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, Tia N. Borger, Jessica L. Burris, Mark Conaway, Robert Klesges, Amie Ashcraft, Lindsay Hauser, Connie Clark, Lauren Wright, Sarah Cooper, Merry C. Smith, Mark Dignan, Stephenie Kennedy-Rea, Electra D. Paskett, Roger Anderson, Amy K. Ferketich

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


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).

Original languageEnglish
Article number11
JournalAddiction Science and Clinical Practice
Issue number1
StatePublished - Dec 2022

Bibliographical note

Funding Information:
This study was funded by a grant from the National Cancer Institute (P01 CA229143), the Recruitment, Intervention and Survey Shared Resource at The Ohio State University Comprehensive Cancer Center (National Cancer Institute Grant P30 CA016058) and The Ohio State University Center for Clinical and Translational Science grant support (National Center for Advancing Translational Sciences, Grant UL1TR001070). This study was also supported by the National Cancer Institute under awards T32 CA229114 (JGP), K07 CA181351 (JLB), and P30 CA177558 (Patient Oriented and Population Sciences Shared Resource Facility; TNB). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The funders had no role in the design, collection, analysis, and interpretation of the data; in the writing of the manuscript; and in the decision to submit this manuscript for publication.

Publisher Copyright:
© 2022, The Author(s).


  • Cervical cancer prevention
  • Clinic-based interventions
  • Implementation science
  • Rural health
  • Smoking cessation

ASJC Scopus subject areas

  • Clinical Psychology
  • Psychiatry and Mental health


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