Personalized Smoking Cessation Tool Based on Patient Lung CT Image

Imbio321 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

321

Conditions

Smoking Cessation

Interventions

Imbio Smoking Cessation ReportDEVICE

Research coordinators at the University of Michigan and HealthPartners will be provided access to the research version of LDA via an Imbio website. Following consent and lung screen, research coordinators will manually upload the study participants' images and download a resulting Report. Radiologists have been designated at both sites to review and approve the Report prior to mailing to participants. The Report will include information including the percent of damaged lung volume.

Smoking Cessation CounselingBEHAVIORAL

45 minute counseling session with a tobacco treatment specialist.

Usual CareOTHER

Usual Care for Lung Cancer Screening patients.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Health Partners

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Report's Impact on Calling a Quitline Number

This outcome will be measured by whether the participant calls the Quitline number provided to them. \*\*\*Given logistical complexities, it was never the intention to measure this outcome on a participant level, but rather to compare the arms as different groups to see if there is a difference in the number of calls received for each groups Quitline number, which was automatically monitored. Unfortunately, it because apparent that the monitored Quitline numbers were subject to many robocalls and that data because too unreliable to be analyzed.

Time frame: 3 weeks after intervention.

Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call

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

Time frame: 3 weeks after intervention

Report's Impact on Calling a Quitline Number

This outcome will be measured by whether the participant calls the Quitline number provided to them.

Time frame: 3 months after intervention

Report's Impact on Calling a Quitline Number

This outcome will be measured by whether the participant calls the Quitline number provided to them.

Time frame: 6 months after intervention

Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call

Time frame: 3 months after intervention

Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call

Data from ClinicalTrials.gov

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