Smoking Cessation Program for Tobacco-Related Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Amy Ferketich, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase IV trial examines the effectiveness of a multi-level smoking cessation program for high-risk women in rural communities. Cigarette smoking is a major risk factor for cervical cancer in women. Rural primary care practices and providers often lack the electronic health record support to pre-identify smokers for services, as well as lack the necessary counseling training and access to comprehensive cessation programs. Implementing evidence-based smoking cessation programs in rural Appalachia may decrease the rates of cigarette smoking and as a result decrease the rates of cervical cancer.

Research Team

Amy Ferketich, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I'm sorry, could you please provide more context or information about this criterion? It seems incomplete.

I provide care to women who smoke.

I am female.

Treatment Details

Interventions

• Multi-Level Smoking Cessation Program (Behavioural Intervention)

Trial Overview 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.

Participant Groups

Group I: Arm I (early arm) Experimental Treatment 3 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 Control 4 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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Interim Chief Executive Officer since 2022

MD, MBA

Dr. David Cohn

Ohio State University Comprehensive Cancer Center

Chief Medical Officer since 2018

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School