Personalized Smoking Cessation Tool Based on Patient Lung CT Image

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Usual Care; Device: Imbio Smoking Cessation Report; Behavioral: Smoking Cessation Counseling

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 Type: Interventional
• Enrollment (Actual): 321
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55405
      • Health Partners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Usual Care; Usual Care for Lung Cancer Screening patients.
Experimental: Usual Care + 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.	Other: Usual Care; Usual Care for Lung Cancer Screening patients.; Device: Imbio Smoking Cessation Report; 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.; Other Names: Smoking Cessation Report; Report
Active Comparator: Usual Care + 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.	Other: Usual Care; Usual Care for Lung Cancer Screening patients.; Behavioral: Smoking Cessation Counseling; 45 minute counseling session with a tobacco treatment specialist.
Experimental: Usual Care + Imbio Smoking Cessation Report + Counseling; In addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report.	Other: Usual Care; Usual Care for Lung Cancer Screening patients.; Device: Imbio Smoking Cessation Report; 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.; Other Names: Smoking Cessation Report; Report; Behavioral: Smoking Cessation Counseling; 45 minute counseling session with a tobacco treatment specialist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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: Not at all ready; Slightly ready; Moderately ready; Very ready	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.	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.	6 months 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: Not at all ready; Slightly ready; Moderately ready; Very ready	3 months 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: Not at all ready; Slightly ready; Moderately ready; Very ready	6 months after intervention

Collaborators and Investigators

• Sponsor: Imbio
• Collaborators: National Cancer Institute (NCI); Mayo Clinic; University of Michigan; University of Minnesota; HealthPartners Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2018
• Primary Completion (Actual): February 21, 2021
• Study Completion (Actual): August 23, 2021

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 16, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: R44CA203050 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No