Smoking Cessation Program for Tobacco-Related Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a Multi-Level Smoking Cessation Program designed to help women in rural areas quit smoking, thereby reducing the risk of cervical cancer. The program provides training and support to healthcare providers and offers in-person and phone counseling for women ready to quit smoking. It is open to female smokers in rural Appalachia who smoke at least five cigarettes a day and plan to quit within the next six months. Participants receive guidance on quitting and access to cessation treatments. As an unphased trial, this study allows participants to contribute to valuable research that could improve health outcomes for women in rural communities.

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 is the safety track record for the Multi-Level Smoking Cessation Program?

Research has shown that programs designed to help people quit smoking are safe and effective. One study found that quitting smoking significantly improves the chances of living longer, with benefits beginning as soon as three months after quitting. Another study revealed that even cancer patients who quit smoking experienced better treatment outcomes and a reduced risk of cancer recurrence. These findings suggest that the smoking cessation program used in this trial is generally well-received and can lead to positive health outcomes without major side effects. The program emphasizes counseling and support, which are crucial for successfully quitting smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this multi-level smoking cessation program because it combines personalized counseling with structured training for healthcare providers, offering a more comprehensive approach to quitting smoking. Unlike standard treatments that often focus solely on nicotine replacement or medications, this program emphasizes behavioral support through face-to-face and phone counseling sessions. By involving healthcare providers in the process, the treatment also aims to create a supportive environment that could enhance the effectiveness of smoking cessation efforts, especially for female smokers. This holistic approach could lead to more sustainable quitting outcomes compared to traditional methods.

What evidence suggests that this multi-level smoking cessation program is effective for reducing smoking and cervical cancer risk?

Research has shown that programs with varying levels of support can help women quit smoking. In this trial, participants in the early arm will receive in-person counseling and phone support, providing easy and helpful access. Meanwhile, participants in the delayed arm will initially receive usual care before accessing the same support. Evidence suggests that these programs not only aid in quitting smoking but also reduce the risk of smoking-related diseases, such as cervical cancer. They have proven especially effective in rural areas where healthcare access may be limited. ^{1 6 7 8 9}

Who Is on the Research Team?

Amy Ferketich, PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04340531

Effectiveness of a Multi-Level Smoking Cessation Program ... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35164857/

study protocol for the "Break Free" program - PubMed - NIH This study evaluates the implementation and effectiveness of a smoking cessation program in increasing smoking cessation among female smokers.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8842942/

A cluster randomized controlled trial for a multi-level, clinic ... This study evaluates the implementation and effectiveness of a smoking cessation program in increasing smoking cessation among female smokers.

4. researchgate.net researchgate.net/publication/358591725_A_cluster_randomized_controlled_trial_for_a_multi-level_clinic-based_smoking_cessation_program_with_women_in_Appalachian_communities_study_protocol_for_the_Break_Free_program

study protocol for the “Break Free” program A cluster randomized controlled trial for a multi-level, clinic-based smoking cessation program with women in Appalachian communities: study protocol for the “ ...

5. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2825372

Survival Outcomes of an Early Intervention Smoking ... This cohort study evaluates the survival outcomes of currently smoking patients with cancer who entered into a smoking cessation treatment program based.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169500225006452

An umbrella review of meta-analyses on smoking ... In lung cancer, quitting smoking reduces mortality by 15–29 %, with early-stage patients experiencing up to a 50 % reduction in risk of death. •. Similar ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528342/

Survival Outcomes of an Early Intervention Smoking ... Data also demonstrated that smoking cessation, regardless of time of entry, was associated with improved survival: abstinence at 3 months, 6 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10067126/

Engagement and outcomes of cancer patients referred to a ... Twenty‐four were able to cease tobacco use (25.8%). Only 7 patients out of the 101 patients (6.9%) who declined cessation services were ...

9. jto.org jto.org/article/S1556-0864(17)31357-6/pdf

MA 18.02 Outcomes of Integrating Smoking Cessation ... cancer diagnosis can result in improved treatment efficacy and safety, decreased risk of recurrence and second primary cancers, and lower mortality. Based ...