Lung Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALPatient education
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.
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.
BEHAVIORALPatient Reminders
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.
BEHAVIORALProvider Reminers
Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.
Sponsors
University of California, Irvine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Patients' Inclusion Criteria: 1. Aged 50- 80 years of age. 2. Be able to Speak English, Spanish, or Vietnamese 3. Must have a scheduled appointment with their Primary Care Providers within next one to three months. 4. The Scheduled PCP appointment is at any of the UCI Health primary care clinics in Orange County including two UCI federally qualified health centers 5. History of 20 pack year smoking history ( based on survey self report) 6. Current smoker or a former smoker who has quit smoking within the last 15 years (based on survey self report) Patients'
Exclusion criteria
1. Prior history of lung cancer 2. chest CT for any reason in the last 12 months based on self-report and UCI EMR 3. history of Alzheimer's disease or dementia Providers' Inclusion Criteria: 1. Primary Care Providers whose patients were enrolled in the Empower LCS trial. 2. Received notifications about the eligibility of their patients for lung cancer screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Order of LDCT | within 6 months of enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of LDCT | Within 6 months of enrollment | 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. |
| LCS Discussion | within 6 months after enrollment | 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. |
| Perceived Risk of Lung Cancer | At 6 months post-enrollment | 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. |
| Perceived Severity of Lung Cancer | At 6 months post-enrollment | 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. |
| Perceived Benefit of Lung Cancer Screening | At 6 months post-enrollment | 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. |
| Perceived Barriers to Lung Cancer Screening | At 6 months post-enrollment | 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. |
| Perceived Self-efficacy for Lung Cancer Screening | At 6 months post-enrollment | 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. |
| Knowledge About Lung Cancer and Screening | At 6 months post-enrollment | 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. |
| Providers' Perceived Barriers to Lung Cancer Screening | Baseline | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGelareh Sadigh, MD
University of California, Irvine
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized Age 50-59 yrs old | 2 Participants |
| Age, Customized Age <50 yrs old | 0 Participants |
| Age, Customized Age 60-69 yrs old | 1 Participants |
| Age, Customized Age +70 yrs old | 9 Participants |
| Perceived barriers of LCS | 40.7 scores on a scale STANDARD_DEVIATION 14.4 |
| Perceived benefits of LCS | 24.6 scores on a scale STANDARD_DEVIATION 3.5 |
| Perceived Knowledge of LCS | 1.9 scores on a scale STANDARD_DEVIATION 1 |
| Perceived risk of lung cancer | 9.9 scores on a scale STANDARD_DEVIATION 3 |
| Perceived severity of lung cancer | 16.3 scores on a scale STANDARD_DEVIATION 2.7 |
| Race/Ethnicity, Customized Race Asian | 5 Participants |
| Race/Ethnicity, Customized Race Black | 0 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants |
| Race/Ethnicity, Customized Race White | 33 Participants |
| Region of Enrollment United States | 9 Participants |
| Self- efficacy for LCS | 40.4 scores on a scale STANDARD_DEVIATION 6.3 |
| Sex/Gender, Customized Sex Female | 0 Participants |
| Sex/Gender, Customized Sex Male | 50 Participants |
| Sex/Gender, Customized Sex Unknown/not collected | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 9 |
| other Total, other adverse events | 0 / 70 | 0 / 9 |
| serious Total, serious adverse events | 0 / 70 | 0 / 9 |
Outcome results
None listed