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
Study Objectives
23 Primary · 0 Secondary · Reporting Duration: During the span of the final phase of study (2 years)
Trial Safety
Safety Progress
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
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 64 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Illinois | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
- Patterson, Joanne G., Tia N. Borger, Jessica L. Burris, Mark Conaway, Robert Klesges, Amie Ashcraft, Lindsay Hauser, et al.. 2022. “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”. Addiction Science & Clinical Practice. Springer Science and Business Media LLC. doi:10.1186/s13722-022-00295-5.
- 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.
- Amy Ferketich 2021. "Effectiveness of a Multi-Level Smoking Cessation Program for High-Risk Women in Rural Communities". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04340531.
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
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
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
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
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
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