Trial Outcomes & Findings for Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment (NCT NCT03612804)
NCT ID: NCT03612804
Last Updated: 2024-10-08
Results Overview
The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
944 participants
Primary outcome timeframe
12 months after lung cancer screening visit
Results posted on
2024-10-08
Participant Flow
This was a cluster-randomized trial in which providers were randomized to one of two care arms. Patient participants were assigned to an arm based on their provider's care assignment.
142 providers and 3,503 patients were screened for eligibility. 26 providers were excluded (19 opt-out before enrolling any patients, 7 not primary care providers) and 2,675 patients were excluded (1,865 not meeting initial inclusion/exclusion criteria, 366 no show to LCS, 178 CT scan not LCS, 130 lung-RADS 4, 87 no copay coverage, 9 provider retired/withdrawn before LCS, 40 no local coordinator to enter notes/COVID complications). 116 providers and 828 patients were randomized.
Participant milestones
| Measure |
Unstructured Care: Providers
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
Patients seen by these providers who receive lung cancer screening will be assigned to the unstructured care arm.
|
Unstructured Care: Patients
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Providers
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
Patients seen by these providers who receive lung cancer screening will be assigned to the proactive care arm.
|
Proactive Care: Patients
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
47
|
422
|
69
|
406
|
|
Overall Study
COMPLETED
|
46
|
412
|
60
|
378
|
|
Overall Study
NOT COMPLETED
|
1
|
10
|
9
|
28
|
Reasons for withdrawal
| Measure |
Unstructured Care: Providers
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
Patients seen by these providers who receive lung cancer screening will be assigned to the unstructured care arm.
|
Unstructured Care: Patients
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Providers
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
Patients seen by these providers who receive lung cancer screening will be assigned to the proactive care arm.
|
Proactive Care: Patients
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|---|---|
|
Overall Study
Death
|
0
|
7
|
0
|
8
|
|
Overall Study
Medication copay coverage issues
|
0
|
0
|
0
|
17
|
|
Overall Study
Not current smoker at time of screening
|
0
|
1
|
0
|
3
|
|
Overall Study
Non-veteran status
|
0
|
1
|
0
|
0
|
|
Overall Study
Misassignment to a proactive arm provider
|
0
|
1
|
0
|
0
|
|
Overall Study
Provider retired from VA
|
0
|
0
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
7
|
0
|
|
Overall Study
Provider involved with study activities
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Data not collected for providers.
Baseline characteristics by cohort
| Measure |
Unstructured Care: Providers
n=47 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
Patients seen by these providers who receive lung cancer screening will be assigned to the unstructured care arm.
|
Unstructured Care: Patients
n=412 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Providers
n=69 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
Patients seen by these providers who receive lung cancer screening will be assigned to the proactive care arm.
|
Proactive Care: Patients
n=378 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
Total
n=906 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
—
|
66.7 years
STANDARD_DEVIATION 5.9 • n=412 Participants • Data not collected for providers.
|
—
|
66.6 years
STANDARD_DEVIATION 6.5 • n=378 Participants • Data not collected for providers.
|
66.7 years
STANDARD_DEVIATION 6.2 • n=790 Participants • Data not collected for providers.
|
|
Sex: Female, Male
Female
|
—
|
19 Participants
n=412 Participants • Data not collected for providers.
|
—
|
18 Participants
n=378 Participants • Data not collected for providers.
|
37 Participants
n=790 Participants • Data not collected for providers.
|
|
Sex: Female, Male
Male
|
—
|
393 Participants
n=412 Participants • Data not collected for providers.
|
—
|
360 Participants
n=378 Participants • Data not collected for providers.
|
753 Participants
n=790 Participants • Data not collected for providers.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
—
|
20 Participants
n=412 Participants • Data not collected for providers.
|
—
|
36 Participants
n=378 Participants • Data not collected for providers.
|
56 Participants
n=790 Participants • Data not collected for providers.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
—
|
382 Participants
n=412 Participants • Data not collected for providers.
|
—
|
336 Participants
n=378 Participants • Data not collected for providers.
|
718 Participants
n=790 Participants • Data not collected for providers.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
—
|
10 Participants
n=412 Participants • Data not collected for providers.
|
—
|
6 Participants
n=378 Participants • Data not collected for providers.
|
16 Participants
n=790 Participants • Data not collected for providers.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
—
|
1 Participants
n=412 Participants • Data not collected for providers.
|
—
|
3 Participants
n=378 Participants • Data not collected for providers.
|
4 Participants
n=790 Participants • Data not collected for providers.
|
|
Race (NIH/OMB)
Asian
|
—
|
2 Participants
n=412 Participants • Data not collected for providers.
|
—
|
4 Participants
n=378 Participants • Data not collected for providers.
|
6 Participants
n=790 Participants • Data not collected for providers.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
—
|
1 Participants
n=412 Participants • Data not collected for providers.
|
—
|
1 Participants
n=378 Participants • Data not collected for providers.
|
2 Participants
n=790 Participants • Data not collected for providers.
|
|
Race (NIH/OMB)
Black or African American
|
—
|
50 Participants
n=412 Participants • Data not collected for providers.
|
—
|
104 Participants
n=378 Participants • Data not collected for providers.
|
154 Participants
n=790 Participants • Data not collected for providers.
|
|
Race (NIH/OMB)
White
|
—
|
346 Participants
n=412 Participants • Data not collected for providers.
|
—
|
246 Participants
n=378 Participants • Data not collected for providers.
|
592 Participants
n=790 Participants • Data not collected for providers.
|
|
Race (NIH/OMB)
More than one race
|
—
|
2 Participants
n=412 Participants • Data not collected for providers.
|
—
|
5 Participants
n=378 Participants • Data not collected for providers.
|
7 Participants
n=790 Participants • Data not collected for providers.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
—
|
10 Participants
n=412 Participants • Data not collected for providers.
|
—
|
15 Participants
n=378 Participants • Data not collected for providers.
|
25 Participants
n=790 Participants • Data not collected for providers.
|
|
Region of Enrollment
United States
|
47 Participants
n=47 Participants
|
412 Participants
n=412 Participants
|
69 Participants
n=69 Participants
|
378 Participants
n=378 Participants
|
906 Participants
n=906 Participants
|
PRIMARY outcome
Timeframe: 12 months after lung cancer screening visitPopulation: Enrolled participants with complete outcome data. The overall number of participants analyzed is lower than enrolled participants due to missing survey/electronic medical records data.
The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records. This measure only applies to patient enrollees.
Outcome measures
| Measure |
Unstructured Care: Patients
n=359 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
n=322 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Self-reported Smoking Abstinence
|
50 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: Time period from lung cancer screening through 12 months after lung cancer screeningCosts of implementing smoking cessation care from lung cancer screening to 12 months post-lung cancer screening will be monitored in both the unstructured and proactive care arms. Cost of implementing smoking cessation care is defined as the sum of the cost of behavioral counseling, cost of pharmacotherapies, and cost of intervention staff effort. This measure only applies to patient enrollees.
Outcome measures
| Measure |
Unstructured Care: Patients
n=412 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
n=378 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Cost of Smoking Cessation Care
|
34.1 dollars
Standard Deviation 159.1
|
384.2 dollars
Standard Deviation 161.1
|
SECONDARY outcome
Timeframe: 3 months after lung cancer screening visitPopulation: Subset of participants in the Proactive Care arm who responded to the 3 month survey and rated their satisfaction with VA Quitline telephone counseling.
Binary variable for whether participant reported being either very satisfied or somewhat satisfied with VA Quitline telephone counseling. This measure only applies to patient enrollees in the proactive arm.
Outcome measures
| Measure |
Unstructured Care: Patients
n=98 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Patients' Experience With Telephone Counseling
|
34 Participants
|
—
|
SECONDARY outcome
Timeframe: 3 months after lung cancer screening visitPopulation: Subset of overall sample who responded to the 3 month survey and rated their motivation to quit smoking.
Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.
Outcome measures
| Measure |
Unstructured Care: Patients
n=106 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
n=97 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Patients' Motivational Assessment
|
7.54 score on a scale
Standard Deviation 3.01
|
7.95 score on a scale
Standard Deviation 3.05
|
SECONDARY outcome
Timeframe: 3 months after lung cancer screening visitPopulation: Subset of overall sample who responded to the 3 month survey and rated their perceived susceptibility to the harmful effects of smoking and perception of screening as protective.
Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective. Patients were asked 5 questions related to smoking and screening, and an overall score based on the sum of correct answers was calculated. Scores range from 0-5 (higher scores indicate greater knowledge about harmful effects of smoking and benefits of screening). This measure only applies to patient enrollees.
Outcome measures
| Measure |
Unstructured Care: Patients
n=103 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
n=91 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Patients' Perception of Susceptibility to Harm
|
1.97 score on a scale
Standard Deviation 1.11
|
2.09 score on a scale
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: 3 months after lung cancer screening visitPopulation: Subset of overall sample who responded to the 3 month survey and rated their self-efficacy for quitting smoking.
Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.
Outcome measures
| Measure |
Unstructured Care: Patients
n=100 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
n=92 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Patients' Self-efficacy Assessment
|
5.7 score on a scale
Standard Deviation 3.3
|
6.5 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 12 months after lung cancer screening visitPopulation: Subset of overall sample who responded to the 12 month survey and rated their motivation to quit smoking.
Surveys will assess patient motivation to quit smoking on a scale from 0-10 (higher scores indicate higher motivation to quit smoking). This measure only applies to patient enrollees.
Outcome measures
| Measure |
Unstructured Care: Patients
n=116 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
n=113 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Patients' Motivational Assessment
|
7.48 score on a scale
Standard Deviation 2.95
|
7.3 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 12 months after lung cancer screening visitPopulation: Subset of overall sample who responded to the 12 month survey and rated their self-efficacy for quitting smoking.
Surveys will assess patients' self-efficacy for quitting smoking on a scale from 0-10 (higher scores indicate greater self-efficacy for quitting smoking). This measure only applies to patient enrollees.
Outcome measures
| Measure |
Unstructured Care: Patients
n=117 Participants
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team.
|
Proactive Care: Patients
n=114 Participants
Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling.
Unsigned note to provider about cessation medication prescription: For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note for the provider about the recommended medication indicated by VA formulary guidelines.
Proactive Telephone Counseling from VA Quitline: Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
|
|---|---|---|
|
Patients' Self-efficacy Assessment
|
5.8 score on a scale
Standard Deviation 3.4
|
6.1 score on a scale
Standard Deviation 3.3
|
Adverse Events
Unstructured Care: Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Unstructured Care: Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Proactive Care: Providers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Proactive Care: Patients
Serious events: 0 serious events
Other events: 0 other events
Deaths: 8 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