to cessation phone counseling plus pharmacotherapy, and (5) the bundling of Break Free tobacco cessation with HPV vaccination and cervical cancer screening interventions in an integrated approach to cervical cancer prevention. The study spans 35 Appalachian health clinics across 10 healthcare systems. We aim to enroll 51 adult female smokers per health system (total N = 510). Baseline and follow-up data will be obtained from participant (provider and patient) surveys. The primary outcome is self-reported 12-month point prevalence abstinence among enrolled patients. All randomized patients are asked to complete follow-up surveys, regardless of whether they participated in tobacco treatment. Data analysis of the primary aims will follow intent-to-treat methodology. Secondary outcomes will assess program implementation and cost effectiveness.

Discussion: Addressing high tobacco use rates is critical for reducing cervical cancer morbidity and mortality among women living in Appalachia. This study evaluates the implementation and effectiveness of a smoking cessation program in increasing smoking cessation among female smokers. If results demonstrate effectiveness and sustainability, implementation of this program into other health care clinics could reduce both rates of smoking and cervical cancer. Trial registration NCT04340531 (April 9, 2020).

Keywords: Cervical cancer prevention; Clinic-based interventions; Implementation science; Rural health; Smoking cessation.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

**Fig. 1**
*Break Free* program components

**Fig. 2**
Hybrid implementation-effectiveness study design

**Fig. 3**
Early Intervention Process Map

See this image and copyright information in PMC

References

1. Appalachia’s population (2014–2018). https://www.arc.gov/report/appalachias-population-2014-2018/.
1. Lengerich EJ, Tucker TC, Powell RK, Colsher P, Lehman E, Ward AJ, Siedlecki JC, Wyatt SW. Cancer incidence in Kentucky, Pennsylvania, and West Virginia: disparities in Appalachia. J Rural Health. 2005;1:39–47. - PubMed
1. The Appalachia Community Cancer Network: The cancer burden in Appalachia. 2009.
1. Wilson RJ, Ryerson AB, Singh SD, King JB. Cancer incidence in Appalachia, 2004–2011. Cancer Epidemiol Biomark Prev. 2016;25(2):250–258. - PMC - PubMed
1. Adegoke O, Kulasingam S, Virnig B. Cervical cancer trends in the United States: a 35-year population-based analysis. J Womens Health. 2012;21(10):1031–1037. - PMC - PubMed

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A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program

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A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program

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