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

Official title

Provider Support and Patient Outreach in Lung Cancer Screening

Overview

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.

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.

Interventions

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

Primary outcome measures

• Completion of initial lung cancer screening (LCS) [Time frame: Within 4 months of randomization]

Secondary outcome measures (4)

• Referral for LCS [Time frame: Up to 5 years]
• Tobacco cessation services [Time frame: Up to 5 years]
• Repeat annual lung cancer screenings within 11-16 months of original screening [Time frame: within 11-16 months of original screening]
• Diagnostic follow up after initial lung cancer screening [Time frame: Up to 4 months of screening]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Factorial

Masking

Quadruple blind

Primary purpose

Screening

Study locations

United States · 1 center

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT05679349 · 22F.808 · R01CA258849 · JT 24704

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗