Digitally Enhanced Smoking Cessation for High Risk Smokers

NCT04691297 | Active Not Recruiting

• 1 other identifier: 20-457
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 2

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. .

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 7-day point prevalence smoking cessation rate

  biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,

  3 months

• 7-day point prevalence smoking cessation rate

  biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,

  6 months

• number of cigarettes smoked/day

  self-report number of cigarettes will be compared with exact Poisson test.

  3 months

• number of cigarettes smoked/day

  self-report number of cigarettes will be compared with exact Poisson test.

  6 months

• Lung cancer screening behavior measure

  (stage of low-dose computed tomography \[LDCT\] screening adoption) Lung Cancer Screening Behaviors\[20\] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,

  3 Months

• Lung cancer screening behavior measure

  (stage of low-dose computed tomography \[LDCT\] screening adoption) Lung Cancer Screening Behaviors\[20\] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,

  6 months

Secondary Outcomes (8)

• Completion rate

  1 month

• Completion rate

  3 months

• Percentage of the group perceive the film as just right in length

  1 month

• Percentage of the group indicate that the film would have value to others

  3 months

• Narrative Engagement Scale scores

  1 month

Study Arms (2)

Escape

EXPERIMENTAL

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

Other: Escape

Standard Care

EXPERIMENTAL

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

Other: Standard Care

Interventions

Escape 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.

Escape

Standard Care 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.

Standard Care

Eligibility Criteria

• Age: 55 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• American Association for Cancer Research: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Smoking; Smoking Cessation; Tobacco Smoking

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mary E. Cooley, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 31, 2020
• Study Start: February 1, 2021
• Primary Completion: February 1, 2023
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)