Trial Outcomes & Findings for Empowering Patients' Lung Cancer Screening Uptake (NCT NCT06000683)
NCT ID: NCT06000683
Last Updated: 2026-02-03
Results Overview
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.
COMPLETED
NA
79 participants
within 6 months of enrollment
2026-02-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
Provider Participants
Primary care providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
9
|
|
Overall Study
COMPLETED
|
70
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This variable is only measured for patient participants.
Baseline characteristics by cohort
| Measure |
Patient Participants
n=70 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.
|
Provider Participants
n=9 Participants
Primary care providers taking care of Empower LCS patient participants
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Region of Enrollment
United States
|
70 Participants
n=70 Participants
|
9 Participants
n=9 Participants
|
79 Participants
n=79 Participants
|
|
Perceived risk of lung cancer
|
9.9 scores on a scale
STANDARD_DEVIATION 3 • n=70 Participants • This variable is only measured for patient participants.
|
—
|
9.9 scores on a scale
STANDARD_DEVIATION 3 • n=70 Participants • This variable is only measured for patient participants.
|
|
Perceived severity of lung cancer
|
16.3 scores on a scale
STANDARD_DEVIATION 2.7 • n=70 Participants • This variable is only measured for patient participants.
|
—
|
16.3 scores on a scale
STANDARD_DEVIATION 2.7 • n=70 Participants • This variable is only measured for patient participants.
|
|
Perceived benefits of LCS
|
24.6 scores on a scale
STANDARD_DEVIATION 3.5 • n=70 Participants • This variable is only measured for patient participants.
|
—
|
24.6 scores on a scale
STANDARD_DEVIATION 3.5 • n=70 Participants • This variable is only measured for patient participants.
|
|
Perceived barriers of LCS
|
40.7 scores on a scale
STANDARD_DEVIATION 14.4 • n=70 Participants • This variable is only measured for patient participants.
|
—
|
40.7 scores on a scale
STANDARD_DEVIATION 14.4 • n=70 Participants • This variable is only measured for patient participants.
|
|
Self- efficacy for LCS
|
40.4 scores on a scale
STANDARD_DEVIATION 6.3 • n=70 Participants • This variable is only measured for patient participants.
|
—
|
40.4 scores on a scale
STANDARD_DEVIATION 6.3 • n=70 Participants • This variable is only measured for patient participants.
|
|
Perceived Knowledge of LCS
|
1.9 scores on a scale
STANDARD_DEVIATION 1 • n=70 Participants • This variable is only measured for patient participants.
|
—
|
1.9 scores on a scale
STANDARD_DEVIATION 1 • n=70 Participants • This variable is only measured for patient participants.
|
|
Sex/Gender, Customized
Sex · Male
|
50 Participants
n=70 Participants
|
0 Participants
n=9 Participants
|
50 Participants
n=79 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
20 Participants
n=70 Participants
|
0 Participants
n=9 Participants
|
20 Participants
n=79 Participants
|
|
Sex/Gender, Customized
Sex · Unknown/not collected
|
0 Participants
n=70 Participants
|
9 Participants
n=9 Participants
|
9 Participants
n=79 Participants
|
|
Age, Customized
Age · <50 yrs old
|
0 Participants
n=70 Participants
|
6 Participants
n=9 Participants
|
6 Participants
n=79 Participants
|
|
Age, Customized
Age · 50-59 yrs old
|
21 Participants
n=70 Participants
|
2 Participants
n=9 Participants
|
23 Participants
n=79 Participants
|
|
Age, Customized
Age · 60-69 yrs old
|
40 Participants
n=70 Participants
|
1 Participants
n=9 Participants
|
41 Participants
n=79 Participants
|
|
Age, Customized
Age · +70 yrs old
|
9 Participants
n=70 Participants
|
0 Participants
n=9 Participants
|
9 Participants
n=79 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
13 Participants
n=70 Participants
|
5 Participants
n=9 Participants
|
18 Participants
n=79 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=70 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=79 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
25 Participants
n=70 Participants
|
2 Participants
n=9 Participants
|
27 Participants
n=79 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
31 Participants
n=70 Participants
|
2 Participants
n=9 Participants
|
33 Participants
n=79 Participants
|
PRIMARY outcome
Timeframe: within 6 months of enrollmentPopulation: The outcome is being reported among all 70 enrolled patient participants based on data available through 6-months follow-up survey or EMR.
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.
Outcome measures
| Measure |
Patient Participants
n=70 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Order of LDCT
|
50 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 6 months of enrollmentPopulation: The outcome is being reported among all 70 enrolled patient participants based on data available through 6-months follow-up survey or EMR.
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.
Outcome measures
| Measure |
Patient Participants
n=70 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Receipt of LDCT
|
17 Participants
|
—
|
SECONDARY outcome
Timeframe: within 6 months after enrollmentPopulation: The outcome is being reported among all 70 enrolled patient participants based on data available through 6-months follow-up survey or EMR.
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.
Outcome measures
| Measure |
Patient Participants
n=70 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
LCS Discussion
|
43 Participants
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-enrollmentPopulation: This outcome is measured only among participants who completed the 6-months follow-up survey.
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.
Outcome measures
| Measure |
Patient Participants
n=42 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Perceived Risk of Lung Cancer
|
10.1 scores on a scale
Standard Deviation 3
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-enrollmentPopulation: This outcome is measured only among participants who completed the 6-months follow-up survey.
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.
Outcome measures
| Measure |
Patient Participants
n=42 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Perceived Severity of Lung Cancer
|
18.1 scores on a scale
Standard Deviation 3.1
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-enrollmentPopulation: This outcome is measured only among participants who completed the 6-months follow-up survey.
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.
Outcome measures
| Measure |
Patient Participants
n=42 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Perceived Benefit of Lung Cancer Screening
|
24.7 scores on a scale
Standard Deviation 4.7
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-enrollmentPopulation: This outcome is measured only among participants who completed the 6-months follow-up survey.
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.
Outcome measures
| Measure |
Patient Participants
n=42 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Perceived Barriers to Lung Cancer Screening
|
37.5 scores on a scale
Standard Deviation 15.6
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-enrollmentPopulation: This outcome is measured only among participants who completed the 6-months follow-up survey.
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.
Outcome measures
| Measure |
Patient Participants
n=42 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Perceived Self-efficacy for Lung Cancer Screening
|
41.7 scores on a scale
Standard Deviation 7.5
|
—
|
SECONDARY outcome
Timeframe: At 6 months post-enrollmentPopulation: This outcome is measured only among participants who completed the 6-months follow-up survey.
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.
Outcome measures
| Measure |
Patient Participants
n=42 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Knowledge About Lung Cancer and Screening
|
2.7 scores on a scale
Standard Deviation 1.6
|
—
|
SECONDARY outcome
Timeframe: Baseline9-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.
Outcome measures
| Measure |
Patient Participants
n=9 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.
|
Primary Care Providers
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Providers' Perceived Barriers to Lung Cancer Screening
|
24.1 Score on a scale
Standard Deviation 4.2
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the end of all study enrollments a subgroup of patients and providers were interviewedPopulation: A subsample of patients and providers were recruited to participate in qualitative interviews. Each row summarizes a theme identified in thematic analysis. The number of participants that endorsed/discussed the theme are reported.
Patient and Providers were asked questions about their experience with intervention components. Outcomes
Outcome measures
| Measure |
Patient Participants
n=11 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.
|
Primary Care Providers
n=5 Participants
Providers taking care of Empower LCS patient participants
|
|---|---|---|
|
Patient and Provider Experience With Intervention
Shared Negative Views of Current Lung Cancer Screening Protocols
|
3 Participants
|
4 Participants
|
|
Patient and Provider Experience With Intervention
Identified Barriers to Lung Cancer Screening
|
6 Participants
|
5 Participants
|
|
Patient and Provider Experience With Intervention
Provided Suggestions for Future Trials
|
8 Participants
|
4 Participants
|
|
Patient and Provider Experience With Intervention
Shared Impact of Intervention
|
8 Participants
|
5 Participants
|
|
Patient and Provider Experience With Intervention
Shared Positive Views of Current Lung Cancer Screening Protocols
|
4 Participants
|
2 Participants
|
Adverse Events
Patient Participants
Provider Participants
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