NCT04340531

Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities

Break Free: Effectiveness of a Multi-Level Smoking Cessation Program Adapted for High-Risk Women in Rural Communities

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 810 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. 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. (Service outcomes) II. Determine satisfaction with the multilevel intervention. (Client outcomes) III. Test the sustainability of the multilevel intervention via training of providers and staff on counseling and billing for evidence-based smoking cessation services. (Implementation outcomes) OUTLINE: IMPLEMENTATION OF TOBACCO-USER IDENTIFICATION SYSTEM: Clinics and systems develop and implement minimally required electronic tracking and reporting systems for identification of smokers during months 1-12. GROUP RANDOMIZED TRIAL: Providers and participants are randomized to 1 of 2 arms. ARM I (EARLY ARM): Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 13-24. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist. ARM II (DELAYED ARM): Female smokers receive usual care during months 13-24. Providers undergo training over 60 minutes to explain the Break Free program and basics of quitting smoking during months 25-36. Female smokers interested in quitting in the next 6 months will be referred to an in-person counseling session at the clinic. Participants then receive 4 phone counseling over 15-20 minutes with a trained tobacco treatment specialist.

Conditions

• Tobacco-Related Carcinoma

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Survey Administration	Ancillary studies
OTHER	Tobacco Cessation Counseling	Receive referred to counseling session
OTHER	Tobacco Cessation Counseling	Receive phone counseling
OTHER	Training	Undergo training

Timeline

• Start date: 2021-01-30
• Primary completion: 2025-03-13
• Completion: 2026-05-31
• First posted: 2020-04-09
• Last updated: 2025-10-01

Locations

4 sites across 1 country: United States