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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Carcinoma; Tobacco-Related Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Electronic Health Record Review; Other: Educational Activity; Other: Counseling

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 822
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ronald Myers, PhD; Phone Number: 215-503-4085; Email: ronald.myers@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Recruiting
      • Sidney Kimmel Cancer Center at Thomas Jefferson University
      • Contact: Ronald Myers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Providers): (survey, online educational activity); Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.	Other: Survey Administration; Complete survey; Other: Educational Activity; Undergo online shared decision making training and distance learning
Active Comparator: Group B (Providers): (survey); Participants complete survey at baseline and end of study survey.	Other: Survey Administration; Complete survey
Experimental: Group A (Patients): (EHR, educational activity, counseling)); Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.	Other: Electronic Health Record Review; Undergo electronic health record review; Other: Educational Activity; Undergo online shared decision making training and distance learning; Other: Counseling; Undergo shared decision making counseling; Other Names: Counseling Intervention
Active Comparator: Group B (Patients): (survey); Patients undergo EHR review on study and complete telephone survey throughout the trial.	Other: Survey Administration; Complete survey; Other: Electronic Health Record Review; Undergo electronic health record review

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral for LCS	Referrals for lung cancer screenings will be found by reviewing electronic medical records.	Up to 5 years
Tobacco cessation services	Referrals for tobacco treatment services will be found by reviewing medical records.	Up to 5 years
Repeat annual lung cancer screenings within 11-16 months of original screening	Number of repeat screenings will be found by reviewing electronic medical records.	within 11-16 months of original screening
Diagnostic follow up after initial lung cancer screening	Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records.	Up to 4 months of screening

Collaborators and Investigators

• Sponsor: Ronald Myers
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 26, 2027

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Behavioral Disciplines and Activities; Mental Health Services; Counseling
• Other Study ID Numbers: 22F.808; R01CA258849 (U.S. NIH Grant/Contract); JT 24704 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No