Trial Outcomes & Findings for Personalized Smoking Cessation Tool Based on Patient Lung CT Image (NCT NCT03087617)
NCT ID: NCT03087617
Last Updated: 2022-10-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
321 participants
Primary outcome timeframe
3 weeks after intervention.
Results posted on
2022-10-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
79
|
80
|
82
|
80
|
|
Overall Study
COMPLETED
|
47
|
50
|
52
|
41
|
|
Overall Study
NOT COMPLETED
|
32
|
30
|
30
|
39
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
32
|
30
|
30
|
39
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Usual Care
n=79 Participants
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
n=80 Participants
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
n=82 Participants
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
n=80 Participants
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.
|
Total
n=321 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 6 • n=79 Participants
|
65 years
STANDARD_DEVIATION 6 • n=80 Participants
|
65 years
STANDARD_DEVIATION 5.45 • n=82 Participants
|
65 years
STANDARD_DEVIATION 6 • n=80 Participants
|
65 years
STANDARD_DEVIATION 6 • n=321 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=79 Participants
|
38 Participants
n=80 Participants
|
52 Participants
n=82 Participants
|
38 Participants
n=80 Participants
|
166 Participants
n=321 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=79 Participants
|
42 Participants
n=80 Participants
|
30 Participants
n=82 Participants
|
42 Participants
n=80 Participants
|
155 Participants
n=321 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
79 participants
n=79 Participants
|
80 participants
n=80 Participants
|
82 participants
n=82 Participants
|
80 participants
n=80 Participants
|
321 participants
n=321 Participants
|
PRIMARY outcome
Timeframe: 3 weeks after intervention.Population: 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.
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 weeks after interventionThis 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
Outcome measures
| Measure |
Usual Care
n=66 Participants
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
n=72 Participants
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
n=75 Participants
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
n=69 Participants
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.
|
|---|---|---|---|---|
|
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
|
2.73 score on a scale
Standard Deviation 0.84
|
3.15 score on a scale
Standard Deviation 0.90
|
2.92 score on a scale
Standard Deviation 0.87
|
2.97 score on a scale
Standard Deviation 0.92
|
PRIMARY outcome
Timeframe: 3 months after interventionPopulation: \*\*\*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.
This outcome will be measured by whether the participant calls the Quitline number provided to them.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 6 months after interventionPopulation: \*\*\*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.
This outcome will be measured by whether the participant calls the Quitline number provided to them.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 months after interventionThis 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
Outcome measures
| Measure |
Usual Care
n=53 Participants
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
n=53 Participants
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
n=54 Participants
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
n=46 Participants
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.
|
|---|---|---|---|---|
|
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
|
2.75 score on a scale
Standard Deviation 0.92
|
3.08 score on a scale
Standard Deviation 0.92
|
2.61 score on a scale
Standard Deviation 0.98
|
3.07 score on a scale
Standard Deviation 0.90
|
PRIMARY outcome
Timeframe: 6 months after interventionThis 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
Outcome measures
| Measure |
Usual Care
n=47 Participants
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
n=50 Participants
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
n=52 Participants
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
n=41 Participants
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.
|
|---|---|---|---|---|
|
Report's Impact Making a Quit Attempt Measured Via Follow-up Phone Call
|
2.85 score on a scale
Standard Deviation 0.88
|
3.00 score on a scale
Standard Deviation 0.93
|
2.80 score on a scale
Standard Deviation 0.93
|
3.07 score on a scale
Standard Deviation 0.96
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care + Imbio Smoking Cessation Report
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care + Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care + Imbio Smoking Cessation Report + Counseling
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place