Tobacco Cessation Counseling for Tobacco-Related Cancer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Virginia, Charlottesville, VATobacco-Related CancerTobacco Cessation Counseling - Other
Eligibility
18 - 64
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether a smoking cessation program can help high-risk women in rural communities quit smoking. Cigarette smoking is a major risk factor for cervical cancer in women, and these programs may help reduce rates of smoking and cervical cancer.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

23 Primary · 0 Secondary · Reporting Duration: During the span of the final phase of study (2 years)

Month 12
Effectiveness of intervention at increasing brief cessation counseling: Change over time
Month 6
Smoker satisfaction after Break Free program
Year 1
Prolonged abstinence
Year 1
Smoker satisfaction during Break Free counseling
Smoker satisfaction with Break Free counseling
At time of in person visit for a one week span, every other month during the span of the intervention (one year)
Fidelity to the intervention: provider visits
Year 1
Change in provider attitudes
Change in provider's normative beliefs
Change in provider's perceived behavioral control
Effectiveness of intervention of Improved provider knowledge and attitude
Year 1
Change in provider knowledge
Day after phone counseling during the span of the intervention (one year)
Fidelity to the intervention: counseling calls
Year 2
Sustainability of the intervention: EHR documentation
Sustainability of the intervention: clinic continuation of Break Free
Sustainability of the intervention: counseling sessions
Smoke
Year 1
Provider satisfaction
Staff satisfaction
Up to 6 months
Acceptability of intervention - delivery of AAC
Acceptability of intervention - referral rate
Cost-effectiveness of intervention
Up to 7 days
Floating abstinence
Point prevalence

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Arm II (delayed arm)
1 of 2
Arm I (early arm)
1 of 2

Active Control

Experimental Treatment

810 Total Participants · 2 Treatment Groups

Primary Treatment: Tobacco Cessation Counseling · No Placebo Group · Phase 4

Arm I (early arm)Experimental Group · 3 Interventions: Tobacco Cessation Counseling, Survey Administration, Training · Intervention Types: Other, Other, Other
Arm II (delayed arm)ActiveComparator Group · 4 Interventions: Best Practice, Tobacco Cessation Counseling, Survey Administration, Training · Intervention Types: Other, Other, Other, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during the span of the final phase of study (2 years)

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
290 Previous Clinical Trials
285,329 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,156 Previous Clinical Trials
41,162,790 Total Patients Enrolled
Amy Ferketich, PhDPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center

Eligibility Criteria

Age 18 - 64 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
I'm sorry, but "HEALTH SYSTEM/CLINIC" is not a criterion. Could you please provide more context or information?
You live in one of the Appalachian areas included in this study.
I'm sorry, could you please provide more context or information about this criterion? It seems incomplete.
I'm sorry, but the criterion you provided is incomplete. Please provide the full criterion so I can summarize it for you.
Women
You must be between 18 and 64 years old.
You smoke at least 5 cigarettes a day, even though it's not enough for most quit-smoking studies.
Only female smokers are eligible for the study.
You receive medical care from one of the healthcare systems involved in the study.
You are a healthcare provider who takes care of patients.

Who else is applying?

What state do they live in?
Illinois100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

Are there currently any opportunities to join this experiment?

"Verified; this clinical trial is currently accepting participants. Its initial posting on January 30th, 2021 has been followed by a most recent update occurring April 23rd 2022, as indicated in the records hosted on clinicaltrials.gov." - Anonymous Online Contributor

Unverified Answer

Do I meet the qualifications to join this research program?

"This clinical trial seeks 810 female patients, aged 18 to 64, with a diagnosis of tobacco-related carcinoma. Eligibility requirements limit enrollees to those coming from qualified Appalachian health systems and who are receiving care by a participating provider. Additionally, participants must be smokers that consume at least 5 cigarettes daily for an indication of nicotine dependence." - Anonymous Online Contributor

Unverified Answer

Does this trial permit individuals aged 40 or older to participate?

"According to the requirements for participation, eligible candidates must be between 18 and 64 years of age." - Anonymous Online Contributor

Unverified Answer

Has the FDA given its seal of approval to Tobacco Cessation Counseling?

"The safety of Tobacco Cessation Counseling was rated a 3 on our Power scale as it has been approved and is in its fourth phase of clinical trials." - Anonymous Online Contributor

Unverified Answer

To what extent is this clinical trial being administered to participants?

"This medical trial requires 810 suitable participants, who meet the established prerequisite criteria. Potential enrollees can present themselves for inclusion at West Virginia University in Morgantown or Ohio State University Comprehensive Cancer Center in Columbus, Ohio." - Anonymous Online Contributor

Unverified Answer

How prevalent is the implementation of this research in American healthcare facilities?

"This scientific investigation is open to participants from West Virginia University, Ohio State University Comprehensive Cancer Center, and the University of Kentucky/Markey Cancer Centre. Additionally, there are 4 other clinical trial sites accepting patients." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.