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

The Ohio State University

Status: Active, not recruiting

Conditions: Tobacco-Related Carcinoma

Treatments: Other: Best Practice; Other: Training; Other: Tobacco Cessation Counseling; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04340531

OSU-20056

NCI-2020-01403 (Registry Identifier)

P01CA229143 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 810 estimated patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• HEALTH SYSTEM/CLINIC
• Based in one of the Appalachian regions included in this program project
• Provides care to female smokers
• PROVIDER
• Practicing in one of the participating health systems
• Involved in patient care
• PATIENT
• Females
• Age 18 to 64
• Smokers who consume at least 5 cigarettes per day (less than the minimum in most cessation studies, yet still enough to show signs of nicotine dependence)
• Ready to quit smoking in the next 6 months
• English-speaking
• Able to participate in counseling
• Willing to try smoking cessation pharmacotherapy
• Not pregnant

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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810 participants in 2 patient groups

Arm I (early arm)

Experimental group

Description:

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.

Treatment:

Other: Survey Administration

Other: Tobacco Cessation Counseling

Other: Tobacco Cessation Counseling

Other: Training

Arm II (delayed arm)

Active Comparator group

Description:

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.

Treatment:

Other: Survey Administration

Other: Tobacco Cessation Counseling

Other: Tobacco Cessation Counseling

Other: Training

Other: Best Practice