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OpenTrials
Completed

NCT Number: NCT03087617

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Partners

Minneapolis, Minnesota, 55405, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Smoking Cessation Report, Report

Smoking Cessation Counseling

Behavioral

45 minute counseling session with a tobacco treatment specialist.

Usual Care

Other

Usual Care for Lung Cancer Screening patients.

Primary outcomes

  1. Report's Impact on Calling a Quitline Number

    Time frame: 3 weeks after intervention.

    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.

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

    Time frame: 3 weeks 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:

    • Not at all ready
    • Slightly ready
    • Moderately ready
    • Very ready

  3. Report's Impact on Calling a Quitline Number

    Time frame: 3 months after intervention

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

  4. Report's Impact on Calling a Quitline Number

    Time frame: 6 months after intervention

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

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

    Time frame: 3 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:

    • Not at all ready
    • Slightly ready
    • Moderately ready
    • Very ready

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

    Time frame: 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:

    • Not at all ready
    • Slightly ready
    • Moderately ready
    • Very ready

Sponsors and collaborators

Lead sponsor

Imbio

Industry

Collaborators

  • HealthPartners Institute
  • Mayo Clinic
  • National Cancer Institute (NCI)
  • University of Michigan
  • University of Minnesota

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2017
Registry last updated
Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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