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
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 pr...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-02-01
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| Series: | Addiction Science & Clinical Practice |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13722-022-00295-5 |
| _version_ | 1819281037021151232 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Joanne G. Patterson |
| collection | DOAJ |
| description | 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) |
| first_indexed | 2024-12-24T00:53:19Z |
| format | Article |
| id | doaj.art-7201ef13b4a4481d8584beda7c585d99 |
| institution | Directory Open Access Journal |
| issn | 1940-0640 |
| language | English |
| last_indexed | 2024-12-24T00:53:19Z |
| publishDate | 2022-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Addiction Science & Clinical Practice |
| spelling | doaj.art-7201ef13b4a4481d8584beda7c585d992022-12-21T17:23:32ZengBMCAddiction Science & Clinical Practice1940-06402022-02-0117111510.1186/s13722-022-00295-5A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the “Break Free” programJoanne G. Patterson0Tia N. Borger1Jessica L. Burris2Mark Conaway3Robert Klesges4Amie Ashcraft5Lindsay Hauser6Connie Clark7Lauren Wright8Sarah Cooper9Merry C. Smith10Mark Dignan11Stephenie Kennedy-Rea12Electra D. Paskett13Roger Anderson14Amy K. Ferketich15Division of Epidemiology, College of Public Health, The Ohio State UniversityDepartment of Psychology, University of KentuckyDepartment of Psychology, University of KentuckyDepartment of Public Health Sciences, University of VirginiaDepartment of Public Health Sciences, University of VirginiaWest Virginia UniversityUVA Cancer Center, University of VirginiaUVA Cancer Center, University of VirginiaWest Virginia UniversityCollege of Public Health, The Ohio State UniversityCollege of Public Health, The Ohio State UniversityDepartment of Internal Medicine, College of Medicine, University of KentuckyWest Virginia University Cancer InstituteDivision of Epidemiology, College of Public Health, The Ohio State UniversityDepartment of Public Health Sciences, University of VirginiaDivision of Epidemiology, College of Public Health, The Ohio State UniversityAbstract 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)https://doi.org/10.1186/s13722-022-00295-5Smoking cessationRural healthCervical cancer preventionImplementation scienceClinic-based interventions |
| spellingShingle | 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 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 Addiction Science & Clinical Practice Smoking cessation Rural health Cervical cancer prevention Implementation science Clinic-based interventions |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Smoking cessation Rural health Cervical cancer prevention Implementation science Clinic-based interventions |
| url | https://doi.org/10.1186/s13722-022-00295-5 |
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