Trials / Active Not Recruiting
Active Not RecruitingNCT04691297
Digitally Enhanced Smoking Cessation for High Risk Smokers
A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 153 (actual)
- Sponsor
- Dana-Farber Cancer Institute · Academic / Other
- Sex
- All
- Age
- 55 Years – 77 Years
- Healthy volunteers
- Accepted
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. .
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 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. |
| 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. |
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2023-02-01
- Completion
- 2026-12-01
- First posted
- 2020-12-31
- Last updated
- 2025-12-19
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04691297. Inclusion in this directory is not an endorsement.