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Empowering Patients' Lung Cancer Screening Uptake (Empower-LCS)

Primary Purpose

Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient education
Referral to financial navigation resources
Patient Reminders
Provider Reminers
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 50- 80 years of age. Be able to Speak English, Spanish, or Vietnamese Must have a scheduled appointment with their Primary Care Providers within next one to three months. The Scheduled PCP appointment is at any of the UCI Health primary care clinics in Orange County including two UCI federally qualified health centers History of 20 pack year smoking history ( based on survey self report) 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

Sites / Locations

  • UCI Health - Costa MesaRecruiting
  • UCI Health Gottschalk Medical PlazaRecruiting
  • UCI Health - Laguna HillsRecruiting
  • UCI Health - Newport Beach MacArthurRecruiting
  • UCI Medical CenterRecruiting
  • UCI Health - TustinRecruiting
  • UCI Health-Yorba LindaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Empower LCS

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Perceived Risk of lung cancer
self reported in survey
Perceived Severity of lung cancer
self reported in survey
Perceived Benefit of lung cancer screening
self reported in survey
Perceived barriers lung cancer screening
self reported in survey
Self-efficacy for lung cancer screening
self reported in survey
Knowledge about lung cancer and screening
self reported in survey
LCS discussion
Patient and Primary Care Provider discussing lung cancer screening
Receipt of LDCT
A receipt of LDCT for LCS will be checked either through self reported or EMR
Providers' Perceived barriers
Provider will be asked about perceived barriers and knowledge of Lung cancer screening though a survey

Full Information

First Posted
August 14, 2023
Last Updated
October 23, 2023
Sponsor
University of California, Irvine
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1. Study Identification

Unique Protocol Identification Number
NCT06000683
Brief Title
Empowering Patients' Lung Cancer Screening Uptake
Acronym
Empower-LCS
Official Title
Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 13, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empower LCS
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Referral to financial navigation resources
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Reminders
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Provider Reminers
Intervention Description
Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.
Primary Outcome Measure Information:
Title
Order of LDCT
Description
Primary end point is order of LDCT within 6 months after enrollment assessed with self-reported surveys and EMR data extraction.
Time Frame
within 6 months of enrollment
Secondary Outcome Measure Information:
Title
Perceived Risk of lung cancer
Description
self reported in survey
Time Frame
at baseline and 6 month post enrollment
Title
Perceived Severity of lung cancer
Description
self reported in survey
Time Frame
at baseline and 6 month post enrollment
Title
Perceived Benefit of lung cancer screening
Description
self reported in survey
Time Frame
at baseline and 6 month post enrollment
Title
Perceived barriers lung cancer screening
Description
self reported in survey
Time Frame
at baseline and 6 month post enrollment
Title
Self-efficacy for lung cancer screening
Description
self reported in survey
Time Frame
at baseline and 6 month post enrollment
Title
Knowledge about lung cancer and screening
Description
self reported in survey
Time Frame
at baseline and 6 month post enrollment
Title
LCS discussion
Description
Patient and Primary Care Provider discussing lung cancer screening
Time Frame
within 6 months after enrollment
Title
Receipt of LDCT
Description
A receipt of LDCT for LCS will be checked either through self reported or EMR
Time Frame
Within 6 months of enrollment
Title
Providers' Perceived barriers
Description
Provider will be asked about perceived barriers and knowledge of Lung cancer screening though a survey
Time Frame
within 3 month after last patient enrolled
Other Pre-specified Outcome Measures:
Title
Patient and provider experience with intervention
Description
Patient and Providers will be asked questions about their experience with intervention components interview
Time Frame
At the end of all study enrollments a subgroup of patients and providers will be interviewed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 50- 80 years of age. Be able to Speak English, Spanish, or Vietnamese Must have a scheduled appointment with their Primary Care Providers within next one to three months. The Scheduled PCP appointment is at any of the UCI Health primary care clinics in Orange County including two UCI federally qualified health centers History of 20 pack year smoking history ( based on survey self report) 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gelareh Sadigh, MD
Phone
949-745-5066
Email
gsadigh@uci.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Kao
Email
juiyuk@hs.uci.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gelareh Sadigh, MD
Organizational Affiliation
University of California, Irvine
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCI Health - Costa Mesa
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kao
Facility Name
UCI Health Gottschalk Medical Plaza
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kao
Facility Name
UCI Health - Laguna Hills
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kao
Facility Name
UCI Health - Newport Beach MacArthur
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kao
Facility Name
UCI Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kao
Facility Name
UCI Health - Tustin
City
Tustin
State/Province
California
ZIP/Postal Code
92670
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kao
Facility Name
UCI Health-Yorba Linda
City
Yorba Linda
State/Province
California
ZIP/Postal Code
92886
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raymond Kao

12. IPD Sharing Statement

Plan to Share IPD
No

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Empowering Patients' Lung Cancer Screening Uptake

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