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| ID | Type | Description | Link |
|---|---|---|---|
| U54GM104941 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Thomas Jefferson University | OTHER |
| University of Delaware | OTHER |
| National Institute of General Medical Sciences (NIGMS) | NIH |
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Lung cancer screening rates are very low despite the fact that lung cancer screening could save many lives. People need to understand the risks and benefits to screening as well as their own beliefs about screening. This study builds an intervention in real world primary care that will help people make the right decision for them as well as help people to quit smoking. Interventions like this are needed to improve the screening rate and reduce death from lung cancer, which is the leading cancer killer.
Lung cancer screening rates in the United States are very low- just 3.3% in 2010 and 3.9% in 2015. There is a critical need to develop and implement effective strategies to engage high-risk patients in a coordinated program of lung cancer screening, which includes shared-decision making. The investigators proposed to modify and expand a shared decision- counseling intervention previously developed in one primary care practice. The investigators measured lung cancer screening in our intervention group compared to a propensity-matched usual care cohort. The investigators compared patients recruited to patients who are not in order to identify potential sources of disparity in future work and the investigators developed a more intense smoking cessation component. Model interventions for shared-decision making in clinical practice are needed across a wide range of diseases and decisions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phone-delivered decision-counseling program for shared decision making in lung cancer screening | Experimental | All individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision Making | Behavioral | Telephone delivered non-persuasive shared decision-making for lung cancer screening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Received a Low Dose CT Scan of the Chest | Percentage of individuals who have evidence of a low-dose CT scan of the chest in their electronic medical record at 1 year post intervention, as ascertained by chart audit by research assistance. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heather B Fagan, MD | Christiana Care Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christiana Care Health System | Newark | Delaware | 19718 | United States |
Pending data analytic support to de-identify data, will share entire study data.
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We identified 1359 individuals in our electronic medical record data who appeared to be current smokers within the age range of 55-78 years old. From this group, 1073 remained potentially eligible after chart review. From this group, 336 were reached by phone. From this group, 80 individuals were eligible and consented to be in our study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer Screening | All individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group. Shared Decision Making: Telephone delivered non-persuasive shared decision-making for lung cancer screening. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer Screening | All individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group. Shared Decision Making: Telephone delivered non-persuasive shared decision-making for lung cancer screening. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients Who Received a Low Dose CT Scan of the Chest | Percentage of individuals who have evidence of a low-dose CT scan of the chest in their electronic medical record at 1 year post intervention, as ascertained by chart audit by research assistance. | Posted | Count of Participants | Participants | 1 year |
|
1 year measured from the date of patient enrollment
Serious adverse event, all-cause mortality, and other serious events were zero because lung cancer screening is part of standard clinical care. There were no adverse events within the course of this study.
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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 | Phone-delivered Decision-counseling Program for Shared Decision Making in Lung Cancer Screening | All individuals who are eligible for lung cancer screening according to USPSTF criteria were invited to participate in the study and all patients who accepted the invitation and consented were slated to receive the intervention which was a phone-delivered on line decision-counseling program (DCP) and there was no one randomized or enrolled into a control group, nor was anyone randomized or enrolled into a usual care group. Shared Decision Making: Telephone delivered non-persuasive shared decision-making for lung cancer screening. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Bittner Fagan, MD MPH | Christiana Care Health System | 302 320 4110 | hbittner-fagan@christianacare.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 31, 2012 | Jul 18, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 18, 2018 | Sep 6, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| pack-years | It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. | Mean | Standard Deviation | (packs/day)*years |
|
|
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| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |