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Smoking Cessation Program for Tobacco-Related Cancer

Phase 4
Recruiting
Led By Amy Ferketich, PhD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PROVIDER
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the span of the final phase of study (2 years)
Awards & highlights

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.

Who is the study for?
This trial is for women aged 18-64 who smoke at least 5 cigarettes daily and live in certain Appalachian regions. It's aimed at patients, healthcare providers, and clinics involved in caring for female smokers.Check my eligibility
What is being tested?
The study tests a smoking cessation program tailored for high-risk women in rural areas. It includes best practices, counseling training for providers, and survey administration to track effectiveness.See study design
What are the potential side effects?
Since this trial focuses on smoking cessation programs rather than medication or medical procedures, it does not have typical side effects. However, participants may experience nicotine withdrawal symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I'm sorry, could you please provide more context or information about this criterion? It seems incomplete.
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I smoke at least 5 cigarettes daily.
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I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the span of the final phase of study (2 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the span of the final phase of study (2 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of intervention - delivery of AAC
Acceptability of intervention - referral rate
Change in provider attitudes
+20 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (early arm)Experimental Treatment3 Interventions
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.
Group II: Arm II (delayed arm)Active Control4 Interventions
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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,591 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
325 Previous Clinical Trials
289,794 Total Patients Enrolled
Amy Ferketich, PhDPrincipal Investigator - Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center

Media Library

Multi-Level Smoking Cessation Program Clinical Trial Eligibility Overview. Trial Name: NCT04340531 — Phase 4
Tobacco-Related Cancer Research Study Groups: Arm II (delayed arm), Arm I (early arm)
Tobacco-Related Cancer Clinical Trial 2023: Multi-Level Smoking Cessation Program Highlights & Side Effects. Trial Name: NCT04340531 — Phase 4
Multi-Level Smoking Cessation Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340531 — Phase 4
~183 spots leftby Jul 2025
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