Personalized Smoking Cessation Tool Based on Patient Lung CT Image

Not Applicable

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT03087617
• Lead Sponsor: Imbio

Brief Summary

Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's effectiveness at motivating smokers to call a Quitline.

Detailed Description

Imbio is developing a Smoking Cessation Report (Report) that includes data analysis from a CT lung cancer screening exam. This randomized controlled (RCT) trial will clinically validate the Report's impact on: (a) Lung screening participants' motivation to make a quit attempt by calling a Quitline, and (b) the effectiveness of a 45-minute telephone smoking cessation counseling session for motivating an actual quit attempt and abstinence. The RCT will enroll approximately 400 randomly selected participants from lung screening programs at HealthPartners and University of Michigan. Participants will be randomly assigned to one of four conditions: 1) Usual Care + quitline phone number (created specifically for the trial and maintained for the length of the trial); 2) Usual Care + Report (Report will list Quitline number) 3) Usual Care + Counseling, or 4) Usual Care + Report + Counseling. Follow up assessment calls will be conducted with participants at three weeks, three months, and six months following the mailing of the report.

Study Timeline

• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-16
• Study First Posted: 2017-03-22
• Study Start: 2018-10-03
• Primary Completion: 2021-02-21
• Study Completion: 2021-08-23
• Results First Submitted: 2022-08-05
• Status Verified: 2022-09
• Results First Submitted QC: 2022-09-26
• Last Update Submitted: 2022-09-26
• Results First Posted: 2022-10-05
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 321

Inclusion Criteria

• 30-pack year smoking history
• currently smoke OR quit within the last 15 years and a category 1 or 2 Lung-RADS scan

Exclusion Criteria

• current use of smoking cessation medications
• scan read as a category 3, 4A, 4B or 4X in Lung-RADS
• unstable medical or psychiatric conditions
• current alcohol or drug use disorder
• past-month suicidal ideation
• past-year suicide attempt

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Report's Impact on Calling a Quitline Number	6 months after intervention	This outcome will be measured by whether the participant calls the Quitline number provided to them.
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call	6 months after intervention	This outcome will be measured by the participants' motivation to make a quit attempt and abstain from smoking. The question asked was: How ready are you to quit smoking?; Answer options include: 1. Not at all ready; 2. Slightly ready; 3. Moderately ready; 4. Very ready

Trial Locations

Locations (1)

Health Partners; 🇺🇸 Minneapolis, Minnesota, United States