Smoking Cessation Program for Tobacco-Related Cancer

Recruiting at 3 trial locations

Overseen By Ohio State Comprehensive Cancer Center

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Non-English speaking, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

810 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you must be willing to try smoking cessation medications.

What data supports the effectiveness of the treatment Multi-Level Smoking Cessation Program for patients with tobacco-related cancer?

Research shows that quitting smoking after a cancer diagnosis can improve treatment outcomes and survival rates. Patients with cancer are open to using standard methods for quitting smoking, and combining counseling and medication has been shown to help people quit smoking effectively. ^{1 2 3 4 5}

Is the Smoking Cessation Program for Tobacco-Related Cancer safe for humans?

The research does not provide specific safety data for the Smoking Cessation Program for Tobacco-Related Cancer, but it mentions that patients with cancer are receptive to standard evidence-based tobacco cessation guidelines, which suggests a general acceptance of safety in similar programs. ^{1 2 5 6 7}

How is the Multi-Level Smoking Cessation Program different from other treatments for tobacco-related cancer?

The Multi-Level Smoking Cessation Program is unique because it combines automatic referrals for tobacco users, motivational interviewing (a counseling approach to encourage quitting), and both behavioral and pharmacological interventions, with systematic follow-up calls to prevent relapse. This comprehensive approach is designed to improve success rates in quitting smoking and enhance overall health outcomes for cancer patients. ^{5 8 9 10 11}

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation of Tobacco-User Identification System

Clinics and systems develop and implement electronic tracking and reporting systems for identification of smokers

12 months

Group Randomized Trial - Early Arm

Providers undergo training and female smokers receive counseling sessions

12 months

1 in-person visit, 4 phone counseling sessions

Group Randomized Trial - Delayed Arm

Providers undergo training and female smokers receive counseling sessions

12 months

1 in-person visit, 4 phone counseling sessions

Follow-up

Participants are monitored for sustainability and effectiveness of the intervention

24 months

Treatment Details

Interventions

• Multi-Level Smoking Cessation Program

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+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Continued tobacco use after a cancer diagnosis significantly worsens treatment outcomes, increasing toxicity, recurrence, second tumors, and mortality rates among cancer patients.

Quitting smoking after a cancer diagnosis is associated with improved treatment outcomes, and patients are generally receptive to evidence-based cessation support, highlighting the need for better access and efficacy of cessation programs in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco use in the oncology setting: advancing clinical practice and research. Gritz, ER., Toll, BA., Warren, GW.[2022]

A randomized controlled trial involving 137 cancer patients found that a motivational interviewing intervention did not significantly increase smoking cessation rates compared to usual care, with both groups showing low quit rates at 6 months (5% for intervention vs. 6% for control).

However, a sensitivity analysis suggested that the intervention group had a higher quit rate (29%) compared to the control group (18%), indicating that while the intervention may not have been statistically significant, it could still have potential benefits that warrant further exploration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. Wakefield, M., Olver, I., Whitford, H., et al.[2022]

Tobacco use remains the largest preventable risk factor for cancer, and its continued use among cancer patients leads to worse health outcomes, highlighting the need for effective cessation support.

Integrating tobacco cessation support into lung cancer screening and treatment is feasible and can significantly improve patient health and treatment outcomes, yet most cancer patients currently do not receive this essential support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening, Cancer Treatment, and Addressing the Continuum of Health Risks Caused by Tobacco. Warren, GW., Ostroff, JS., Goffin, JR.[2023]

In a study involving 8144 participants, varenicline and bupropion were associated with specific adverse events (AEs) like nausea and insomnia compared to the nicotine patch, but overall, these treatments were well tolerated with less than 1.5% of participants experiencing severe AEs.

Most reported AEs were manageable and not clinically significant, allowing healthcare providers to reassure patients about the safety of these smoking cessation pharmacotherapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. Ebbert, J., Jimenez-Ruiz, C., Dutro, MP., et al.[2021]

The SCALE collaboration involves eight clinical trials aimed at improving smoking cessation strategies for older smokers (aged 55-80) with a significant smoking history, specifically in the context of lung cancer screening.

These trials address key methodological issues, such as participant eligibility and treatment delivery, to optimize smoking cessation outcomes and leverage the 'teachable moment' provided by lung cancer screening results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening and Smoking Cessation Clinical Trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration. Joseph, AM., Rothman, AJ., Almirall, D., et al.[2022]

In a study of 194 cancer patients referred to a tobacco cessation program, 47.9% accepted the referral, and among those, 25.8% successfully quit smoking, highlighting the program's potential effectiveness in supporting cancer patients in quitting tobacco.

Factors such as marital status and race influenced patients' acceptance of the referral, with single and Caucasian patients being less likely to engage, indicating the need for tailored approaches to improve participation in cessation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement and outcomes of cancer patients referred to a tobacco cessation program at a National Cancer Institute-designated cancer center. Westergaard, SA., Rupji, M., Franklin, LE., et al.[2023]

Tobacco use is a significant risk factor for cancer and negatively impacts cancer prognosis, yet effective cessation treatments are underutilized in oncology settings.

Implementing a comprehensive tobacco treatment program, which includes automatic referrals, motivational interviewing, and combined behavioral and pharmacological interventions, can significantly enhance smoking cessation success and improve health outcomes for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco Cessation in Oncology Care. Kaiser, EG., Prochaska, JJ., Kendra, MS.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Hospital-based tobacco treatment for inpatients with a history of cancer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Tobacco use in the oncology setting: advancing clinical practice and research. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing as a smoking cessation intervention for patients with cancer: randomized controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening, Cancer Treatment, and Addressing the Continuum of Health Risks Caused by Tobacco. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Patient Cessation Activity after Automatic Referral to a Dedicated Cessation Support Service. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Frequently Reported Adverse Events With Smoking Cessation Medications: Post Hoc Analysis of a Randomized Trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening and Smoking Cessation Clinical Trials. SCALE (Smoking Cessation within the Context of Lung Cancer Screening) Collaboration. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Point of care tobacco treatment sustains during COVID-19, a global pandemic. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Engagement and outcomes of cancer patients referred to a tobacco cessation program at a National Cancer Institute-designated cancer center. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Tobacco Cessation in Oncology Care. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

The impact of Thai multidisciplinary smoking cessation program on clinical outcomes: A multicentre prospective observational study. [2023]