Personalized Smoking Cessation Tool Based on Patient Lung CT Image

Smoking Cessation Clinical Trial

Official title:

Personalized Smoking Cessation Tool Based on Patient Lung CT Image

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087617
• Other study ID #: R44CA203050
• Secondary ID: R44CA203050
• Status: Completed
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: August 23, 2021

Study information

• Verified date: September 2022
• Source: Imbio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: August 23, 2021
• Est. primary completion date: February 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Behavioral:
• Smoking Cessation Counseling
45 minute counseling session with a tobacco treatment specialist.

Other:
• Usual Care
Usual Care for Lung Cancer Screening patients.

Locations

Country	Name	City	State
United States	Health Partners	Minneapolis	Minnesota

Sponsors (6)

Lead Sponsor	Collaborator
Imbio	HealthPartners Institute, Mayo Clinic, National Cancer Institute (NCI), University of Michigan, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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