Personalized Smoking Cessation Tool Based on Patient Lung CT Image

Imbio

Status: Completed

Conditions: Smoking Cessation

Treatments: Device: Imbio Smoking Cessation Report; Behavioral: Smoking Cessation Counseling; Other: Usual Care

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03087617

R44CA203050 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 321 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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321 participants in 4 patient groups

Usual Care

Active Comparator group

Description:

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.

Treatment:

Other: Usual Care

Usual Care + Imbio Smoking Cessation Report

Experimental group

Description:

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.

Treatment:

Device: Imbio Smoking Cessation Report

Other: Usual Care

Usual Care + Counseling

Active Comparator group

Description:

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.

Treatment:

Behavioral: Smoking Cessation Counseling

Other: Usual Care

Usual Care + Imbio Smoking Cessation Report + Counseling

Experimental group

Description:

In addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report.

Treatment:

Device: Imbio Smoking Cessation Report

Behavioral: Smoking Cessation Counseling

Other: Usual Care