This phase IV trial examines the effectiveness of a multi-level smoking cessation program for high-risk women in rural communities. Cigarette smoking is a major risk factor for cervical cancer in women. Rural primary care practices and providers often lack the electronic health record support to pre-identify smokers for services, as well as lack the necessary counseling training and access to comprehensive cessation programs. Implementing evidence-based smoking cessation programs in rural Appalachia may decrease the rates of cigarette smoking and as a result decrease the rates of cervical cancer.
Age range
18 Years – 64 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Acceptability of intervention - delivery of AAC
Timeframe: Up to 6 months
Acceptability of intervention - referral rate
Timeframe: Up to 6 months
Fidelity to the intervention: counseling calls
Timeframe: Day after phone counseling during the span of the intervention (one year)
Fidelity to the intervention: provider visits
Timeframe: At time of in person visit for a one week span, every other month during the span of the intervention (one year)
Sustainability of the intervention: clinic continuation of Break Free
Timeframe: During the span of the final phase of study (2 years)
Sustainability of the intervention: counseling sessions
Timeframe: During the span of the final phase of study (2 years)
Sustainability of the intervention: counseling sessions per smoker
Timeframe: During the span of the final phase of study (2 years)
Sustainability of the intervention: EHR documentation
Timeframe: During the span of the final phase of study (2 years)
Cost-effectiveness of intervention
Timeframe: Up to 6 months
Effectiveness of intervention at increasing brief cessation counseling: Change over time
Timeframe: 3 months, 6 months, 12 months
Point prevalence
Timeframe: Up to 7 days
Floating abstinence
Timeframe: Up to 7 days
Prolonged abstinence
Timeframe: At each follow-up visit over the span of the intervention (1 year)
Provider satisfaction
Timeframe: Mid-points of each provider arm during the intervention year (1 year)
Staff satisfaction
Timeframe: Mid-points of each provider arm during the intervention year (1 year)
Smoker satisfaction with Break Free counseling
Timeframe: At the end of each Break Free counseling sessions during the intervention year (year 1)
Smoker satisfaction during Break Free counseling
Timeframe: At the end of each Break Free counseling sessions during the intervention year (year 1)
Smoker satisfaction after Break Free program
Timeframe: At 6 months after completion of Break Free counseling
Change in provider knowledge
Timeframe: Baseline, post-training (same day), 1 year
Change in provider attitudes
Timeframe: Baseline, post-training (1 day), 1 year
Change in provider's normative beliefs
Timeframe: Baseline, post-training (1 day), 1 year
Change in provider's perceived behavioral control
Timeframe: Baseline, post-training (1 day), 1 year
Effectiveness of intervention of Improved provider knowledge and attitude
Timeframe: Baseline, post-training (1 day), 1 year