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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

810 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-30

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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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

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Tobacco-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Survey Administration

Intervention Type OTHER

Ancillary studies

Tobacco Cessation Counseling

Intervention Type OTHER

Receive referred to counseling session

Tobacco Cessation Counseling

Intervention Type OTHER

Receive phone counseling

Training

Intervention Type OTHER

Undergo training

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.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive usual care

Survey Administration

Intervention Type OTHER

Ancillary studies

Tobacco Cessation Counseling

Intervention Type OTHER

Receive referred to counseling session

Tobacco Cessation Counseling

Intervention Type OTHER

Receive phone counseling

Training

Intervention Type OTHER

Undergo training

Interventions

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Best Practice

Receive usual care

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Tobacco Cessation Counseling

Receive referred to counseling session

Intervention Type OTHER

Tobacco Cessation Counseling

Receive phone counseling

Intervention Type OTHER

Training

Undergo training

Intervention Type OTHER

Other Intervention Names

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standard of care standard therapy Training Programs

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes