System-level Tobacco Treatment Intervention for Smoking Cessation

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of CEASE, a program designed to help people quit smoking, within the context of lung cancer care. It compares usual tobacco treatment services with the CEASE program to determine which better reduces smoking and exposure to secondhand smoke. Participants include current or recent smokers who might have or are suspected to have lung cancer and can communicate in English. Those who have smoked in the last six months and are dealing with lung-related health issues may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance lung cancer care and smoking cessation strategies.

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 prior data suggests that the CEASE intervention is safe for smoking cessation?

Research shows that the CEASE program aids doctors, such as pediatricians, in discussing smoking with families. This program trains medical staff to provide support and advice for quitting smoking. Studies have not identified any major safety issues with the CEASE program itself.

The program emphasizes education and support rather than medication or medical procedures, typically resulting in fewer risks. In similar programs, participants might experience frustration or stress while attempting to quit smoking, but these are normal challenges when changing habits.

Overall, the focus on counseling and support in the CEASE program indicates it is well-received, with no significant negative effects reported in the studies mentioned. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CEASE intervention for smoking cessation because it focuses on a system-level approach to improve outcomes. Unlike standard treatments that often rely on individual counseling or nicotine replacement therapies, CEASE integrates comprehensive tobacco treatment into usual healthcare settings, aiming to make quitting smoking a seamless part of regular medical care. This approach could increase accessibility and support for patients trying to quit, potentially leading to higher success rates in overcoming nicotine addiction. The trial also explores how implementation affects both patients and healthcare providers, offering insights into how systemic changes can enhance smoking cessation efforts.

What evidence suggests that the CEASE intervention could be effective for smoking cessation?

Research has shown that the CEASE program, one of the treatments in this trial, holds promise for helping people quit smoking. Earlier studies found CEASE to be cost-effective in 88% of cases, indicating it aids smoking cessation without high costs. Other research has demonstrated that programs like CEASE, which may include support such as text messages or counseling, can increase quitting success by up to 63%. This suggests CEASE could be a strong option for those attempting to stop smoking. Meanwhile, another group in this trial will receive Usual Care Tobacco Treatment Services, allowing for a comparison of effectiveness between the two approaches. ^{6 7 8 9 10}

Who Is on the Research Team?

Mary E Cooley, PhD, RN

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33792730/

Cost-effectiveness of a Smoking Cessation Intervention for ... CEASE was cost-effective at a willingness-to-pay threshold of $2000 per quit in 88.0% of simulations based on the parent-reported smoking prevalence.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8017473/

Cost-effectiveness of a Smoking Cessation Intervention for ... CEASE was cost-effective at a willingness-to-pay threshold of $2000 per quit in 88.0% of simulations based on the parent-reported smoking ...

3. nature.com nature.com/articles/s41562-025-02295-2

Efficacy of digital interventions for smoking cessation by ... SMS interventions demonstrated the highest efficacy (RR 1.63, 95% CI 1.38–1.92), indicating a 63% increased smoking cessation success compared ...

4. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-024-02570-9

Effectiveness of smoking cessation interventions among adults Results suggest that pharmacological and behavioural interventions may help the general smoking population quit smoking with observed small/mild harms ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551741123003686

Smoking cessation intervention in the community pharmacy At 12 months, 54.3% and 37.1% patients from the intervention and the control groups reported smoking cessation, respectively. The difference in probability of ...

6. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=24102596

Clinical Effort Against Secondhand Smoke Exposure (CEASE) CEASE is an intervention that trains pediatric care practices to modify their systems so they can routinely address family smoking behavior and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3874254/

The Clinical Effort Against Secondhand Smoke Exposure ... The CEASE program trains pediatricians and office staff to systematically provide cessation counseling and interventions to parents and other adults who smoke.

8. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2822687

Public Health Impact of FDA's Request for Additional Safety ... We applied a 10% probability of smoking relapse after 1 year of abstinence. For life expectancy gains from smoking cessation at different ages ( ...

9. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7329a1.htm

Adult Smoking Cessation — United States, 2022 | MMWR In 2022, most adults who smoked wanted to quit, and approximately one half tried to quit in the past year, but fewer than 10% quit successfully.

10. aafp.org aafp.org/pubs/afp/issues/2022/1100/smoking-cessation-interventions.html

Smoking Cessation Interventions Brief discussions with clinicians can increase cessation rates by two-thirds, and more intensive treatment doubles the chances of quitting.