Personalized Smoking Cessation Tool Based on Patient Lung CT Image

NCT03087617 | Completed Results FDA Device

• 1 other identifier: R44CA203050
• Study Type: interventional
• Target: 321
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (6)

• 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: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. 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: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. 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: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready

  6 months after intervention

Study Arms (4)

Usual Care

ACTIVE COMPARATOR

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 + Imbio Smoking Cessation Report

EXPERIMENTAL

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.

Device: Imbio Smoking Cessation Report; Other: Usual Care

Usual Care + Counseling

ACTIVE COMPARATOR

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.

Behavioral: Smoking Cessation Counseling; Other: Usual Care

Usual Care + Imbio Smoking Cessation Report + Counseling

EXPERIMENTAL

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

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

Interventions

Imbio Smoking Cessation Report DEVICE

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.

Also known as: Smoking Cessation Report, Report

Usual Care + Imbio Smoking Cessation Report; Usual Care + Imbio Smoking Cessation Report + Counseling

Smoking Cessation Counseling BEHAVIORAL

45 minute counseling session with a tobacco treatment specialist.

Usual Care + Counseling; Usual Care + Imbio Smoking Cessation Report + Counseling

Usual Care OTHER

Usual Care for Lung Cancer Screening patients.

Usual Care; Usual Care + Counseling; Usual Care + Imbio Smoking Cessation Report; Usual Care + Imbio Smoking Cessation Report + Counseling

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imbio: lead
• National Cancer Institute (NCI): collaborator
• University of Michigan: collaborator
• Mayo Clinic: collaborator
• HealthPartners Institute: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Health Partners

Minneapolis, Minnesota, 55405, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Results Point of Contact

• Title: Director of Engineering
• Organization: Imbio, Inc

laurenkeith@imbio.com

612520360

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: University of Minnesota Office of Measurements Services will administer follow up calls to assess outcomes. Callers will be blinded to the arm to which the patients were assigned.
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2017
• First Posted: March 22, 2017
• Study Start: October 3, 2018
• Primary Completion: February 21, 2021
• Study Completion: August 23, 2021
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)