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

Trial Summary

What is the purpose of this trial?

This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care. The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening. .

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 data supports the effectiveness of the treatment ESCAPE for smoking cessation?

Research shows that starting smoking cessation treatment in the hospital and continuing with support like telephone counseling or quitlines can help people quit smoking successfully after they leave the hospital. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The safety of the treatment, known under various names like Varenicline, Chantix, and others, has been evaluated in different contexts. While specific safety data for this treatment isn't detailed in the provided research, it is important to note that adverse events (unwanted effects) are a common consideration in drug safety evaluations, and regulatory agencies use adverse event reporting systems to monitor and guide safety assessments. ^{6 7 8 9 10}

How does the ESCAPE treatment for smoking differ from other treatments?

The ESCAPE treatment for smoking is unique because it may incorporate a combination of pharmacological aids and social support resources, as seen in similar interventions, which can enhance the effectiveness of smoking cessation efforts. This approach is different from standard treatments that often focus solely on medication or behavioral support. ^{11 12 13 14 15}

Research Team

Mary E Cooley, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

Own a mobile phone with access to a video call application

I am between 55 and 77 years old.

≥ 30 pack year smoking history

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Effectiveness of an inpatient smoking cessation program. [2019]

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

Helping Hospitalized Smokers: A Factorial RCT of Nicotine Patches and Counseling. [2018]

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

Interactive Voice Response Calls to Promote Smoking Cessation after Hospital Discharge: Pooled Analysis of Two Randomized Clinical Trials. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial. [2018]

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

Increasing nursing referral to telephone quitlines for smoking cessation using a web-based program. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Withdrawn 2.0-update on withdrawn drugs with pharmacovigilance data. [2023]

8. New Zealand 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. [2023]

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

Strategies for safety reporting in substance abuse trials. [2013]

10. England 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. [2022]

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

Resumption of smoking after release from a tobacco-free correctional facility. [2022]

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

Role of pharmacological aids and social supports in smoking cessation associated with Quebec's 2000 Quit and Win campaign. [2006]

13. England pubmed.ncbi.nlm.nih.gov

Staying Quit After Release (SQuARe) trial protocol: a randomised controlled trial of a multicomponent intervention to maintain smoking abstinence after release from smoke-free prisons in Victoria, Australia. [2020]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Interest in Smoking Cessation Related to a Smoke-Free Policy Among Homeless Adults. [2022]

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

Preventing relapse in the treatment of nicotine addiction: current issues and future directions. [2017]