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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

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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 smoke at least 5 cigarettes daily.

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I am between 18 and 64 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the span of the final phase of study (2 years)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of intervention - delivery of AAC

Acceptability of intervention - referral rate

Change in provider attitudes

+20 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

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.

0 / 3Eligibility criteria met