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

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Best Practice; Other: Survey Administration; Other: Tobacco Cessation Counseling; Other: Tobacco Cessation Counseling; Other: Training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 810
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ohio State Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky/Markey Cancer Center
      • Contact: Mark Dingnan, PhD, MPH; Phone Number: 859-323-4708; Email: mbdign2@email.uky.edu
      • Principal Investigator: Mark Dingnan, PhD, MPH
      • Contact: Mark Cromo; Email: mark.cromo@uky.edu
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Amy Ferketich, PhD; Phone Number: 614-292-7326; Email: ferketich.1@osu.edu
      • Principal Investigator: Amy Ferketich, PhD
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia
      • Contact: Melissa Little, PhD, MPH; Phone Number: 434-964-4671; Email: mlittle@virginia.edu
      • Principal Investigator: Melissa Little, PhD, MPH
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • Recruiting
      • West Virginia University
      • Contact: Amie Ashcraft, PhD, MPH; Phone Number: 304-581-1646; Email: amashcraft@hsc.wvu.edu
      • Principal Investigator: Amie Ashcraft, PhD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: Training Programs
Active Comparator: 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.	Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; 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; Other Names: Training Programs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Amy Ferketich, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

General Publications

• 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. Erratum In: Addict Sci Clin Pract. 2022 Apr 1;17(1):21.

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: April 8, 2020
• First Posted (Actual): April 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: OSU-20056; P01CA229143 (U.S. NIH Grant/Contract); NCI-2020-01403 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No