Personalized Smoking Cessation Tool Based on Patient Lung CT Image
NCT ID: NCT03087617
Last Updated: 2022-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
321 participants
INTERVENTIONAL
2018-10-03
2021-08-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
SINGLE
Study Groups
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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.
Usual Care
Usual Care for Lung Cancer Screening patients.
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.
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.
Usual Care
Usual Care for Lung Cancer Screening patients.
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.
Smoking Cessation Counseling
45 minute counseling session with a tobacco treatment specialist.
Usual Care
Usual Care for Lung Cancer Screening patients.
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.
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.
Smoking Cessation Counseling
45 minute counseling session with a tobacco treatment specialist.
Usual Care
Usual Care for Lung Cancer Screening patients.
Interventions
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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.
Smoking Cessation Counseling
45 minute counseling session with a tobacco treatment specialist.
Usual Care
Usual Care for Lung Cancer Screening patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* currently smoke OR quit within the last 15 years and a category 1 or 2 Lung-RADS scan
Exclusion Criteria
* 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
55 Years
80 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Michigan
OTHER
Mayo Clinic
OTHER
HealthPartners Institute
OTHER
University of Minnesota
OTHER
Imbio
INDUSTRY
Responsible Party
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Locations
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Health Partners
Minneapolis, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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