Clinical trial NCT04340531: Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities
Official title: Break Free: Effectiveness of a Multi-Level Smoking Cessation Program Adapted for High-Risk Women in Rural Communities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tobacco-Related Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-04-09
Enrollment: 810
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Acceptability of intervention - delivery of AAC
timeFrame: Up to 6 months
measure: Acceptability of intervention - referral rate
timeFrame: Up to 6 months
measure: Fidelity to the intervention: counseling calls
timeFrame: Day after phone counseling during the span of the intervention (one year)
measure: Fidelity to the intervention: provider visits
timeFrame: At time of in person visit for a one week span, every other month during the span of the intervention (one year)
measure: Sustainability of the intervention: clinic continuation of Break Free
timeFrame: During the span of the final phase of study (2 years)
measure: Sustainability of the intervention: counseling sessions
timeFrame: During the span of the final phase of study (2 years)
measure: Sustainability of the intervention: counseling sessions per smoker
timeFrame: During the span of the final phase of study (2 years)
measure: Sustainability of the intervention: EHR documentation
timeFrame: During the span of the final phase of study (2 years)
measure: Cost-effectiveness of intervention
timeFrame: Up to 6 months
measure: Effectiveness of intervention at increasing brief cessation counseling: Change over time
timeFrame: 3 months, 6 months, 12 months
measure: Point prevalence
timeFrame: Up to 7 days
measure: Floating abstinence
timeFrame: Up to 7 days
measure: Prolonged abstinence
timeFrame: At each follow-up visit over the span of the intervention (1 year)
measure: Provider satisfaction
timeFrame: Mid-points of each provider arm during the intervention year (1 year)
measure: Staff satisfaction
timeFrame: Mid-points of each provider arm during the intervention year (1 year)
measure: Smoker satisfaction with Break Free counseling
timeFrame: At the end of each Break Free counseling sessions during the intervention year (year 1)
measure: Smoker satisfaction during Break Free counseling
timeFrame: At the end of each Break Free counseling sessions during the intervention year (year 1)
measure: Smoker satisfaction after Break Free program
timeFrame: At 6 months after completion of Break Free counseling
measure: Change in provider knowledge
timeFrame: Baseline, post-training (same day), 1 year
measure: Change in provider attitudes
timeFrame: Baseline, post-training (1 day), 1 year
measure: Change in provider's normative beliefs
timeFrame: Baseline, post-training (1 day), 1 year
measure: Change in provider's perceived behavioral control
timeFrame: Baseline, post-training (1 day), 1 year
measure: Effectiveness of intervention of Improved provider knowledge and attitude
timeFrame: Baseline, post-training (1 day), 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky/Markey Cancer Center
state: Kentucky
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Amy Ferketich, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.