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| ID | Type | Description | Link |
|---|---|---|---|
| UCI 23-107 | Other Identifier | University of California Irvine IRB |
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Lung cancer is the leading cause of cancer related mortality. Lung cancer screening (LCS) with low dose computed tomography (LDCT) decreases mortality rate of lung cancer by 20%. Yet many patients who are eligible for lung cancer screening are still falling through the cracks which prevents patients the ability to detect lung cancer early. This study will test the effect of a a multi-level intervention on ordering LDCT within 6 months after patient enrollment. Our proposed intervention includes (1) Primary care provider notifications of patients' LCS eligibility; (2) patients' education ; (3) patients' referral to financial navigation resources; and (4) patients' reminder to discuss LCS during PCP visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empower LCS | Experimental | Patient will be given education material(addressing knowledge barriers); patients' referral to financial navigation resources (addressing health-related social risks); and patients' reminder to discuss LCS during PCP visit. Providers will also be notified of eligibility of their patients to receive LCS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient education | Behavioral | Patients will be sent information (in preferred language) on lung cancer risk, lung cancer screening (LCS) benefits, harms, false positive rates, recommendations of follow-up for positive results, and exam insurance coverage. |
| Measure | Description | Time Frame |
|---|---|---|
| Order of LDCT | Number of participants who were ordered screening with Low Dose Computed Tomographyorder (LDCT) within 6 months after enrollment, assessed with self-reported surveys or EMR data extraction. | within 6 months of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Receipt of LDCT | Number of participants who were completed screening with Low Dose Computed Tomographyorder (LDCT) within 6 months after enrollment, assessed with self-reported surveys or EMR data extraction. | Within 6 months of enrollment |
| LCS Discussion |
| Measure | Description | Time Frame |
|---|---|---|
| Patient and Provider Experience With Intervention | Patient and Providers were asked questions about their experience with intervention components. Outcomes | At the end of all study enrollments a subgroup of patients and providers were interviewed |
Patients' Inclusion Criteria:
Patients' Exclusion Criteria:
Providers' Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gelareh Sadigh, MD | University of California, Irvine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCI Health - Costa Mesa | Costa Mesa | California | 92627 | United States | ||
| UCI Health Gottschalk Medical Plaza |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41904093 | Derived | Sharifian M, Hoyt MA, Madan A, Lee S, Nguyen TQ, Sadigh G. Patients' and Providers' Perspective of a Multi-level Approach to Improve Participation in Low-dose CT for Lung Cancer Screening (Empower LCS): A Mixed-Methods Analysis. Acad Radiol. 2026 Jun;33(6):2352-2360. doi: 10.1016/j.acra.2026.03.014. Epub 2026 Mar 28. | |
| 41241060 | Derived |
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Protocol enrollment reflects the 70 patient participants of the study who consented to study and received study intervention.
We further reached out to primary care providers of patient participants, and 9 providers consented to study and completed a survey.
Patients were recruited via email, phone, mail or in-person outreach. 70 eligible patients consented to study and were enrolled.
Primary care providers taking care of patient participants were recruited via email outreach. A total of 9 provider consented to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Participants | All patients received the Empower LCS intervention, including: (1) a decision aid; (2) text reminder to encourage LCS discussion with primary care providers (PCPs); (3) PCP notifications on eligibility and barriers, and (4) financial hardship and health-related social needs support. |
| FG001 | Provider Participants | Primary care providers taking care of Empower LCS patient participants |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Participants | All patients received the Empower LCS intervention, including: (1) a decision aid; (2) text reminder to encourage LCS discussion with primary care providers (PCPs); (3) PCP notifications on eligibility and barriers, and (4) financial hardship and health-related social needs support. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Region of Enrollment | Count of Participants |
| 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 | Order of LDCT | Number of participants who were ordered screening with Low Dose Computed Tomographyorder (LDCT) within 6 months after enrollment, assessed with self-reported surveys or EMR data extraction. | The outcome is being reported among all 70 enrolled patient participants based on data available through 6-months follow-up survey or EMR. | Posted | Count of Participants | Participants | within 6 months of enrollment |
|
From enrollment until end of follow-up, up to 6 months
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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 | Patient Participants | All patients received the Empower LCS intervention, including: (1) a decision aid; (2) text reminder to encourage LCS discussion with primary care providers (PCPs); (3) PCP notifications on eligibility and barriers, and (4) financial hardship and health-related social needs support. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gelareh Sadigh, MD | University of California Irvine | (714) 456-3610 | gsadigh@hs.uci.edu |
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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 | Oct 2, 2024 | Nov 27, 2025 | Prot_SAP_000.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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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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Patient participants (n=70) will receive the study intervention, complete surveys and a subset of them (n=11) will participate in a one-time qualitative interview.
Provider participants (n=9) will not receive any intervention. Provider participants will participate in a one-time survey, and a subset of them (n=5) will participate in a one-time qualitative interview.
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| Referral to financial navigation resources | Behavioral | Patients who self-report needing help with health-related social risks at baseline will be sent a brochure (in preferred language) from patient advocate foundation (PAF), a national non-profit financial navigation organization, where patients can self-refer. |
|
| Patient Reminders | Behavioral | Within 2 weeks prior to primary care appointment, patients will receive a text message or a phone call (if not having a phone that receives text messaging) encouraging patients to discuss the LCS with their provider. |
|
| Provider Reminers | Behavioral | Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS. |
|
Number of participants who had a discussion about screening with Low Dose Computed Tomographyorder (LDCT) with their primary care provider measured within 6 months after enrollment, through self-reported surveys or EMR documentation of discussion in the primary care notes. |
| within 6 months after enrollment |
| Perceived Risk of Lung Cancer | 3-item validated survey questions (from Carter Harris et al) assessing patients' perceived risk of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 3-15. Higher score= higher perceived risk of lung cancer. | At 6 months post-enrollment |
| Perceived Severity of Lung Cancer | 5-item validated survey questions assessing patients' perceived severity of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-25. Higher score= higher perceived severity of lung cancer. | At 6 months post-enrollment |
| Perceived Benefit of Lung Cancer Screening | 6-item validated survey questions (from Carter Harris et al) assessing patients' perceived benefits of lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 6-30. Higher score= higher perceived benefits of lung cancer screening. | At 6 months post-enrollment |
| Perceived Barriers to Lung Cancer Screening | 19-item validated survey questions (from Carter Harris et al) assessing patients' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 19-95. Higher score= higher perceived barriers to lung cancer screening. | At 6 months post-enrollment |
| Perceived Self-efficacy for Lung Cancer Screening | 10-item validated survey questions (from Carter Harris et al) assessing patients' perceived self-efficacy to undergo lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-50. Higher score= higher perceived self-efficacy. | At 6 months post-enrollment |
| Knowledge About Lung Cancer and Screening | Knowledge of lung cancer and LCS was assessed using 8-items validated questions (from Volk et al), and scored by awarding one point per correct answer selected and one point per incorrect answer not selected. The total score was calculated as sum of all points. Total score ranged between 0 to 8. Higher score= higher knowledge. | At 6 months post-enrollment |
| Providers' Perceived Barriers to Lung Cancer Screening | 9-item survey questions assessing providers' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 9-45. Higher score= higher perceived barriers to lung cancer screening. | Baseline |
| Irvine |
| California |
| 92697 |
| United States |
| UCI Health - Laguna Hills | Laguna Hills | California | 92653 | United States |
| UCI Health - Newport Beach MacArthur | Newport Beach | California | 92660 | United States |
| UCI Medical Center | Orange | California | 92868 | United States |
| UCI Health - Tustin | Tustin | California | 92670 | United States |
| UCI Health-Yorba Linda | Yorba Linda | California | 92886 | United States |
| Shojazadeh A, Kao R, Pham T, Madan A, Echeverria R, Chen WP, Nguyen V, Gutierrez O, Lee S, Hoyt MA, Ziogas A, Nguyen TQ, Keshava H, Sadigh G. A Multilevel Approach to Improve Participation in Low-Dose CT for Lung Cancer Screening (Empower LCS): A Single-Arm Pilot Feasibility Clinical Trial. J Am Coll Radiol. 2026 Apr;23(4):556-564. doi: 10.1016/j.jacr.2025.11.005. Epub 2025 Nov 13. |
| Provider Participants |
Primary care providers taking care of Empower LCS patient participants |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Perceived risk of lung cancer | 3-item question with responses using 5-point Likert scale (score range: 3-15); higher score = higher perceived risk of lung cancer | This variable is only measured for patient participants. | Mean | Standard Deviation | scores on a scale |
|
| Perceived severity of lung cancer | 5-item question with responses using 5-point Likert scale (score range: 5-25); higher score = higher perceived severity of lung cancer | This variable is only measured for patient participants. | Mean | Standard Deviation | scores on a scale |
|
| Perceived benefits of LCS | 6-item question with responses using 5-point Likert scale (score range: 6-30); higher score = higher perceived benefits of LCS | This variable is only measured for patient participants. | Mean | Standard Deviation | scores on a scale |
|
| Perceived barriers of LCS | 19-item question with responses using 5-point Likert scale (score range: 19-95); higher score = higher perceived barriers of LCS | This variable is only measured for patient participants. | Median | Standard Deviation | scores on a scale |
|
| Self- efficacy for LCS | 10-item question with responses using 5-point Likert scale (score range: 10-50); higher score = higher perceived self-efficacy for LCS | This variable is only measured for patient participants. | Mean | Standard Deviation | scores on a scale |
|
| Perceived Knowledge of LCS | 8-item question scored by awarding one point per correct answer selected and one point per incorrect answer not selected. The score was calculated as sum of all points (score range 0-8); higher score = higher knowledge of LCS | This variable is only measured for patient participants. | Mean | Standard Deviation | scores on a scale |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Age, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Receipt of LDCT | Number of participants who were completed screening with Low Dose Computed Tomographyorder (LDCT) within 6 months after enrollment, assessed with self-reported surveys or EMR data extraction. | The outcome is being reported among all 70 enrolled patient participants based on data available through 6-months follow-up survey or EMR. | Posted | Count of Participants | Participants | Within 6 months of enrollment |
|
|
|
| Secondary | LCS Discussion | Number of participants who had a discussion about screening with Low Dose Computed Tomographyorder (LDCT) with their primary care provider measured within 6 months after enrollment, through self-reported surveys or EMR documentation of discussion in the primary care notes. | The outcome is being reported among all 70 enrolled patient participants based on data available through 6-months follow-up survey or EMR. | Posted | Count of Participants | Participants | within 6 months after enrollment |
|
|
|
| Secondary | Perceived Risk of Lung Cancer | 3-item validated survey questions (from Carter Harris et al) assessing patients' perceived risk of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 3-15. Higher score= higher perceived risk of lung cancer. | This outcome is measured only among participants who completed the 6-months follow-up survey. | Posted | Mean | Standard Deviation | scores on a scale | At 6 months post-enrollment |
|
|
|
| Secondary | Perceived Severity of Lung Cancer | 5-item validated survey questions assessing patients' perceived severity of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-25. Higher score= higher perceived severity of lung cancer. | This outcome is measured only among participants who completed the 6-months follow-up survey. | Posted | Mean | Standard Deviation | scores on a scale | At 6 months post-enrollment |
|
|
|
| Secondary | Perceived Benefit of Lung Cancer Screening | 6-item validated survey questions (from Carter Harris et al) assessing patients' perceived benefits of lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 6-30. Higher score= higher perceived benefits of lung cancer screening. | This outcome is measured only among participants who completed the 6-months follow-up survey. | Posted | Mean | Standard Deviation | scores on a scale | At 6 months post-enrollment |
|
|
|
| Secondary | Perceived Barriers to Lung Cancer Screening | 19-item validated survey questions (from Carter Harris et al) assessing patients' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 19-95. Higher score= higher perceived barriers to lung cancer screening. | This outcome is measured only among participants who completed the 6-months follow-up survey. | Posted | Mean | Standard Deviation | scores on a scale | At 6 months post-enrollment |
|
|
|
| Secondary | Perceived Self-efficacy for Lung Cancer Screening | 10-item validated survey questions (from Carter Harris et al) assessing patients' perceived self-efficacy to undergo lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-50. Higher score= higher perceived self-efficacy. | This outcome is measured only among participants who completed the 6-months follow-up survey. | Posted | Mean | Standard Deviation | scores on a scale | At 6 months post-enrollment |
|
|
|
| Secondary | Knowledge About Lung Cancer and Screening | Knowledge of lung cancer and LCS was assessed using 8-items validated questions (from Volk et al), and scored by awarding one point per correct answer selected and one point per incorrect answer not selected. The total score was calculated as sum of all points. Total score ranged between 0 to 8. Higher score= higher knowledge. | This outcome is measured only among participants who completed the 6-months follow-up survey. | Posted | Mean | Standard Deviation | scores on a scale | At 6 months post-enrollment |
|
|
|
| Secondary | Providers' Perceived Barriers to Lung Cancer Screening | 9-item survey questions assessing providers' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 9-45. Higher score= higher perceived barriers to lung cancer screening. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
|
|
|
| Other Pre-specified | Patient and Provider Experience With Intervention | Patient and Providers were asked questions about their experience with intervention components. Outcomes | A subsample of patients and providers were recruited to participate in qualitative interviews. Each row summarizes a theme identified in thematic analysis. As this table reflects qualitative thematic analysis, cell counts represent the number of individuals whose interviews contained content corresponding to each theme. Themes were coded inductively and were not designed to be mutually exclusive or collectively exhaustive. Totals may not sum to the overall number of participants analyzed. | Posted | Count of Participants | Participants | At the end of all study enrollments a subgroup of patients and providers were interviewed |
|
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|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Provider Participants | Primary care providers taking care of Empower LCS patient participants | 0 | 9 | 0 | 9 | 0 | 9 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Unknown/not collected |
|
| 60-69 yrs old |
|
| +70 yrs old |
|
| Other |
|
| White |
|
| Identified Barriers to Lung Cancer Screening |
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| Shared Impact of Intervention |
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| Provided Suggestions for Future Trials |
|