Digitally Enhanced Smoking Cessation for High Risk Smokers

NCT ID: NCT04691297

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2026-12-01

Brief Summary

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.

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Detailed Description

• This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.
• This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:

• ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening
• Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks
• Participants will be in this research study for up to 6-months.
• It is expected that about 250 people will take part in this research study.

Conditions

Smoking; Smoking Cessation; Lung Cancer Screening; Smoking, Tobacco; Smoking Behaviors

Keywords

Smoking; Smoking Cessation; Lung Cancer Screening; Smoking, Tobacco; Smoking Behaviors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Escape

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

Group Type: EXPERIMENTAL

Escape

Intervention Type: OTHER

The ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider.

Standard Care

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 Type: EXPERIMENTAL

Standard Care

Intervention Type: OTHER

Participants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening.

Interventions

Escape

The ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider.

Intervention Type: OTHER

Standard Care

Participants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 55 to 77 years of age
• No previous history of lung cancer
• ECOG performance status < 2
• ≥ 30 pack year smoking history
• Smoke ≥ 5 cigarettes/day
• Own a mobile phone with access to a video call application
• Has a primary care provider (PCP)
• Provide contact information for the PCP
• Active health insurance
• Has not had LDCT screening
• English speaking
• Can complete an interview

Exclusion Criteria

• Hospitalization for severe mental illness within the last year.
• The following special populations will not be included

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 77 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Association for Cancer Research

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Mary E. Cooley, Phd

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mary E. Cooley, PhD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

20-457

Identifier Type: -

Identifier Source: org_study_id