Escape for Smoking

Recruiting at 1 trial location

Overseen By Mary E. Cooley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Severe mental illness, Pregnant, others

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

Compensation: Varies

Number of Visits: 8

Duration: 6 months

153 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding lung screening to a smoking cessation program can improve lung health. It compares the ESCAPE program, which includes phone counseling, free nicotine therapy, and lung screening education, to usual care that offers a single counseling session and similar resources. The trial seeks participants who smoke at least five cigarettes a day, have never had lung cancer, and have a long history of smoking (30 pack-years or more). Participants must have access to a mobile phone for video calls and must not have undergone lung screening before.

As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance smoking cessation programs and improve lung health.

Will I have to stop taking my current medications?

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 ESCAPE program is safe for improving lung health?

Research has shown that the ESCAPE program helps people quit smoking through various support methods. Participants in similar trials have found this program effective in aiding smoking cessation. Importantly, these studies have not reported any serious side effects from the program.

The ESCAPE program includes counseling sessions and offers nicotine replacement therapy, which most people tolerate well. Nicotine replacement therapy eases withdrawal symptoms when quitting smoking.

Adding lung screening to the program aims to enhance its benefits by encouraging long-term smoking cessation. So far, no major safety concerns have arisen with this approach. Overall, the treatment appears safe, focusing on supporting individuals in successfully quitting smoking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ESCAPE program because it offers a comprehensive approach to quitting smoking that goes beyond the standard single counseling session. Unlike typical smoking cessation options that may only include brief support, ESCAPE provides eight phone counseling sessions, giving participants ongoing, personalized guidance. Additionally, like standard care, it offers nicotine replacement therapy at no cost, but it also emphasizes education about lung screening, which could help in early detection and prevention of lung cancer. This multifaceted strategy could lead to higher success rates in quitting smoking, making it a promising alternative for those struggling to quit.

What evidence suggests that the ESCAPE program is effective for smoking cessation?

Research has shown that the ESCAPE program, one of the treatment options in this trial, helps women with HIV quit smoking and remain smoke-free for up to three months. In past studies, participants in similar programs that use multiple methods to quit smoking achieved better success rates than those who received standard care. This trial will compare the ESCAPE program, which includes counseling, nicotine replacement therapy, and education about lung health, with the Standard Care program, which also provides counseling and nicotine replacement therapy. The researchers aim to determine if the additional education in the ESCAPE program can further improve quit rates and lung health. Overall, combining counseling, medication, and education appears to be a promising approach to help people quit smoking. ^{1 2 6 7 8}

Who Is on the Research Team?

Mary E Cooley, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for high-risk smokers aged 55-77 who smoke at least 5 cigarettes a day and have a history of heavy smoking (≥30 pack years). Participants must be English-speaking, own a mobile phone with video call capability, have active health insurance, and can complete an interview. They should not have had lung cancer or low-dose CT screening before.

Inclusion Criteria

I am between 55 and 77 years old.

≥ 30 pack year smoking history

Own a mobile phone with access to a video call application

Exclusion Criteria

I am unable to give consent for medical procedures.

Hospitalization for severe mental illness within the last year

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the ESCAPE program with 8 counseling sessions and nicotine replacement therapy or usual care with 1 counseling session and nicotine replacement therapy

6 months

8 visits (phone) for ESCAPE, 1 visit (phone) for usual care

Follow-up

Participants are monitored for smoking cessation and lung health improvements

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ESCAPE
• Standard Care

Trial Overview The study compares the ESCAPE program—a smoking cessation approach that includes education on lung screening—to standard care. The goal is to see if adding lung screening information helps people quit smoking more effectively and improves their overall lung health.

How Is the Trial Designed?

Group I: Standard Care Experimental Treatment 1 Intervention

The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks and an educational brochure about lung cancer screening

Group II: Escape Experimental Treatment 1 Intervention

The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Association for Cancer Research

Collaborator

Trials

9

Recruited

830+

Published Research Related to This Trial

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

The study developed a method to extract comprehensive drug safety information from adverse event narratives using natural language processing (NLP), analyzing 3723 narratives from the Korea Adverse Event Reporting System (KAERS) between 2015 and 2019.

The KAERS-BERT model achieved high performance in extracting relevant data, improving data completeness by an average of 3.24% in structured fields, indicating that enhanced NLP techniques can significantly improve the quality of drug safety information in spontaneous reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automatic Extraction of Comprehensive Drug Safety Information from Adverse Drug Event Narratives in the Korea Adverse Event Reporting System Using Natural Language Processing Techniques. Kim, S., Kang, T., Chung, TK., et al.[2023]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

A study involving 600 hospitalized smokers tested a brief intervention to facilitate access to telephone quitline services, but found no difference in 6-month abstinence rates compared to standard cessation advice, with both groups reporting a 24% abstinence rate.

Despite 65% of the intervention group completing the quitline intake call, the facilitation intervention did not enhance the effectiveness of quitlines for helping hospitalized smokers quit, suggesting that quitlines may not be a viable solution for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial. Warner, DO., Nolan, MB., Kadimpati, S., et al.[2018]

A Web-based educational program significantly improved nurses' ability to refer smokers to a quitline and perform smoking cessation interventions, with 333 nurses participating in the study across 30 hospitals.

Nurses who accessed the educational program showed a 74% higher likelihood of consistently referring smokers to the quitline compared to those who only received printed materials, highlighting the effectiveness of interactive training methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing nursing referral to telephone quitlines for smoking cessation using a web-based program. Sarna, L., Bialous, SA., Ong, MK., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06746025

Study Details | NCT06746025 | Examining the Efficacy of a ... The primary purpose of this trial is to assess the efficacy of the holistic approach to quitting, and to gauge the program results against any ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4309513/

Randomized controlled trial to assess the short-term ... Smoking outcomes. There were no significant between-group differences in 2-week point prevalence abstinence at the 8-week primary end-point [control 40.3% ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6387550/

Effectiveness of a new multi-component smoking cessation ... Strong evidences showed that smoking-cessation intervention are cost-effective even with resource-intensive intervention because of quality- ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.16718

intEgrating Smoking Cessation treatment As part of usual ... Follow-up was at 3 and 6 months. The primary outcome was 'study completion' by 3 months. Other outcomes included acceptability, satisfaction, ...

5. isrctn.com isrctn.com/ISRCTN99531779

The ESCAPE study: offering smoking cessation treatment ... Also, the results from this study will help to inform a large study examining the effectiveness of offering smoking cessation treatment in psychological therapy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11986290/

intEgrating Smoking Cessation treatment As part of usual ... ESCAPE (intEgrating smoking cessation treatment as part of usual psychological care for dEpression and anxiety) is a pragmatic, two‐armed, randomised and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003317

Protocol for a randomized controlled trial of the Enhanced ... This study will test a smoking cessation intervention using personal stories and a lung cancer screening decision-aide compared to standard care.

8. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-019-0197-2

Effectiveness of a new multi-component smoking cessation ... Overall, smokers who received the intervention were almost three times more likely to stop smoking (aOR 2.92 95% confidence interval 1.56–5.50) ...