Health Education Approach to Lung Screening

NCT ID: NCT06070870

Last Updated: 2025-02-25

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

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2026-04-30

Brief Summary

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Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)

Detailed Description

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This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patient Navigation

Centralized patient navigators will be trained to help patients navigate the clinical, logistical, and financial aspects of LCS. Navigators employ case management approaches based on social work principles. The experience of patient navigation will be tailored to the individual participant

Group Type EXPERIMENTAL

Patient Navigation

Intervention Type BEHAVIORAL

Navigation will address the following 4 domains of barriers to screening:

* Individual
* Organizational
* Economic
* Sociocultural At the first visit, navigators will assess the participant's barriers in each of these domains. Any follow-up visits, if necessary, will be used to help the participant overcome these barriers to screening

Interventions

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Patient Navigation

Navigation will address the following 4 domains of barriers to screening:

* Individual
* Organizational
* Economic
* Sociocultural At the first visit, navigators will assess the participant's barriers in each of these domains. Any follow-up visits, if necessary, will be used to help the participant overcome these barriers to screening

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Meets current USPSTF guidelines for lung cancer screening (LCS)
* 20 pack-year smoking history Note: A pack-year is a way of calculating how much a person has smoked in their lifetime.

One pack-year is the equivalent of smoking an average of 20 cigarettes-1 pack-per day for a year.

* Currently smokes or has quit smoking within the past 15 years
* Identifies as Black or African-American Note: Both Hispanic/Latino and Non-Hispanic/Latino patients are eligible as long as they also identify as Black or African-American (eg, Afro-Latino).
* Willing to complete all navigation-related study activities
* Able to understand and the willingness to sign a written informed consent document

Exclusion Criteria

* Known history of cancer (except squamous cell skin cancer), or coughing up blood in the past 5 years, as reported by the individual
* Has undergone a previous lung cancer screening
* Inability to speak English
* Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stand Up To Cancer

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vanessa Sheppard, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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University of North Carolina-Chapel Hill

Carrboro, North Carolina, United States

Site Status NOT_YET_RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status NOT_YET_RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Massey IIT Research Operations

Role: CONTACT

804-628-6430

Facility Contacts

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Christopher Lyu, MPA

Role: primary

919-966-2865

Alison Brenner, MD

Role: backup

(919) 966-2865

Ellen Gomez, MA

Role: primary

843-876-2428

Marvella Ford, MD

Role: backup

843-876-2428

Massey CPC Team

Role: primary

804-628-6430

Other Identifiers

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HM20026222

Identifier Type: OTHER

Identifier Source: secondary_id

SU2C-WINN

Identifier Type: -

Identifier Source: org_study_id

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