Back to resultsA Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening
Primary Purpose
Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Provider Prompt & Patient Outreach and Education
Sponsored by
About this trial
This is an interventional screening trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 55-80 years old;
- current cigarette smoker or quit within 15 years;
- a 30+ pack-year smoking history;
- non-adherent to lung screening (>13 months);
- English-speaking;
- scheduled for an upcoming clinic appointment (2 weeks - 8 weeks); and
- able and willing to provide meaningful consent and complete telephone interviews
Exclusion Criteria:
- Individuals with a history of lung cancer
Sites / Locations
- MedStar Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Multilevel Intervention
Nonequivalent Control Group
Arm Description
Outcomes
Primary Outcome Measures
provider-patient discussion
Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')
lung cancer screening intentions
Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')
lung cancer screening knowledge
Lung cancer screening knowledge measure
Secondary Outcome Measures
lung cancer screening referrals
Total number of lung screening orders captured via the electronic medical record
lung cancer screening completion rates
Total number of lung screening completions captured via the electronic medical record
Full Information
NCT ID
NCT04675476
First Posted
December 4, 2020
Last Updated
September 22, 2023
Sponsor
Georgetown University
1. Study Identification
Unique Protocol Identification Number
NCT04675476
Brief Title
A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening
Official Title
A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
February 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
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
To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.
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
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
368 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multilevel Intervention
Arm Type
Experimental
Arm Title
Nonequivalent Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Provider Prompt & Patient Outreach and Education
Intervention Description
To target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit.
Primary Outcome Measure Information:
Title
provider-patient discussion
Description
Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')
Time Frame
1-week post-visit
Title
lung cancer screening intentions
Description
Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')
Time Frame
1-week post-visit
Title
lung cancer screening knowledge
Description
Lung cancer screening knowledge measure
Time Frame
1-week post-visit
Secondary Outcome Measure Information:
Title
lung cancer screening referrals
Description
Total number of lung screening orders captured via the electronic medical record
Time Frame
6-months
Title
lung cancer screening completion rates
Description
Total number of lung screening completions captured via the electronic medical record
Time Frame
6-months
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:
50-80 years old;
current cigarette smoker or quit within 15 years;
a 20+ pack-year smoking history;
non-adherent to lung screening (>13 months);
English-speaking;
scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and
able and willing to provide meaningful consent and complete telephone interviews
Exclusion Criteria:
Individuals with a history of lung cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Randi M Williams, PhD
Phone
(202) 687-7036
Email
rmw27@georgetown.edu
Facility Information:
Facility Name
MedStar Health
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening
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