Personalized Smoking Cessation Tool Based on Patient Lung CT Image

Not Applicable

Completed

Conditions: Smoking Cessation

Interventions: Device: Imbio Smoking Cessation Report
Other: Usual Care
Behavioral: Smoking Cessation Counseling

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.

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

Arm && Interventions

Group	Intervention	Description
Usual Care + Imbio Smoking Cessation Report	Usual Care	In this arm, patients will receive the Usual Care described above and will additionally be provided with the Report. In this arm, the Report will provide the Quitline number.
Usual Care	Usual Care	Usual Care includes a lung cancer screening CT exam. Following the screen, a radiologist will analyze the CT scan image and send the results to the patient's Primary Care Physician (PCP). If the scan is read as a category 1 or 2 in the Lung Reporting and Data System (Lung-RADS), patients are provided a letter in the mail with their results. If the scan is read as a category 3, 4A, 4B, or 4X in Lung-RADS the patient will be contacted by their primary care physician's office and told to schedule a follow up appointment. Either in the letter or at the follow up appointment, patients will be given a Quitline number created specifically for this trial and maintained for the duration.
Usual Care + Imbio Smoking Cessation Report + Counseling	Smoking Cessation Counseling	In addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report.
Usual Care + Imbio Smoking Cessation Report	Imbio Smoking Cessation Report	In this arm, patients will receive the Usual Care described above and will additionally be provided with the Report. In this arm, the Report will provide the Quitline number.
Usual Care + Counseling	Smoking Cessation Counseling	In addition to the Usual Care described above, patients in this arm will participate in a 45 minute smoking cessation counseling session. Approximately three Tobacco Treatment Specialists will be trained to ensure consistent counseling methodology. Counselors will utilize a patient centered approach grounded in Motivational Interviewing skills to elicit perceived benefits for stopping smoking and to enhance self-efficacy for stopping. A major emphasis of a call is to enroll the caller in formal cessation programs and/or convince them to use FDA approved medication as part of a quit attempt. Study participants who desire further smoking cessation support after their session will be connected with the appropriate organization.
Usual Care + Counseling	Usual Care	In addition to the Usual Care described above, patients in this arm will participate in a 45 minute smoking cessation counseling session. Approximately three Tobacco Treatment Specialists will be trained to ensure consistent counseling methodology. Counselors will utilize a patient centered approach grounded in Motivational Interviewing skills to elicit perceived benefits for stopping smoking and to enhance self-efficacy for stopping. A major emphasis of a call is to enroll the caller in formal cessation programs and/or convince them to use FDA approved medication as part of a quit attempt. Study participants who desire further smoking cessation support after their session will be connected with the appropriate organization.
Usual Care + Imbio Smoking Cessation Report + Counseling	Imbio Smoking Cessation Report	In addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report.
Usual Care + Imbio Smoking Cessation Report + Counseling	Usual Care	In addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report.

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