Tobacco-Related CarcinomaNCT04340531
Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities
A study testing Best Practice, Survey Administration and Tobacco Cessation Counseling in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco-Related Carcinoma
- What is being tested?
- Best Practice, Survey Administration and Tobacco Cessation Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 810 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Jan 2021to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia
Charlottesville, Virginia, 22908
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Tobacco-Related Carcinoma
- Being tested
- Best Practice, Survey Administration, Tobacco Cessation Counseling, Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Survey AdministrationOther
Ancillary studies
Tobacco Cessation CounselingOther
Receive referred to counseling session
Tobacco Cessation CounselingOther
Receive phone counseling
TrainingOther
Also called Training Programs
Undergo training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Best Practice; Other: Survey Administration; Other: Tobacco Cessation Counseling; Other: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention - delivery of AAC
This provider-level outcome includes self-reported changes in the delivery of the Ask, Advise, and Connect (AAC).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days
Floating abstinence
Defined as not smoking during any consecutive 7-day period since the last assessment. Self-reported by patients.
Measured: Up to 7 days
Prolonged abstinence
Defined as no smoking after a two-week grace period from the quit date. Self-reported by patients.
Measured: At each follow-up visit over the span of the intervention (1 year)
Provider satisfaction
Measured via provider surveys
Measured: Mid-points of each provider arm during the intervention year (1 year)
Staff satisfaction
Measured via staff surveys
Measured: Mid-points of each provider arm during the intervention year (1 year)
Smoker satisfaction with Break Free counseling
Measured via patient surveys
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, post-training (1 day), 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start30 Jan 2021
- Primary completion13 Mar 2025
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco-Related CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 810 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Amy Ferketich, Ohio State University Comprehensive Cancer Center
- Investigators
- Amy Ferketich, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340531
- Sponsor's protocol ID
- OSU-20056
- Other IDs
- NCI-2020-01403, P01CA229143
- Status last verified
- Apr 2025
- First submitted
- 24 Mar 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35164857
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Break Free: Effectiveness of a Multi-Level Smoking Cessation Program Adapted for High-Risk Women in Rural Communities
- ClinicalTrials.gov ID
- NCT04340531
- Acronym / sponsor ID
- OSU-20056
- Conditions
- Tobacco-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 810 participants (estimated)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 13 Mar 2025 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 9 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (early arm) | Experimental | Other: Survey Administration, Other: Tobacco Cessation Counseling, Other: TrainingProviders 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) | Active comparator | Other: Best Practice, Other: Survey Administration, Other: Tobacco Cessation Counseling, Other: TrainingFemale 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 may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm II (delayed arm) |
| Survey AdministrationAncillary studies | Other | Arm I (early arm), Arm II (delayed arm) |
| Tobacco Cessation CounselingReceive referred to counseling session | Other | Arm I (early arm), Arm II (delayed arm) |
| Tobacco Cessation CounselingReceive phone counseling | Other | Arm I (early arm), Arm II (delayed arm) |
| TrainingAlso: Training ProgramsUndergo training | Other | Arm I (early arm), Arm II (delayed arm) |
Primary outcome
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).
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
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.
Provider satisfaction
Time frame: Mid-points of each provider arm during the intervention year (1 year)
Measured via provider surveys
Staff satisfaction
Time frame: Mid-points of each provider arm during the intervention year (1 year)
Measured via staff surveys
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
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
Smoker satisfaction after Break Free program
Time frame: At 6 months after completion of Break Free counseling
Measured via patient surveys
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Derived from this study: PubMed 35164857Patterson 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.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Ferketich, PhD principal investigator
Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Survey Administration and Tobacco Cessation Counseling in people with Tobacco-Related Carcinoma, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention - delivery of AAC (time frame: Up to 6 months). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04340531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.