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Trial Title:
Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking
NCT ID:
NCT05679349
Condition:
Lung Carcinoma
Tobacco-Related Carcinoma
Conditions: Official terms:
Carcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Screening
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete survey
Arm group label:
Group A (Providers): (survey, online educational activity)
Intervention type:
Other
Intervention name:
Educational Activity
Description:
Undergo online shared decision making training and distance learning
Arm group label:
Group A (Providers): (survey, online educational activity)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete survey
Arm group label:
Group B (Providers): (survey)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Undergo electronic health record review
Arm group label:
Group A (Patients): (EHR, educational activity, counseling))
Intervention type:
Other
Intervention name:
Educational Activity
Description:
Undergo online shared decision making training and distance learning
Arm group label:
Group A (Patients): (EHR, educational activity, counseling))
Intervention type:
Other
Intervention name:
Counseling
Description:
Undergo shared decision making counseling
Arm group label:
Group A (Patients): (EHR, educational activity, counseling))
Other name:
Counseling Intervention
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete survey
Arm group label:
Group B (Patients): (survey)
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Undergo electronic health record review
Arm group label:
Group B (Patients): (survey)
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.
Criteria for 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
Gender:
All
Minimum age:
50 Years
Maximum age:
77 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ronald Myers
Start date:
April 1, 2024
Completion date:
April 30, 2027
Lead sponsor:
Agency:
Ronald Myers
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679349
