Clinical trial NCT04691297: Digitally Enhanced Smoking Cessation for High Risk Smokers
Official title: A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Smoking
Smoking Cessation
Lung Cancer Screening
Smoking, Tobacco
Smoking Behaviors
Keywords: Smoking
Smoking Cessation
Lung Cancer Screening
Smoking, Tobacco
Smoking Behaviors
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Association for Cancer Research
First posted: 2020-12-31
Enrollment: 153
Sex: ALL
Minimum age (years): 55
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 7-day point prevalence smoking cessation rate
timeFrame: 3 months
measure: 7-day point prevalence smoking cessation rate
timeFrame: 6 months
measure: number of cigarettes smoked/day
timeFrame: 3 months
measure: number of cigarettes smoked/day
timeFrame: 6 months
measure: Lung cancer screening behavior measure
timeFrame: 3 Months
measure: Lung cancer screening behavior measure
timeFrame: 6 months
Secondary outcomes:
measure: Completion rate
timeFrame: 1 month
measure: Completion rate
timeFrame: 3 months
measure: Percentage of the group perceive the film as just right in length
timeFrame: 1 month
measure: Percentage of the group indicate that the film would have value to others
timeFrame: 3 months
measure: Narrative Engagement Scale scores
timeFrame: 1 month
measure: Narrative Engagement Scale scores
timeFrame: 3 months
measure: Polygenic risk score (PRS)
timeFrame: 6 months
measure: Qualitative interviews
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Mary E. Cooley, PhD
role: PRINCIPAL_INVESTIGATOR
References: