# Project 1: Break Free:  Effectiveness of a multi-level smoking cessation program adapted for high-risk women in rural communities

> **NIH NIH P01** · OHIO STATE UNIVERSITY · 2022 · $186,573

## Abstract

PROJECT SUMMARY – PROJECT 1 
The prevalence of smoking (25 – 35%) in many underserved Appalachia communities is nearly double the 
national rate and is a major contributor to the high-risk for cervical cancer in the region. Project 1 – `Break Free' 
(BF) will implement and test the effectiveness of a healthcare provider- and trained patient navigator-delivered 
smoking cessation intervention designed to reduce cervical cancer risk within an integrated cervical cancer 
prevention program. BF is the result of previous work of the team in adapting an evidence-based smoking 
cessation program to rural populations and will be tested, refined and implemented to achieve high impact and 
sustainability through billable cost-recovery. BF utilizes a standard format of clinical delivery of Ask, Advise and 
Connect (AAC) followed by 4 sessions of proactive telephone-based counseling with Nicotine Replacement 
Therapy support delivered to 600 adult female smokers in primary care practices of 10 non-overlapping health 
systems in the Appalachian region of four states (KY, OH, VA, WV). BF will be extended to all eligible smokers 
in the sustainability phase. Delayed versus early intervention health system groups will be compared. Project 1 
is closely coordinated with the overall Program Project by providing a key component of an integrated cervical 
cancer risk reduction/prevention program and its overall outcome and will rely on its shared Cores for 
harmonization in its implementation, measurement, evaluation and dissemination processes. Project 1 aims are 
organized along three distinct levels of outcomes: 1) Service outcomes: Determine the effectiveness of a core 
component of an integrated cervical cancer prevention program designed to help female smokers quit by 
standardizing clinical practice supports and protocols; 2) Client outcomes: Determine satisfaction with the multi- 
level intervention; and 3) Implementation outcomes: Test the sustainability of the multi-level intervention via 
training of providers and staff on counseling and billing for evidence-based smoking cessation services. 
Successful implementation of BF in the diverse set of rural Appalachian clinics in participating health systems 
proposed, across 4 states, has the potential for a substantial and sustained impact by improving rural patients' 
access to high quality, culturally sensitive, and local evidence-based smoking cessation treatment. If successfully 
shown to be sustainable at the clinic level, BF could be disseminated widely within rural Appalachia, as well as 
to healthcare systems in other underserved geographic settings.

## Key facts

- **NIH application ID:** 10381630
- **Project number:** 5P01CA229143-04
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** Amy K Ferketich
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $186,573
- **Award type:** 5
- **Project period:** 2019-04-11 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10381630

## Citation

> US National Institutes of Health, RePORTER application 10381630, Project 1: Break Free:  Effectiveness of a multi-level smoking cessation program adapted for high-risk women in rural communities (5P01CA229143-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10381630. Licensed CC0.

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