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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
Provides care to female smokers
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the span of the final phase of study (2 years)
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.

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 provide care to women who smoke.
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I am between 18 and 64 years old.
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I smoke at least 5 cigarettes daily.
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I am female.

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
13,579 Previous Clinical Trials
41,223,899 Total Patients Enrolled
Ohio State University Comprehensive Cancer CenterLead Sponsor
315 Previous Clinical Trials
288,831 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~202 spots leftby Feb 2025