Clinical trial NCT05679349: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Carcinoma
Tobacco-Related Carcinoma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-01-11
Enrollment: 822
Sex: ALL
Minimum age (years): 50
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief 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.

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: 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.

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

Primary outcomes:
measure: Completion of initial lung cancer screening (LCS)
timeFrame: Within 4 months of randomization
Secondary outcomes:
measure: Referral for LCS
timeFrame: Up to 5 years
measure: Tobacco cessation services
timeFrame: Up to 5 years
measure: Repeat annual lung cancer screenings within 11-16 months of original screening
timeFrame: within 11-16 months of original screening
measure: Diagnostic follow up after initial lung cancer screening
timeFrame: Up to 4 months of screening
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: