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| Name | Class |
|---|---|
| Fred Hutchinson Cancer Center | OTHER |
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This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.
This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unstructured care | No Intervention | Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team. | |
| Proactive care | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unsigned note to provider about cessation medication prescription | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported Smoking Abstinence | 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. | 12 months after lung cancer screening visit |
| Measure | Description | Time Frame |
|---|---|---|
| Cost of Smoking Cessation Care | Costs 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven B Zeliadt, PhD MPH | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY | New York | New York | 10010-5011 | United States | ||
The investigators anticipate publishing the findings alongside other similar trials funded by NCI through the Smoking Cessation within the Context of Lung Cancer Screening (SCALE) collaboration, with journals that will likely require concurrent publication of de-identified datasets.
De-identified final datasets will be made available through publisher portals or other repositories identified by SCALE collaboration for ensuring dissemination and publication of trial findings upon completion of the study (2022). Preliminary (de-identified) datasets, study protocol, and statistical analysis plans may be made available to other researchers in the SCALE collaboration throughout the duration of the project.
Access will only be provided as necessary to allow transparency and evaluation of the results originally obtained by the Principal Investigator who generated the data or to expand upon the work. This assumes the recipient has knowledge, training and resources to adequately design and conduct the studies replicating the original work, or can otherwise determine the validity of results by reviewing the data provided.
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Unstructured Care: Patients |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2021 | Feb 8, 2024 |
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| Proactive Telephone Counseling from VA Quitline | Behavioral | 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. |
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| Time period from lung cancer screening through 12 months after lung cancer screening |
| Patients' Experience With 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. | 3 months after lung cancer screening visit |
| Patients' Motivational Assessment | 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. | 3 months after lung cancer screening visit |
| Patients' Perception of Susceptibility to Harm | 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. | 3 months after lung cancer screening visit |
| Patients' Self-efficacy Assessment | 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. | 3 months after lung cancer screening visit |
| Patients' Motivational Assessment | 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. | 12 months after lung cancer screening visit |
| Patients' Self-efficacy Assessment | 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. | 12 months after lung cancer screening visit |
| Providence VA Medical Center, Providence, RI |
| Providence |
| Rhode Island |
| 02908-4734 |
| United States |
| VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington | 98108-1532 | United States |
Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team. |
| FG002 | 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. |
| FG003 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | 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. 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. |
| BG003 | 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 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data not collected for providers. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Data not collected for providers. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Data not collected for providers. | Count of Participants | Participants |
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| Race (NIH/OMB) | Data not collected for providers. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Self-reported Smoking Abstinence | 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. | 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. | Posted | Count of Participants | Participants | 12 months after lung cancer screening visit |
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| Secondary | Cost of Smoking Cessation Care | Costs 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. | Posted | Mean | Standard Deviation | dollars | Time period from lung cancer screening through 12 months after lung cancer screening |
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| Secondary | Patients' Experience With 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. | Subset of participants in the Proactive Care arm who responded to the 3 month survey and rated their satisfaction with VA Quitline telephone counseling. | Posted | Count of Participants | Participants | 3 months after lung cancer screening visit |
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| Secondary | Patients' Motivational Assessment | 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. | Subset of overall sample who responded to the 3 month survey and rated their motivation to quit smoking. | Posted | Mean | Standard Deviation | score on a scale | 3 months after lung cancer screening visit |
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| Secondary | Patients' Perception of Susceptibility to Harm | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months after lung cancer screening visit |
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| Secondary | Patients' Self-efficacy Assessment | 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. | Subset of overall sample who responded to the 3 month survey and rated their self-efficacy for quitting smoking. | Posted | Mean | Standard Deviation | score on a scale | 3 months after lung cancer screening visit |
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| Secondary | Patients' Motivational Assessment | 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. | Subset of overall sample who responded to the 12 month survey and rated their motivation to quit smoking. | Posted | Mean | Standard Deviation | score on a scale | 12 months after lung cancer screening visit |
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| Secondary | Patients' Self-efficacy Assessment | 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. | Subset of overall sample who responded to the 12 month survey and rated their self-efficacy for quitting smoking. | Posted | Mean | Standard Deviation | score on a scale | 12 months after lung cancer screening visit |
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1 year following LCS date
All-cause mortality during the 1 year period following LCS was assessed for all patients (providers not assessed). Serious and other non-serious adverse events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 7 | 422 | 0 | 0 | 0 | 0 |
| EG002 | 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. 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 seen by these providers who receive lung cancer screening will be assigned to the proactive care arm. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | 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. | 8 | 406 | 0 | 0 | 0 | 0 |
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We originally planned to base our smoking cessation outcome on biochemically-confirmed 7-day smoking abstinence. Due to the COVID-19 pandemic, it was not possible to perform the saliva cotinine testing needed for biochemically confirmed abstinence, and no biochemical data were collected. Instead, we updated our study protocol to use a combination of survey and electronic medical record data to determine smoking status at 12 months post-lung cancer screening as our primary outcome.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steven B Zeliadt | VA Puget Sound Health Care System | 206-277-4175 | Steven.Zeliadt@va.gov |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2023 | Feb 12, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000074264 | Smoking Reduction |
| D064424 | Tobacco Use |
| D000073869 | Tobacco Smoking |
| D008171 | Lung Diseases |
| D008175 | Lung Neoplasms |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D012907 | Smoking |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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