Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking
Provider Support and Patient Outreach in Lung Cancer Screening
3 other identifiers
interventional
822
1 country
1
Brief Summary
This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Education and counseling may be an effective method to help providers and patients learn about lung cancer screening. Providing education and decision counseling to providers and patients may increase lung cancer screening.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2022
CompletedFirst Posted
Study publicly available on registry
January 11, 2023
CompletedStudy Start
First participant enrolled
April 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
May 6, 2026
May 1, 2026
2.8 years
December 23, 2022
May 1, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Completion of initial lung cancer screening (LCS)
LCS will be assessed through an endpoint electronic medical records (EMR) search, supplemented with a question on the participant endpoint survey to capture any LCS performed outside the health system and/or not captured in the EMR.
Within 4 months of randomization
Secondary Outcomes (4)
Referral for LCS
Up to 5 years
Tobacco cessation services
Up to 5 years
Repeat annual lung cancer screenings within 11-16 months of original screening
within 11-16 months of original screening
Diagnostic follow up after initial lung cancer screening
Up to 4 months of screening
Study Arms (4)
Group A (Providers): (survey, online educational activity)
EXPERIMENTALParticipants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.
Group B (Providers): (survey)
ACTIVE COMPARATORParticipants complete survey at baseline and end of study survey.
Group A (Patients): (EHR, educational activity, counseling))
EXPERIMENTALPatients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.
Group B (Patients): (survey)
ACTIVE COMPARATORPatients undergo EHR review on study and complete telephone survey throughout the trial.
Interventions
Undergo online shared decision making training and distance learning
Undergo shared decision making counseling
Undergo electronic health record review
Eligibility Criteria
You may qualify if:
- PRACTICE LEVEL:
- Primary care practice (family medicine, geriatrics, internal medicine) in one of the 4 participating health systems
- Practice using the main electronic medical record (EMR) of each system, in order to run appropriate patient recruitment reports
- Practice with at least 50% of practice providers (physicians and advanced care providers) consenting to participate
- PATIENT LEVEL:
- Have an office or telemedicine established patient visit scheduled with a primary care provider in one of the participating practices within next 14 to 25 days
- to 77 years of age
- Have at least a 20-pack-year smoking history (based on self-report at baseline eligibility assessment)
- Currently smoke or have quit smoking within the past 15 years (based on self-report at baseline eligibility assessment)
- Able to communicate in English or Spanish (determined at baseline eligibility assessment)
You may not qualify if:
- PATIENT OUTREACH:
- Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows
- G0297 - LDCT screening
- CT w/o contrast
- CT w/ contrast
- CT with and w/o contrast
- CT angiography chest
- Positron emission tomography computed tomography (PET CT) skull base to mid-thigh
- PET CT whole body
- Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
- Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
- Dementia (diagnosis codes F03.90 or F03.91) in EHR
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ronald Myerslead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor - Medical Oncology
Study Record Dates
First Submitted
December 23, 2022
First Posted
January 11, 2023
Study Start
April 1, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
May 6, 2026
Record last verified: 2026-05