Clinical trial NCT03087617: Personalized Smoking Cessation Tool Based on Patient Lung CT Image
Official title: Personalized Smoking Cessation Tool Based on Patient Lung CT Image
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Imbio
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: University of Michigan
name: Mayo Clinic
name: HealthPartners Institute
name: University of Minnesota
First posted: 2017-03-22
Enrollment: 321
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Report's Impact on Calling a Quitline Number
timeFrame: 3 weeks after intervention.
measure: Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
timeFrame: 3 weeks after intervention
measure: Report's Impact on Calling a Quitline Number
timeFrame: 3 months after intervention
measure: Report's Impact on Calling a Quitline Number
timeFrame: 6 months after intervention
measure: Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
timeFrame: 3 months after intervention
measure: Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
timeFrame: 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Health Partners
state: Minnesota
Study officials:
References: