Ocean Medical Center
Brick, New Jersey, 08724
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
John F. Kennedy Medical Center
Edison, New Jersey, 08820
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Bayshore Medical Center
Holmdel, New Jersey, 07733
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Southern Ocean Medical Center
Manahawkin, New Jersey, 08050
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Palisades Medical Center
North Bergen, New Jersey, 07047
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Old Bridge Medical Center
Old Bridge, New Jersey, 08857
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Raritan Bay Medical Center
Perth Amboy, New Jersey, 08861
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting
Riverview Medical Center
Red Bank, New Jersey, 07701
Gia Nealy, 201-880-3564, gia.nealy@hmh-cdi.org
Recruiting

Other trials in United States

About this study

Official title: LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities

This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.

Conditions: Lung Cancer
Being tested: LungTalk, Non-tailored lung screening
Keywords: screening, lung cancer, Disparities, social determinants of health, emergency department
Medical subject headings: Lung Neoplasms, Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LungTalkBehavioural
Tailored lung screening intervention
Non-tailored lung screeningOther
Non-tailored lung screening. It involves the addition of education to Social Determinants of Health (SDOH) screening and referral with patient navigation. Patients will be identified, and screened for SDOH needs using the UniteUs SDOH screener that is embedded in the Electronic Health Record (EHR), and connected to geographically-tailored resources (as described above under Arm 1). Participants will then be sent a non-tailored lung screening educational brochure via email to review that details lung cancer risk, lung screening facts, benefits, and potential harms. Within 48 hours, the Community Outreach and Engagement (COE) Patient Navigator will contact the patient to answer questions and provide navigation services as described above in Arm 1.

Study groups in NCT06605534
Study group	Role	What they receive
LungTalk Group	Experimental	LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled Lung Cancer Screening (LCS) knowledge and health beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% CI, 1.03, 3.85, p = 0.03. Receives: Behavioral: LungTalk
Non-tailored Lung Screening Pamphlet Group	Active comparator	Non-tailored Lung Screening Pamphlet is a non-tailored educational brochure, What is Lung Cancer Screening from the GO2 Foundation that will be emailed to the patient. This widely used educational standard of care is a 2-page reader-friendly non-tailored electronic brochure about risk and screening for lung cancer used in clinical and community settings. Receives: Other: Non-tailored lung screening

What is being measured

The primary outcome is the main question the study is designed to answer.

Lung Cancer Screening Uptake
Completion of a Screening Low-Dose Computed Tomography (LDCT) of the Chest confirmed via Electronic Health Records (EHR))
Measured: Assessed at 1 month and 6 months post intervention
Stage of Adoption for Lung Cancer Screening
Screening Intention will be assessed with the Stage of Adoption for Decision- Making About Lung Screening using an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow investigators to assess intent.
Measured: Assessed at 1 week and then at 1 month and 6 months post intervention

Secondary outcomes (9)

Health Literacy Scale
Change in Health Literacy Scale between baseline and 1 week and 1-month post-intervention. The Health Literacy Scale will be measured using the 3-item psychometrically validated Health Literacy Scale by Chew and colleagues. This scale has been supported as valid for detecting inadequate health literacy using Likert scale response options ranging from 0=strongly disagree to 4 =strongly agree with lower scores representative of higher levels of health literacy.
Measured: At one week and one month post intervention
Medical Mistrust Scale
Change in Medical Mistrust Scale between baseline and 1 week and 1-month post-intervention. Medical Mistrust will be measured using the psychometrically validated 5-item Medical Mistrust Scale. This measure assesses constructs related to mistrust of the medical system, including suspicion, discrimination, and lack of support. Likert scale response options range from 1 to 4 with 1=Stongly Disagree to Agree 5=Strongly. Responses are summed (range 5-25), with higher scores indicating more trust. *Negatively worded item is reverse coded. Reliability and validity have been well established with Cronbach's alpha of 0.87-0.88.
Measured: At one week and one month post intervention
Perceived Stigma Scale
Change in Perceived Stigma Scale between baseline and 1 week and 1-month post-intervention. Perceived Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale. The response scale is 1=strongly disagree to 4=strongly agree; range is 5 to 25 (higher stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.
Measured: At one week and one month post intervention
Perceived Risk of Lung Cancer Scale
Change in Perceived Risk of Lung Cancer Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Risk of Lung Cancer on a 3-item scale with Likert-type responses from 1=Strongly Disagree to 4=Strongly Agree. The range of scores is 3 to 12 (higher perceived risk of lung cancer). Cronbach's alpha was 0.88 in our preliminary study.
Measured: At one week and one month post intervention
Perceived Benefits of Lung Cancer Screening Scale
Change in Perceived Benefits of Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Benefits of Lung Cancer Screening on a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits), with a Cronbach's alpha of 0.76 in our preliminary study
Measured: At one week and one month post intervention
Perceived Barriers to Lung Cancer Screening Scale
Change in Perceived Barriers of Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers) with a Cronbach's a of 0.87 in our preliminary psychometric study
Measured: At one week and one month post intervention
Self-Efficacy for Lung Cancer Screening Scale
Change in Self-Efficacy for Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Self-Efficacy for Lung Cancer Screening. This scale has nine items with a four-point Likert response option (1=Not at all Confident and 4 =Very Confident) to assess individual beliefs about ability to arrange and complete an LDCT to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy) with a Cronbach's alpha of 0.92 in our preliminary psychometric study.
Measured: At one week and one month post intervention
Knowledge: Lung Cancer and Screening Scale
Change in Knowledge: Lung Cancer and Lung Screening between baseline and 1 week and 1-month post-intervention. Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. The range of scores is 0 to 7, with 0 being No Knowledge, and 9 being Complete Knowledge.
Measured: At one week and one month post intervention
Lung Cancer Fatalism
Change in Lung Cancer Fatalism between baseline and 1 week and 1-month post-intervention. Lung Cancer Fatalism will be measured with the 11-item dichotomous (0=yes and 1=no) Lung Cancer Fatalism Scale adapted from the Revised Powe Fatalism Inventory that has been psychometrically validated.
Measured: At one week and one month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Oct 202431 Dec 2026

First posted20 Sep 2024
Study start29 Oct 2024
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (37)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06605534
Sponsor's protocol ID: Pro2024-0236
Status last verified: Sep 2026
First submitted: 11 Sep 2024
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
PubMed 33532112
Cancer Facts & Figures for African Americans 2019-2021. In: American Cancer Society. Atlanta: 2019.
United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening.http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatem entFinal/lung-cancer-screening. Updated December 2016. Accessed January 21, 2023.
Rivera MP, Katki HA, Tanner NT, Triplette M, Sakoda LC, Wiener RS, Cardarelli R, Carter-Harris L, Crothers K, Fathi JT, Ford ME, Smith R, Winn RA, Wisnivesky JP, Henderson LM, Aldrich MC. Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement. Am J Respir Crit Care Med. 2020 Oct 1;202(7):e95-e112. doi: 10.1164/rccm.202008-3053ST.
PubMed 33000953
Carter-Harris L, Tan AS, Salloum RG, Young-Wolff KC. Patient-provider discussions about lung cancer screening pre- and post-guidelines: Health Information National Trends Survey (HINTS). Patient Educ Couns. 2016 Nov;99(11):1772-1777. doi: 10.1016/j.pec.2016.05.014. Epub 2016 May 17.
PubMed 27241830
American Lung Association: State of Lung Cancer. In. Chicago, IL: American Lung Association; 2019.
National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
PubMed 21714641
United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening (updated). https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening. Updated March 9, 2021. Accessed February 21, 2024.
Carter-Harris L, Ceppa DP, Hanna N, Rawl SM. Lung cancer screening: what do long-term smokers know and believe? Health Expect. 2017 Feb;20(1):59-68. doi: 10.1111/hex.12433. Epub 2015 Dec 23.
PubMed 26701339
Carter-Harris L, Brandzel S, Wernli KJ, Roth JA, Buist DSM. A qualitative study exploring why individuals opt out of lung cancer screening. Fam Pract. 2017 Apr 1;34(2):239-244. doi: 10.1093/fampra/cmw146.
PubMed 28122849
Carter-Harris L, Slaven JE Jr, Monahan PO, Shedd-Steele R, Hanna N, Rawl SM. Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers. Prev Med Rep. 2018 Feb 3;10:49-54. doi: 10.1016/j.pmedr.2018.01.018. eCollection 2018 Jun.
PubMed 29552458
Carter-Harris L, Slaven JE 2nd, Monahan PO, Draucker CB, Vode E, Rawl SM. Understanding lung cancer screening behaviour using path analysis. J Med Screen. 2020 Jun;27(2):105-112. doi: 10.1177/0969141319876961. Epub 2019 Sep 24.
PubMed 31550991
Draucker CB, Rawl SM, Vode E, Carter-Harris L. Understanding the decision to screen for lung cancer or not: A qualitative analysis. Health Expect. 2019 Dec;22(6):1314-1321. doi: 10.1111/hex.12975. Epub 2019 Sep 27.
PubMed 31560837
De Marchis EH, Brown E, Aceves B, et al. State of the Science of Screening in Healthcare Settings. Social Interventions Research & Evaluation Network, 2022.
Albada A, Ausems MG, Bensing JM, van Dulmen S. Tailored information about cancer risk and screening: a systematic review. Patient Educ Couns. 2009 Nov;77(2):155-71. doi: 10.1016/j.pec.2009.03.005. Epub 2009 Apr 18.
PubMed 19376676

Interested in taking part?

Ana Guadalupe Vielma, PhD

2018803400

ana.vielma@hmh-cdi.org

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities
ClinicalTrials.gov ID: NCT06605534
Acronym / sponsor ID: Pro2024-0236
Conditions: Lung Cancer
Keywords: screening, lung cancer, Disparities, social determinants of health, emergency department
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Hackensack Meridian HealthUniversity, hospital or other
Collaborators: New Jersey Commission on Cancer Research
Study start: 29 Oct 2024 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 20 Sep 2024 (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.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
LungTalk Group	Experimental	Behavioral: LungTalkLungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled Lung Cancer Screening (LCS) knowledge and health beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% CI, 1.03, 3.85, p = 0.03.
Non-tailored Lung Screening Pamphlet Group	Active comparator	Other: Non-tailored lung screeningNon-tailored Lung Screening Pamphlet is a non-tailored educational brochure, What is Lung Cancer Screening from the GO2 Foundation that will be emailed to the patient. This widely used educational standard of care is a 2-page reader-friendly non-tailored electronic brochure about risk and screening for lung cancer used in clinical and community settings.

Who may qualify

Ages: 50 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Aged 50 years to 80 years
Currently smoke cigarettes or quit smoking cigarettes within the past 15 years
20 pack-year smoking history
Has never had lung cancer screening
Able to provide informed consent

Key exclusion criteria (3 listed)

Diagnosed with lung cancer
Has a history of having a lung cancer screening scan
Unable to speak and understand English

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
LungTalkTailored lung screening intervention	Behavioural	LungTalk Group
Non-tailored lung screeningNon-tailored lung screening. It involves the addition of education to Social Determinants of Health (SDOH) screening and referral with patient navigation. Patients will be identified, and screened for SDOH needs using the UniteUs SDOH screener that is embedded in the Electronic Health Record (EHR), and connected to geographically-tailored resources (as described above under Arm 1). Participants will then be sent a non-tailored lung screening educational brochure via email to review that details lung cancer risk, lung screening facts, benefits, and potential harms. Within 48 hours, the Community Outreach and Engagement (COE) Patient Navigator will contact the patient to answer questions and provide navigation services as described above in Arm 1.	Other	Non-tailored Lung Screening Pamphlet Group

Primary outcome

Lung Cancer Screening Uptake
Time frame: Assessed at 1 month and 6 months post intervention
Completion of a Screening Low-Dose Computed Tomography (LDCT) of the Chest confirmed via Electronic Health Records (EHR))
Stage of Adoption for Lung Cancer Screening
Time frame: Assessed at 1 week and then at 1 month and 6 months post intervention
Screening Intention will be assessed with the Stage of Adoption for Decision- Making About Lung Screening using an algorithm of questions used in our prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow investigators to assess intent.

9 secondary outcomes

Health Literacy Scale
Time frame: At one week and one month post intervention
Medical Mistrust Scale
Time frame: At one week and one month post intervention
Perceived Stigma Scale
Time frame: At one week and one month post intervention
Perceived Risk of Lung Cancer Scale
Time frame: At one week and one month post intervention
Perceived Benefits of Lung Cancer Screening Scale
Time frame: At one week and one month post intervention
Perceived Barriers to Lung Cancer Screening Scale
Time frame: At one week and one month post intervention
Self-Efficacy for Lung Cancer Screening Scale
Time frame: At one week and one month post intervention
Knowledge: Lung Cancer and Screening Scale
Time frame: At one week and one month post intervention
Lung Cancer Fatalism
Time frame: At one week and one month post intervention

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 8 Sep 2026.
Background: PubMed 33532112Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.
BackgroundCancer Facts & Figures for African Americans 2019-2021. In: American Cancer Society. Atlanta: 2019.
BackgroundUnited States Preventive Services Task Force. Final recommendation statement: Lung cancer screening.http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatem entFinal/lung-cancer-screening. Updated December 2016. Accessed January 21, 2023.
Background: PubMed 33000953Rivera MP, Katki HA, Tanner NT, Triplette M, Sakoda LC, Wiener RS, Cardarelli R, Carter-Harris L, Crothers K, Fathi JT, Ford ME, Smith R, Winn RA, Wisnivesky JP, Henderson LM, Aldrich MC. Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement. Am J Respir Crit Care Med. 2020 Oct 1;202(7):e95-e112. doi: 10.1164/rccm.202008-3053ST.
Background: PubMed 27241830Carter-Harris L, Tan AS, Salloum RG, Young-Wolff KC. Patient-provider discussions about lung cancer screening pre- and post-guidelines: Health Information National Trends Survey (HINTS). Patient Educ Couns. 2016 Nov;99(11):1772-1777. doi: 10.1016/j.pec.2016.05.014. Epub 2016 May 17.
BackgroundAmerican Lung Association: State of Lung Cancer. In. Chicago, IL: American Lung Association; 2019.
Background: PubMed 21714641National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
BackgroundUnited States Preventive Services Task Force. Final recommendation statement: Lung cancer screening (updated). https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening. Updated March 9, 2021. Accessed February 21, 2024.
Background: PubMed 26701339Carter-Harris L, Ceppa DP, Hanna N, Rawl SM. Lung cancer screening: what do long-term smokers know and believe? Health Expect. 2017 Feb;20(1):59-68. doi: 10.1111/hex.12433. Epub 2015 Dec 23.
Background: PubMed 28122849Carter-Harris L, Brandzel S, Wernli KJ, Roth JA, Buist DSM. A qualitative study exploring why individuals opt out of lung cancer screening. Fam Pract. 2017 Apr 1;34(2):239-244. doi: 10.1093/fampra/cmw146.
Background: PubMed 29552458Carter-Harris L, Slaven JE Jr, Monahan PO, Shedd-Steele R, Hanna N, Rawl SM. Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers. Prev Med Rep. 2018 Feb 3;10:49-54. doi: 10.1016/j.pmedr.2018.01.018. eCollection 2018 Jun.
Background: PubMed 31550991Carter-Harris L, Slaven JE 2nd, Monahan PO, Draucker CB, Vode E, Rawl SM. Understanding lung cancer screening behaviour using path analysis. J Med Screen. 2020 Jun;27(2):105-112. doi: 10.1177/0969141319876961. Epub 2019 Sep 24.
Individual participant dataSharing planned: No

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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.

Ana Guadalupe Vielma, PhD contact

2018803400

ana.vielma@hmh-cdi.org

Francis Valenzona contact

2018803400

francis.valenzona@hmh-cdi.org

Lisa Carter-Bawa, PhD principal investigator

Hackensack Meridian Health

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LungTalk and Non-tailored lung screening in people with Lung Cancer, run by Hackensack Meridian Health at 10 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 6 inclusion and 3 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 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 Ana Guadalupe Vielma, PhD (2018803400, ana.vielma@hmh-cdi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lung Cancer Screening Uptake (time frame: Assessed at 1 month and 6 months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06605534, which also lists 37 linked publications.

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 8 Sep 2026.