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

NCT04340531 | Active Not Recruiting DMC

• 3 other identifiers: OSU-20056NCI-2020-01403P01CA229143
• Study Type: interventional
• Target: 810
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Tobacco-Related Carcinoma

Outcome Measures

Primary Outcomes (23)

• Acceptability of intervention - delivery of AAC

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

  Up to 6 months

• Acceptability of intervention - referral rate

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

  Up to 6 months

• Fidelity to the intervention: counseling calls

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

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

• Fidelity to the intervention: provider visits

  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.

  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

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

  During the span of the final phase of study (2 years)

• Sustainability of the intervention: counseling sessions

  Measured by the number of counseling sessions billed for overall

  During the span of the final phase of study (2 years)

• Sustainability of the intervention: counseling sessions per smoker

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

  During the span of the final phase of study (2 years)

• Sustainability of the intervention: EHR documentation

  Measured by electronic health record documentation of tobacco use

  During the span of the final phase of study (2 years)

• Cost-effectiveness of intervention

  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.

  Up to 6 months

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

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

  3 months, 6 months, 12 months

• Point prevalence

  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.

  Up to 7 days

• Floating abstinence

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

  Up to 7 days

• Prolonged abstinence

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

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

• Provider satisfaction

  Measured via provider surveys

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

• Staff satisfaction

  Measured via staff surveys

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

• Smoker satisfaction with Break Free counseling

  Measured via patient surveys

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

• Smoker satisfaction during Break Free counseling

  Measured via patient surveys

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

• Smoker satisfaction after Break Free program

  Measured via patient surveys

  At 6 months after completion of Break Free counseling

• Change in provider knowledge

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

  Baseline, post-training (same day), 1 year

• Change in provider attitudes

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

  Baseline, post-training (1 day), 1 year

• Change in provider's normative beliefs

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

  Baseline, post-training (1 day), 1 year

• Change in provider's perceived behavioral control

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

  Baseline, post-training (1 day), 1 year

• Effectiveness of intervention of Improved provider knowledge and attitude

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

  Baseline, post-training (1 day), 1 year

Study Arms (2)

Arm I (early arm)

EXPERIMENTAL

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.

Other: Survey Administration; Other: Tobacco Cessation Counseling; Other: Training

Arm II (delayed arm)

ACTIVE COMPARATOR

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.

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

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Arm II (delayed arm)

Survey Administration OTHER

Ancillary studies

Arm I (early arm); Arm II (delayed arm)

Tobacco Cessation Counseling OTHER

Receive referred to counseling session

Arm I (early arm); Arm II (delayed arm)

Training OTHER

Undergo training

Also known as: Training Programs

Arm I (early arm); Arm II (delayed arm)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

Related Publications (1)

• Patterson JG, Borger TN, Burris JL, Conaway M, Klesges R, Ashcraft A, Hauser L, Clark C, Wright L, Cooper S, Smith MC, Dignan M, Kennedy-Rea S, Paskett ED, Anderson R, Ferketich AK. A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the "Break Free" program. Addict Sci Clin Pract. 2022 Feb 14;17(1):11. doi: 10.1186/s13722-022-00295-5.

  PMID: 35164857 DERIVED

Related Links

• The Jamesline

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Resistance Training

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Amy Ferketich, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: April 9, 2020
• Study Start: January 30, 2021
• Primary Completion: March 13, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)