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

Lung Carcinoma Clinical Trial

Official title:

Provider Support and Patient Outreach in Lung Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679349
• Other study ID #: 22F.808
• Secondary ID: R01CA258849
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: May 2024
• Source: Thomas Jefferson University
• Contact: Ronald Myers, PhD
• Phone: 215-503-4085
• Email: ronald.myers[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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: Providers are randomized to 1 of 2 groups. Patients are randomized to 1 of 2 groups.

PROVIDERS:

GROUP A: PROVIDER SUPPORT GROUP: Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.

GROUP B: PROVIDER CONTROL GROUP: Participants complete survey at baseline and end of study survey.

PATIENTS:

GROUP A: Patients undergo electronic health records (EHR) review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.

GROUP B: Patients undergo EHR review on study and complete telephone survey throughout the trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 822
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Lung Carcinoma
• Tobacco-Related Carcinoma

Intervention

Other:
• Survey Administration
Complete survey
• Educational Activity
Undergo online shared decision making training and distance learning
• Survey Administration
Complete survey
• Electronic Health Record Review
Undergo electronic health record review
• Educational Activity
Undergo online shared decision making training and distance learning
• Counseling
Undergo shared decision making counseling
• Survey Administration
Complete survey
• Electronic Health Record Review
Undergo electronic health record review

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Ronald Myers	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Referral for LCS	Referrals for lung cancer screenings will be found by reviewing electronic medical records.	Up to 5 years
Secondary	Tobacco cessation services	Referrals for tobacco treatment services will be found by reviewing medical records.	Up to 5 years
Secondary	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
Secondary	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