Smoking CessationNCT03087617
Personalized Smoking Cessation Tool Based on Patient Lung CT Image
A study testing Imbio Smoking Cessation Report and Smoking Cessation Counseling in people with Smoking Cessation, run by Imbio at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Imbio Smoking Cessation Report and Smoking Cessation Counseling
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 321 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2018to 23 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 30-pack year smoking history
- currently smoke OR quit within the last 15 years and a category 1 or 2 Lung-RADS scan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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 effectiveness at motivating smokers to call a Quitline.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Imbio Smoking Cessation Report, Smoking Cessation Counseling, Usual Care
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imbio Smoking Cessation ReportDevice
Also called Smoking Cessation Report, 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 CounselingBehavioural
45 minute counseling session with a tobacco treatment specialist.
Usual CareOther
Usual Care for Lung Cancer Screening patients.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
| Usual Care + Imbio Smoking Cessation Report | Experimental | 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. Receives: Device: Imbio Smoking Cessation Report; Other: Usual Care |
| Usual Care + Counseling | Active comparator | 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. Receives: Behavioral: Smoking Cessation Counseling; Other: Usual Care |
| Usual Care + Imbio Smoking Cessation Report + Counseling | Experimental | In addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report. Receives: Device: Imbio Smoking Cessation Report; Behavioral: Smoking Cessation Counseling; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks after intervention.
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
Measured: 3 weeks after intervention
Report's Impact on Calling a Quitline Number
This outcome will be measured by whether the participant calls the Quitline number provided to them.
Measured: 3 months after intervention
Report's Impact on Calling a Quitline Number
This outcome will be measured by whether the participant calls the Quitline number provided to them.
Measured: 6 months after intervention
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
Measured: 3 months after intervention
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
Measured: 6 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start3 Oct 2018
- Primary completion21 Feb 2021
- Study completion23 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imbio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), University of Michigan, Mayo Clinic, HealthPartners Institute, University of Minnesota
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087617
- Sponsor's protocol ID
- R44CA203050
- Other IDs
- R44CA203050
- Status last verified
- Sep 2022
- First submitted
- 2 Mar 2017
- Last updated
- 5 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Smoking Cessation Tool Based on Patient Lung CT Image
- ClinicalTrials.gov ID
- NCT03087617
- Acronym / sponsor ID
- R44CA203050
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 321 participants (actual)
- Lead sponsor
- ImbioIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), University of Michigan, Mayo Clinic, HealthPartners Institute, University of Minnesota
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 21 Feb 2021 (actual)
- Study completion
- 23 Aug 2021 (actual)
- First posted
- 22 Mar 2017 (actual)
- Results
- Posted 5 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual CareUsual 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 + Imbio Smoking Cessation Report | Experimental | Device: Imbio Smoking Cessation Report, Other: Usual CareIn 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. |
| Usual Care + Counseling | Active comparator | Behavioral: Smoking Cessation Counseling, Other: Usual CareIn 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. |
| Usual Care + Imbio Smoking Cessation Report + Counseling | Experimental | Device: Imbio Smoking Cessation Report, Behavioral: Smoking Cessation Counseling, Other: Usual CareIn addition to the Usual Care and Counseling described above, patients in this arm will also receive the Report. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 30-pack year smoking history
- currently smoke OR quit within the last 15 years and a category 1 or 2 Lung-RADS scan
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imbio Smoking Cessation ReportAlso: Smoking Cessation Report, ReportResearch 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. | Device | Usual Care + Imbio Smoking Cessation Report, Usual Care + Imbio Smoking Cessation Report + Counseling |
| Smoking Cessation Counseling45 minute counseling session with a tobacco treatment specialist. | Behavioural | Usual Care + Counseling, Usual Care + Imbio Smoking Cessation Report + Counseling |
| Usual CareUsual Care for Lung Cancer Screening patients. | Other | Usual Care, Usual Care + Counseling, Usual Care + Imbio Smoking Cessation Report, Usual Care + Imbio Smoking Cessation Report + Counseling |
Primary outcome
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.
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: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready
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.
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.
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: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready
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: 1. Not at all ready 2. Slightly ready 3. Moderately ready 4. Very ready
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imbio Smoking Cessation Report and Smoking Cessation Counseling in people with Smoking Cessation, run by Imbio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Report's Impact on Calling a Quitline Number (time frame: 3 weeks after intervention.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.