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

NCT ID: NCT05679349

Last Updated: 2025-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Lung Carcinoma Tobacco-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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

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

Group Type EXPERIMENTAL

Survey Administration

Intervention Type OTHER

Complete survey

Educational Activity

Intervention Type OTHER

Undergo online shared decision making training and distance learning

Group B (Providers): (survey)

Participants complete survey at baseline and end of study survey.

Group Type ACTIVE_COMPARATOR

Survey Administration

Intervention Type OTHER

Complete survey

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

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

Group Type EXPERIMENTAL

Electronic Health Record Review

Intervention Type OTHER

Undergo electronic health record review

Educational Activity

Intervention Type OTHER

Undergo online shared decision making training and distance learning

Counseling

Intervention Type OTHER

Undergo shared decision making counseling

Group B (Patients): (survey)

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

Group Type ACTIVE_COMPARATOR

Survey Administration

Intervention Type OTHER

Complete survey

Electronic Health Record Review

Intervention Type OTHER

Undergo electronic health record review

Interventions

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Survey Administration

Complete survey

Intervention Type OTHER

Educational Activity

Undergo online shared decision making training and distance learning

Intervention Type OTHER

Survey Administration

Complete survey

Intervention Type OTHER

Electronic Health Record Review

Undergo electronic health record review

Intervention Type OTHER

Educational Activity

Undergo online shared decision making training and distance learning

Intervention Type OTHER

Counseling

Undergo shared decision making counseling

Intervention Type OTHER

Survey Administration

Complete survey

Intervention Type OTHER

Electronic Health Record Review

Undergo electronic health record review

Intervention Type OTHER

Other Intervention Names

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Counseling Intervention

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Ronald Myers

OTHER

Sponsor Role lead

Responsible Party

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Ronald Myers

Professor - Medical Oncology

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ronald Myers, PhD

Role: CONTACT

215-503-4085

Facility Contacts

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Ronald Myers

Role: primary

Other Identifiers

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R01CA258849

Identifier Type: NIH

Identifier Source: secondary_id

View Link

JT 24704

Identifier Type: OTHER

Identifier Source: secondary_id

22F.808

Identifier Type: -

Identifier Source: org_study_id

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