Digitally Enhanced Smoking Cessation for High Risk Smokers

Dana-Farber Cancer Institute

Status: Active, not recruiting

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

Treatments: Other: Standard Care; Other: Escape

Study type: Interventional

Funder types: Other

Identifiers

NCT04691297

20-457

Details and patient eligibility

About

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.

.

Full 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.

Enrollment: 153 patients

Sex: All

Ages: 55 to 77 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

153 participants in 2 patient groups

Escape

Experimental group

Description:

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

Treatment:

Other: Escape

Standard Care

Experimental group

Description:

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

Treatment:

Other: Standard Care