Lung CancerHEALSNCT06070870
Health Education Approach to Lung Screening
A study testing Patient Navigation in people with Lung Cancer, run by Virginia Commonwealth University at 3 sites in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Patient Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Oct 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A patient who meets any of the following exclusion criteria is ineligible to participate in the study:
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of North Carolina-Chapel Hill
Carrboro, North Carolina, 27510
Christopher Lyu, MPA, (919) 966-2865, Christopher_Lyu@med.unc.edu
Alison Brenner, MD, (919) 966-2865
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Megan Ellison, Ed.D, 843-876-2428, ellisome@musc.edu
Marvella Ford, MD, 843-876-2428
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23298
Massey CPC Team, 804-628-6430, MasseyCPC@vcu.edu
Sun Jung Kim, PhD
About this study
Official title: Health Education Approach to Lung Screening (HEALS)
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)
Read the detailed description
This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).
- Conditions
- Lung Cancer
- Being tested
- Patient Navigation
- Keywords
- Lung cancer, Screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient NavigationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation | Experimental | 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 Receives: Behavioral: Patient Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of study patients who complete lung cancer screening (LCS) through the patient navigation process
Evaluate the impact of the patient navigation program on the number of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT).
Measured: 2 weeks to 10 months following day 1, varies by participant
Secondary outcomes (6)
Assess the feasibility and acceptability of the patient navigation program
Determine the number of participants that are satisfied with the navigation program by utilizing Was It Worth It instrument; that consists of 8 items that are are answered "yes", "no" or "uncertain".
Measured: Day 1
Assess the feasibility and acceptability of the patient navigation program
Determine the number of participants that are satisfied with the navigation program by utilizing Was It Worth It instrument; that consists of 8 items that are are answered "yes", "no" or "uncertain" after the navigation program.
Measured: 2 weeks to 10 months following day 1, varies by participant
Assess the impact of the patient navigation program on patient health-related quality of life at baseline.
Utilizing Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items) scores before and after navigation intervention. Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items), measures assess physical, mental, and social health where 5=Never, 4=Rarely, 3=Sometimes, 2=Often, and 1=Always. Higher scores indicate better health.
Measured: Day 1
Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.
Utilizing Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items) scores before and after navigation intervention. Patient-Reported Outcome Measurement Information System (PROMIS) v1.2 Global Health Scale (10 items), measures assess physical, mental, and social health, where 5=Never, 4=Rarely, 3=Sometimes, 2=Often, and 1=Always. Higher scores indicate better health.
Measured: 2 weeks to 10 months following day 1, varies by participant
Assess the impact of the patient navigation program on patient financial distress
Determine the number of participants that have financial distress at baseline utilizing Financial Distress measure scores at baseline. Study-specific financial distress measure (8 items) each item will need to be individually coded 1-5, with 1=completely disagree to 5=completely agree and 98 for Don't know and 99 for Not applicable.
Measured: Day 1
Assess the impact of the patient navigation program on patient financial distress
Determine the number of participants that have lessening financial distress after the navigation program utilizing Financial Distress measure scores at baseline. Study-specific financial distress measure (8 items) each item will be individually coded 1-5, with 1=completely disagree to 5=completely agree and 98 for Don't know and 99 for Not applicable.
Measured: 2 weeks to 10 months following day 1, varies by participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start10 Oct 2023
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Stand Up To Cancer
- Responsible party
- Sponsor
- Investigators
- Sun Jung Kim, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070870
- Sponsor's protocol ID
- SU2C-WINN
- Other IDs
- HM20026222
- Acronym
- HEALS
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently there is not a plan to share with other researchers not working on the protocol.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Education Approach to Lung Screening (HEALS)
- ClinicalTrials.gov ID
- NCT06070870
- Acronym / sponsor ID
- HEALS / SU2C-WINN
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Screening
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Stand Up To Cancer
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
This is a single-arm study of a patient navigation intervention to increase access to lung cancer screening (LCS).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation | Experimental | Behavioral: Patient NavigationCentralized 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 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (5 listed)
- A patient who meets any of the following exclusion criteria is ineligible to participate in the study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient NavigationNavigation 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 | Behavioural | Patient Navigation |
Primary outcome
Number of study patients who complete lung cancer screening (LCS) through the patient navigation process
Time frame: 2 weeks to 10 months following day 1, varies by participant
Evaluate the impact of the patient navigation program on the number of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT).
6 secondary outcomes
Assess the feasibility and acceptability of the patient navigation program
Time frame: Day 1
Assess the feasibility and acceptability of the patient navigation program
Time frame: 2 weeks to 10 months following day 1, varies by participant
Assess the impact of the patient navigation program on patient health-related quality of life at baseline.
Time frame: Day 1
Assess the impact of the patient navigation program on patient health-related quality of life after navigation intervention.
Time frame: 2 weeks to 10 months following day 1, varies by participant
Assess the impact of the patient navigation program on patient financial distress
Time frame: Day 1
Assess the impact of the patient navigation program on patient financial distress
Time frame: 2 weeks to 10 months following day 1, varies by participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No. Currently there is not a plan to share with other researchers not working on the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sun Jung Kim, PhD principal investigator
Virginia Commonwealth University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Navigation in people with Lung Cancer, run by Virginia Commonwealth University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Massey IIT Research Operations (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of study patients who complete lung cancer screening (LCS) through the patient navigation process (time frame: 2 weeks to 10 months following day 1, varies by participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.