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

Primary Purpose

Lung Carcinoma, Tobacco-Related Carcinoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survey Administration
Educational Activity
Survey Administration
Electronic Health Record Review
Educational Activity
Counseling
Survey Administration
Electronic Health Record Review
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Carcinoma

Eligibility Criteria

50 Years - 77 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

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

Group B (Providers): (survey)

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

Group B (Patients): (survey)

Arm Description

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

Participants complete survey at baseline and end of study survey.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Referral for LCS
Referrals for lung cancer screenings will be found by reviewing electronic medical records.
Tobacco cessation services
Referrals for tobacco treatment services will be found by reviewing medical records.
Repeat annual lung cancer screenings within 11-16 months of original screening
Number of repeat screenings will be found by reviewing electronic medical records.
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.

Full Information

First Posted
December 23, 2022
Last Updated
May 10, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT05679349
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Carcinoma, Tobacco-Related Carcinoma

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
822 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Providers): (survey, online educational activity)
Arm Type
Experimental
Arm Description
Participants complete survey on study. Participants undergo online educational activity on study. Participants undergo distance learning on study.
Arm Title
Group B (Providers): (survey)
Arm Type
Active Comparator
Arm Description
Participants complete survey at baseline and end of study survey.
Arm Title
Group A (Patients): (EHR, educational activity, counseling))
Arm Type
Experimental
Arm Description
Patients undergo EHR review on study. Patients undergo educational activity on study. Patients also undergo SDM counseling once on study.
Arm Title
Group B (Patients): (survey)
Arm Type
Active Comparator
Arm Description
Patients undergo EHR review on study and complete telephone survey throughout the trial.
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete survey
Intervention Type
Other
Intervention Name(s)
Educational Activity
Intervention Description
Undergo online shared decision making training and distance learning
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete survey
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Undergo electronic health record review
Intervention Type
Other
Intervention Name(s)
Educational Activity
Intervention Description
Undergo online shared decision making training and distance learning
Intervention Type
Other
Intervention Name(s)
Counseling
Other Intervention Name(s)
Counseling Intervention
Intervention Description
Undergo shared decision making counseling
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete survey
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Undergo electronic health record review
Primary Outcome Measure Information:
Title
Completion of initial lung cancer screening (LCS)
Description
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.
Time Frame
Within 4 months of randomization
Secondary Outcome Measure Information:
Title
Referral for LCS
Description
Referrals for lung cancer screenings will be found by reviewing electronic medical records.
Time Frame
Up to 5 years
Title
Tobacco cessation services
Description
Referrals for tobacco treatment services will be found by reviewing medical records.
Time Frame
Up to 5 years
Title
Repeat annual lung cancer screenings within 11-16 months of original screening
Description
Number of repeat screenings will be found by reviewing electronic medical records.
Time Frame
within 11-16 months of original screening
Title
Diagnostic follow up after initial lung cancer screening
Description
Number of patients that had follow up within 4 months of initial lung cancer screening will be found by reviewing electronic medical records.
Time Frame
Up to 4 months of screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald Myers, PhD
Phone
215-503-4085
Email
ronald.myers@jefferson.edu
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Myers

12. IPD Sharing Statement

Learn more about this trial

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

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