System-level Tobacco Treatment Intervention for Smoking Cessation

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Hypercalcemia, Acute respiratory distress, others

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

Compensation: Varies

Number of Visits: 1

263 Participants Needed

Trial Summary

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment CEASE for smoking cessation?

Research shows that system-level changes in healthcare, like those used in CEASE, can help more people quit smoking by making sure they get the right support and treatments. These changes include using electronic health records to refer patients to quitlines and ensuring insurance covers smoking cessation treatments, which have been shown to increase quit rates. ^{1 2 3 4 5}

Is the System-level Tobacco Treatment Intervention for Smoking Cessation safe for humans?

The research articles reviewed do not provide specific safety data for the System-level Tobacco Treatment Intervention, CEASE, or Usual Care Tobacco Treatment Services. However, they emphasize the need for safer smoking cessation medications and interventions, suggesting that safety is a key consideration in developing new treatments. ^{4 6 7 8 9}

How is the CEASE treatment for smoking cessation different from other treatments?

The CEASE treatment is unique because it focuses on system-level changes within healthcare settings to integrate smoking cessation support into regular care, rather than just individual treatments. This approach aims to improve the overall provision and effectiveness of smoking cessation support by making it a routine part of healthcare services. ^{3 4 5 10 11}

What is the purpose of this trial?

The proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods.

Research Team

Mary E Cooley, PhD, RN

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for current or recent smokers (within the last 6 months) who are over 18, can read and write in English, and have or might have lung-related cancer. It's not for those who quit smoking more than 6 months ago or have urgent health issues like severe breathing problems, very low blood pressure, confusion from high calcium levels, or dehydration.

Inclusion Criteria

Able to read and write in English.

You have smoked within the past 6 months.

I have an active phone number.

Exclusion Criteria

I am experiencing severe breathing difficulties.

I am not dehydrated.

I quit smoking more than 6 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Implementation

Participants receive usual care and undergo baseline tobacco use surveys and biochemical verification

3 months

Baseline, 1-6 months

Implementation

Implementation of CEASE with exit interviews and tobacco use surveys

6 months

Exit interviews, ongoing surveys

Follow-up

Participants are monitored for smoking cessation and documentation of tobacco treatment

2 months

Treatment Details

Interventions

• CEASE
• Usual Care Tobacco Treatment Services

Trial Overview The study is testing how well a program called CEASE works when it's added to usual care that helps people stop smoking in a lung cancer treatment setting. Researchers will use different methods to see how effective this integration is compared to the standard support services.

Participant Groups

Group I: After Cease Implementation Aim 2 Experimental Treatment 1 Intervention

50 Current or former smokers (3 months +/-2 month) * Tobacco Use Survey (Baseline,1- 6 Months) * Biochemical verification

Group II: Cease-Aim 1 Active Control 1 Intervention

* Cease Implementation * 100 Patients after CEASE Implementation * Exit Interview and Tobacco Use Survey

Group III: Pre Cease Implementation Aim 2 Active Control 1 Intervention

50 Current or former smokers (3 months +/-2 month) patients in usual care (before CEASE implementation) * Tobacco Use Survey (Baseline,1- 6 Months) * Biochemical verification

Group IV: Usual Care-Aim 1 Active Control 1 Intervention

Usual Care Tobacco Treatment Services * 100 patients in usual care * Exit Interview and Tobacco Use Survey

Group V: Clinician and Staff Survey Active Control 1 Intervention

- Interview clinicians and support staff (40)

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Findings from Research

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]

In a study of 3,093 quit attempters from the US PATH Study, using electronic nicotine delivery systems (ENDS) was associated with a 6% increase in the likelihood of maintaining cigarette abstinence for at least 30 days, making it a popular cessation aid.

However, while ENDS helped some individuals quit, they did not significantly reduce daily cigarette consumption among those who relapsed, and pharmaceutical aids like varenicline and bupropion showed no substantial benefit in promoting persistent abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can E-Cigarettes and Pharmaceutical Aids Increase Smoking Cessation and Reduce Cigarette Consumption? Findings From a Nationally Representative Cohort of American Smokers. Benmarhnia, T., Pierce, JP., Leas, E., et al.[2023]

Smoking is the leading cause of premature death in Western countries, highlighting the urgent need for effective cessation methods to help smokers quit early.

Current and emerging therapies, including novel medications and vaccines, show promise in improving the efficacy and safety of smoking cessation treatments, with many in advanced stages of development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation: present status and future perspectives. Caponnetto, P., Russo, C., Polosa, R.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Electronic health record closed-loop referral ("eReferral") to a state tobacco quitline: a retrospective case study of primary care implementation challenges and adaptations. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Health system changes to facilitate the delivery of tobacco-dependence treatment. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Boosting population quits through evidence-based cessation treatment and policy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

System change interventions for smoking cessation. [2023]

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

The role of health care systems in increased tobacco cessation. [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

Can E-Cigarettes and Pharmaceutical Aids Increase Smoking Cessation and Reduce Cigarette Consumption? Findings From a Nationally Representative Cohort of American Smokers. [2023]

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

Beyond "Safe and Effective": The urgent need for high-impact smoking cessation medications. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Smoking cessation: present status and future perspectives. [2018]

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

Proactive Population Health Strategy to Offer Tobacco Dependence Treatment to Smokers in a Primary Care Practice Network. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Smokers' interest in using nicotine replacement to aid smoking reduction. [2022]