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Recruiting

NCT Number: NCT05679349

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

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.

Recruiting

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Key information

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Ronald Myers

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Complete survey

Educational Activity

Other

Undergo online shared decision making training and distance learning

Electronic Health Record Review

Other

Undergo electronic health record review

Counseling

Other

Undergo shared decision making counseling

Other names: Counseling Intervention

Primary outcomes

  1. Completion of initial lung cancer screening (LCS)

    Time frame: Within 4 months of randomization

    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.

Secondary outcomes

  1. Referral for LCS

    Time frame: Up to 5 years

    Referrals for lung cancer screenings will be found by reviewing electronic medical records.

  2. Tobacco cessation services

    Time frame: Up to 5 years

    Referrals for tobacco treatment services will be found by reviewing medical records.

  3. Repeat annual lung cancer screenings within 11-16 months of original screening

    Time frame: within 11-16 months of original screening

    Number of repeat screenings will be found by reviewing electronic medical records.

  4. Diagnostic follow up after initial lung cancer screening

    Time frame: Up to 4 months of screening

    Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records.

Study contacts

Contact information is provided by the study sponsor or research team.

Ronald Myers, PhD

CONTACT

[email protected]

215-503-4085

Sponsors and collaborators

Lead sponsor

Ronald Myers

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Provider Support and Patient Outreach in Lung Cancer Screening

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 11, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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