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Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking

NCT05679349 · Thomas Jefferson University
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Official title
Provider Support and Patient Outreach in Lung Cancer Screening
About this study
PRIMARY OBJECTIVES: I. Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM). SECONDARY OBJECTIVES: I. Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators. EXPLORATORY OBJECTIVES: I. Assess intervention impact on: Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result. OUTLINE: In accordance with the 2X2 cluster randomized design, primary care practices along with providers initially are randomized to 1 of 2 groups. Then, patients within the practices are randomized to 1 of 2 groups. PROVIDERS: GROUP A: PROVIDER SUPPORT GROUP: Providers complete baseline and endpoint surveys once on study. Providers also undergo online educational activity on study. Participants undergo distance learning on study. GROUP B: PROVIDER CONTROL GROUP: Participants complete baseline and endpoint surveys once on study. PATIENTS: GROUP A: PROVIDER SUPPORT + PATIENT OUTREACH GROUP: Providers receive support once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys. GROUP B: PROVIDER SUPPORT + PATIENT CONTROL GROUP: Providers receive support once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys. GROUP C: PROVIDER CONTROL + PATIENT OUTREACH GROUP: Providers receive usual care once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys. Group D: PROVIDER CONTROL + PATIENT CONTROL GROUP: Providers receive usual care once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.
Eligibility criteria
Inclusion Criteria: * 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 * 50 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) Exclusion Criteria: * 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 * 71250 - CT w/o contrast * 71260 - CT w/ contrast * 71270 - CT with and w/o contrast * 71275 - CT angiography chest * 78815 - Positron emission tomography computed tomography (PET CT) skull base to mid-thigh * 78816 - 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
Study design
Enrollment target: 822 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-04-01
Estimated completion: 2027-02-26
Last updated: 2026-05-29
Interventions
Other: Survey AdministrationOther: Educational ActivityOther: Survey AdministrationOther: Electronic Health Record ReviewOther: Educational ActivityOther: CounselingOther: Survey AdministrationOther: Electronic Health Record Review
Primary outcomes
  • Completion of initial lung cancer screening (LCS) (Within 4 months of randomization)
Sponsor
Ronald Myers · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactRonald Myers, PhD · contact · ronald.myers@jefferson.edu · 215-503-4085
All locations (1)
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting
Philadelphia, Pennsylvania, United States
Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking · TrialPath