Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04340531

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Tobacco-Related Carcinoma

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky/Markey Cancer Center, Lexington, Kentucky, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive usual care

Other names: standard of care, standard therapy

Survey Administration

Other

Ancillary studies

Tobacco Cessation Counseling

Other

Receive referred to counseling session

Training

Other

Undergo training

Other names: Training Programs

Primary outcomes

  1. Acceptability of intervention - delivery of AAC

    Time frame: Up to 6 months

    This provider-level outcome includes self-reported changes in the delivery of the Ask, Advise, and Connect (AAC).

  2. Acceptability of intervention - referral rate

    Time frame: Up to 6 months

    This provider-level outcome includes the rate of referrals to the in-clinic smoking cessation counselor.

  3. Fidelity to the intervention: counseling calls

    Time frame: Day after phone counseling during the span of the intervention (one year)

    Measured by asking 10% of randomly selected women questions about content of the phone counseling.

  4. Fidelity to the intervention: provider visits

    Time frame: At time of in person visit for a one week span, every other month during the span of the intervention (one year)

    Measured by self-administered, anonymous, post-provider visit surveys every other month by patients who were in the clinic for a visit during a one-week period. Patients will be asking whether the provider asked about tobacco use, if a smoker, advised the patient to quit, discussed cessation, and connected the smoker to counseling.

  5. Sustainability of the intervention: clinic continuation of Break Free

    Time frame: During the span of the final phase of study (2 years)

    Measured by self-reported continuation of cessation counseling by clinic staff

  6. Sustainability of the intervention: counseling sessions

    Time frame: During the span of the final phase of study (2 years)

    Measured by the number of counseling sessions billed for overall

  7. Sustainability of the intervention: counseling sessions per smoker

    Time frame: During the span of the final phase of study (2 years)

    Measured by the number of counseling sessions billed for each individual smoker who has at least one session

  8. Sustainability of the intervention: EHR documentation

    Time frame: During the span of the final phase of study (2 years)

    Measured by electronic health record documentation of tobacco use

  9. Cost-effectiveness of intervention

    Time frame: Up to 6 months

    Will be assessed using standard costs by considering costs of each component including pharmacotherapy, clinic counselor time and training, smoking cessation counselor time and training, telephone and material costs, and other administrative costs.

  10. Effectiveness of intervention at increasing brief cessation counseling: Change over time

    Time frame: 3 months, 6 months, 12 months

    Will be assessed using patient post-visit surveys and see if they increase over time.

  11. Point prevalence

    Time frame: Up to 7 days

    Measured using self-report of any tobacco use. Abstainers will be classified as those participants who self-report no use of tobacco during the past week.

  12. Floating abstinence

    Time frame: Up to 7 days

    Defined as not smoking during any consecutive 7-day period since the last assessment. Self-reported by patients.

  13. Prolonged abstinence

    Time frame: At each follow-up visit over the span of the intervention (1 year)

    Defined as no smoking after a two-week grace period from the quit date. Self-reported by patients.

  14. Provider satisfaction

    Time frame: Mid-points of each provider arm during the intervention year (1 year)

    Measured via provider surveys

  15. Staff satisfaction

    Time frame: Mid-points of each provider arm during the intervention year (1 year)

    Measured via staff surveys

  16. Smoker satisfaction with Break Free counseling

    Time frame: At the end of each Break Free counseling sessions during the intervention year (year 1)

    Measured via patient surveys

  17. Smoker satisfaction during Break Free counseling

    Time frame: At the end of each Break Free counseling sessions during the intervention year (year 1)

    Measured via patient surveys

  18. Smoker satisfaction after Break Free program

    Time frame: At 6 months after completion of Break Free counseling

    Measured via patient surveys

  19. Change in provider knowledge

    Time frame: Baseline, post-training (same day), 1 year

    Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on improved provider knowledge will be assessed.

  20. Change in provider attitudes

    Time frame: Baseline, post-training (1 day), 1 year

    Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on improved provider attitudes will be assessed.

  21. Change in provider's normative beliefs

    Time frame: Baseline, post-training (1 day), 1 year

    Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on provider's normative beliefs will be assessed.

  22. Change in provider's perceived behavioral control

    Time frame: Baseline, post-training (1 day), 1 year

    Using the Theory of Planned Behavior (TPB) model, effectiveness of intervention on provider's perceived behavioral control will be assessed.

  23. Effectiveness of intervention of Improved provider knowledge and attitude

    Time frame: Baseline, post-training (1 day), 1 year

    Using the Theory of Planned Behavior (TPB) model, attitudes, normative beliefs, and perceived behavioral control will be assessed.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 9, 2020
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.