Empower-LCS: Empowering Patients' Lung Cancer Screening Uptake

Sponsor
University of California, Irvine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06000683
Collaborator
(none)
80
1
16

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient education
  • Behavioral: Referral to financial navigation resources
  • Behavioral: Patient Reminders
  • Behavioral: Provider Reminers
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Empower LCS

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.

Behavioral: Patient 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.

Behavioral: Referral to financial navigation resources
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.

Behavioral: Patient 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.

Behavioral: Provider Reminers
Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.

Outcome Measures

Primary Outcome Measures

  1. Order of LDCT [within 6 months of enrollment]

    Primary end point is order of LDCT within 6 months after enrollment assessed with self-reported surveys and EMR data extraction.

Secondary Outcome Measures

  1. Perceived Risk of lung cancer [at baseline and 6 month post enrollment]

    self reported in survey

  2. Perceived Severity of lung cancer [at baseline and 6 month post enrollment]

    self reported in survey

  3. Perceived Benefit of lung cancer screening [at baseline and 6 month post enrollment]

    self reported in survey

  4. Perceived barriers lung cancer screening [at baseline and 6 month post enrollment]

    self reported in survey

  5. Self-efficacy for lung cancer screening [at baseline and 6 month post enrollment]

    self reported in survey

  6. Knowledge about lung cancer and screening [at baseline and 6 month post enrollment]

    self reported in survey

  7. LCS discussion [within 6 months after enrollment]

    Patient and Primary Care Provider discussing lung cancer screening

  8. Receipt of LDCT [Within 6 months of enrollment]

    A receipt of LDCT for LCS will be checked either through self reported or EMR

  9. Providers' Perceived barriers [within 3 month after last patient enrolled]

    Provider will be asked about perceived barriers and knowledge of Lung cancer screening though a survey

Other Outcome Measures

  1. Patient and provider experience with intervention [At the end of all study enrollments a subgroup of patients and providers will be interviewed]

    Patient and Providers will be asked questions about their experience with intervention components interview

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 with in 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)

Exclusion Criteria:

1 No prior history of lung cancer 2, No chest CT for any reason in the last 12 months based on self-report and UCI EMR 3,No history of Alzheimer's disease or dementia

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, Irvine

Investigators

  • Principal Investigator: Gelareh Sadigh, MD, University of California, Irvine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gelareh Sadigh, Associate Professor In Residence, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT06000683
Other Study ID Numbers:
  • IRB#3439
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2023