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Personalized Smoking Cessation Tool Based on Patient Lung CT Image

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ClinicalTrials.gov Identifier: NCT03087617
Recruitment Status : Recruiting
First Posted : March 22, 2017
Last Update Posted : February 27, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
University of Michigan
Mayo Clinic
HealthPartners Institute
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Imbio

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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Device: Imbio Smoking Cessation Report Behavioral: Smoking Cessation Counseling Other: Usual Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Other
Official Title: Personalized Smoking Cessation Tool Based on Patient Lung CT Image
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Other: Usual Care
Usual Care for Lung Cancer Screening patients.

Experimental: 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.
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.
Other Names:
  • Smoking Cessation Report
  • Report

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

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

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

Experimental: 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.
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.
Other Names:
  • Smoking Cessation Report
  • Report

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

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




Primary Outcome Measures :
  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.

  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.

  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.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03087617


Contacts
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Contact: Lauren A Keith, PhD 6082137100 laurenkeith@imbio.com

Locations
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United States, Minnesota
Health Partners Recruiting
Minneapolis, Minnesota, United States, 55405
Contact: Linda Loes    952-967-7862    Linda.M.Loes@HealthPartners.Com   
Principal Investigator: Charlene McEvoy, MD         
Sponsors and Collaborators
Imbio
National Cancer Institute (NCI)
University of Michigan
Mayo Clinic
HealthPartners Institute
University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: Imbio
ClinicalTrials.gov Identifier: NCT03087617     History of Changes
Other Study ID Numbers: R44CA203050 ( U.S. NIH Grant/Contract )
R44CA203050 ( U.S. NIH Grant/Contract )
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No