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.

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).

Advancing engagement and capacity for rural cancer control: a mixed-methods case study of a Community-Academic Advisory Board in the Appalachia region of Southwest Virginia.

BACKGROUND: The objectives are to: 1) describe engagement processes used to prioritize and address regional comprehensive cancer control needs among a Community-Academic Advisory Board (CAB) in the medically-underserved, rural Appalachian region, and 2) detail longitudinal CAB evaluation findings. METHODS: This three-year case study (2017-2020) used a convergent parallel, mixed-methods design. The approach was guided by community-based participatory research (CBPR) principles, the Comprehensive Participatory Planning and Evaluation process, and Nine Habits of Successful Comprehensive Cancer Control Coalitions. Meeting artifacts were tracked and evaluated. CAB members completed quantitative surveys at three time points and semi-structured interviews at two time points. Quantitative data were analyzed using analysis of variance tests. Interviews were audio recorded, transcribed, and analyzed via an inductive-deductive process. RESULTS: Through 13 meetings, Prevention and Early Detection Action Teams created causal models and prioritized four cancer control needs: human papillomavirus vaccination, tobacco control, colorectal cancer screening, and lung cancer screening. These sub-groups also began advancing into planning and intervention proposal development phases. As rated by 49 involved CAB members, all habits significantly improved from Time 1 to Time 2 (i.e., communication, priority work plans, roles/accountability, shared decision making, value-added collaboration, empowered leadership, diversified funding, trust, satisfaction; all p < .05), and most remained significantly higher at Time 3. CAB members also identified specific challenges (e.g., fully utilizing member expertise), strengths (e.g., diverse membership), and recommendations across habits. CONCLUSION: This project's equity-based CBPR approach used a CPPE process in conjunction with internal evaluation of cancer coalition best practices to advance CAB efforts to address cancer disparities in rural Appalachia. This approach encouraged CAB buy-in and identified key strengths, weaknesses, and opportunities that will lay the foundation for continued involvement in cancer control projects. These engagement processes may serve as a template for similar coalitions in rural, underserved areas.

There has been notable progress among state and local cancer coalitions in developing and implementing comprehesive cancer control plans. Yet, gaps exist in rural communities and cancer remains a leading cause of death in rural populations. This paper reports on how the involvement of a Community-Academic Advisory Board (CAB) helped to prioritize cancer control and research needs in the medically-underserved, rural Appalachian region. CAB members were asked to participate in meetings and to share their experiences through surveys and interviews. Through this three-year process, four cancer control needs were prioritized: human papillomavirus vaccination, tobacco control, colorectal cancer screening, and lung cancer screening. Also, over the course of the project, CAB members' experiences improved, including: communication, priority work plans, roles/accountability, shared decision making, value-added collaboration, empowered leadership, diversified funding, trust, satisfaction. During the interviews, CAB members identified specific challenges, strengths, and recommendations. The opportunities and barriers at building and sustaining capacity as well as advancing a community-driven research agenda to address cancer disparities in rural Appalachia is discussed.

An Evaluation of the Process and Quality Improvement Measures of the University of Virginia Cancer Center Tobacco Treatment Program.

Tobacco use after a cancer diagnosis can increase risk of disease recurrence, increase the likelihood of a second primary cancer, and negatively impact treatment efficacy. The implementation of system-wide comprehensive tobacco cessation in the oncology setting has historically been low, with over half of cancer clinicians reporting that they do not treat or provide a referral to cessation resources. This quality improvement study evaluated the procedures for assessing and documenting tobacco use among cancer survivors and referring current smokers to cessation resources at the University of Virginia Cancer Center. Process mapping revealed 20 gaps across two major domains: electronic health record (EHR), and personnel barriers. The top identified priority was inconsistent documentation of tobacco use status as it impacted several downstream gaps. Eleven of the 20 gaps were deemed a high priority, and all were addressed during the implementation of the resulting Tobacco Treatment Program. Prioritized gaps were addressed using a combination of provider training, modifications to clinical workflow, and EHR modifications. Since implementation of solutions, the number of unique survivors receiving cessation treatment has increased from 284 survivors receiving cessation support during Year 1 of the initiative to 487 in Year 3. The resulting Tobacco Treatment Program provides a systematic, personalized, and sustainable comprehensive cessation program that optimizes the multifaceted workflow of the Cancer Center and has the potential to reduce tobacco use in a population most in need of cessation support.

Creating a Workplace Culture of Preventive Health: Process and Outcomes of the Colon Cancer-Free Zone at Virginia Cooperative Extension.

Colorectal cancer is the third leading cause of cancer death in the USA, yet is highly preventable and detectable at an early stage through screening. Virginia Cooperative Extension (VCE) implemented a worksite colon cancer awareness program to increase colorectal cancer screening rates and preventive lifestyle behaviors among its employees. The Colon Cancer-Free Zone program is designed using best practice principles of worksite health programs and includes information sessions covering the topics of colorectal cancer, screening guidelines, insurance coverage, and preventive lifestyle behaviors. It is conducted in a campaign format that includes a strategic communication strategy targeting relevant screening barriers and facilitators, peer champions, and incentives. The program was implemented with VCE employees statewide utilizing a web-based system for the information sessions, and resulted in broad participation, a significant increase in screening self-efficacy (4.15 ± 0.64 vs 3.81 ± 0.76, ρ = 0.006), changes in diet and physical activity (50% and 40% of participants, respectively), and a 20.6% increase in the employee colorectal cancer screening rate. A Colon Cancer-Free Zone toolkit was developed for use by Extension Agents to implement the program at worksites in their service communities.

Evaluation of a Clinical Cancer Trial Research Training Workshop: Helping Nurses Build Capacity in Southwest Virginia.

Residents of Southwest Virginia (SWVA) face significant barriers in accessing the most advanced forms of cancer care, cancer risk reduction, and clinical trials involvement. A collaboration between the University of Virginia (UVA) Cancer Center and UVA School of Nursing was forged with oncology caregivers in this region to build community capacity to support Cancer Clinical trials (CCT) by strengthening the workforce, and thus improving health outcomes for this underserved region of Appalachia. The UVA School of Nursing designed an educational workshop focusing on the basics of CCT to facilitate the development of a skilled nursing workforce in the SWVA region that could provide care to patients on protocol and/or to encourage residents to participate in trials. The goal of the workshop was to offer a CCT training session for oncology nurses that fostered the knowledge and skills necessary to facilitate and support CCT infrastructure across this high-risk region. This evaluation reports the learning outcomes of the CCT training on 32 nurse participants from SWVA. Evaluations of the training program showed high rates of satisfaction, increased comfort level with CCTs, and increased knowledge and attitude toward CCTs. These findings provide information about a curriculum that could be useful in educating other oncology nurses and student nurses how to care for patients who may be enrolled in a clinical trial. Nurses can also be advocates for participation in clinical trials once they have the knowledge and are comfortable in their own understanding of a trial's usefulness. Educating the nursing workforce is an essential component of building capacity and infrastructure to support clinical trials research.