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

Ronald Myers

Status: Enrolling

Conditions: Tobacco-Related Carcinoma; Lung Carcinoma

Treatments: Other: Counseling; Other: Educational Activity; Other: Survey Administration; Other: Electronic Health Record Review

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05679349

JT 24704 (Other Identifier)

22F.808

R01CA258849 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 822 estimated patients

Sex: All

Ages: 50 to 77 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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822 participants in 4 patient groups

Group A (Providers): (survey, online educational activity)

Experimental group

Description:

Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.

Treatment:

Other: Survey Administration

Other: Educational Activity

Other: Educational Activity

Other: Survey Administration

Other: Survey Administration

Group B (Providers): (survey)

Active Comparator group

Description:

Participants complete survey at baseline and end of study survey.

Treatment:

Other: Survey Administration

Other: Survey Administration

Other: Survey Administration

Group A (Patients): (EHR, educational activity, counseling))

Experimental group

Description:

Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.

Treatment:

Other: Electronic Health Record Review

Other: Educational Activity

Other: Educational Activity

Other: Counseling

Other: Electronic Health Record Review

Group B (Patients): (survey)

Active Comparator group

Description:

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

Treatment:

Other: Electronic Health Record Review

Other: Survey Administration

Other: Survey Administration

Other: Electronic Health Record Review

Other: Survey Administration