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

Tobacco-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04340531
• Other study ID #: OSU-20056
• Secondary ID: NCI-2020-01403P0
• Status: Recruiting
• Phase: Phase 4
• Start date: January 30, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: Ohio State Comprehensive Cancer Center
• Phone: 800-293-5066
• Email: OSUCCCClinicaltrials[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco-Related Carcinoma

Intervention

Other:
• Best Practice
Receive usual care
• Survey Administration
Ancillary studies
• Tobacco Cessation Counseling
Receive referred to counseling session
• Tobacco Cessation Counseling
Receive phone counseling
• Training
Undergo training

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	University of Kentucky/Markey Cancer Center	Lexington	Kentucky
United States	West Virginia University	Morgantown	West Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	Floating abstinence	Defined as not smoking during any consecutive 7-day period since the last assessment. Self-reported by patients.	Up to 7 days
Primary	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)
Primary	Provider satisfaction	Measured via provider surveys	Mid-points of each provider arm during the intervention year (1 year)
Primary	Staff satisfaction	Measured via staff surveys	Mid-points of each provider arm during the intervention year (1 year)
Primary	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)
Primary	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)
Primary	Smoker satisfaction after Break Free program	Measured via patient surveys	At 6 months after completion of Break Free counseling
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

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