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Lung CancerNCT07792824

Witness Project Lung

A study testing Witness Project Lung and General Educational Program in people with Lung Cancer, run by Hackensack Meridian Health at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The long-term objective is to improve lung cancer screening uptake among screening-eligible Black adults and thereby reduce the population burden of late-stage diagnosis and mortality. 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?
Witness Project Lung and General Educational Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
1 siteUnited States
Study dates
15 Jan 2027to 1 Aug 2032
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

  • Aged 50 years to 80 years
  • Currently smoke cigarettes or quit smoking cigarettes within the past 15 years
  • 20 pack-year smoking history
  • Able to speak and understand English
  • Self-identify as a Black or African American individual

Who cannot join

  • Diagnosed with lung cancer
  • Unable to speak and understand English
  • Individuals who do not read English will be able to participate in the study. If an individual indicates they cannot read English, the Study Information Sheet will be read to them allowing ample time for questions prior to their decision to enroll in the study or not.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ana G Vielma, PhD contact

9566398726

Ana.vielma@hmh-cdi.org

United States1 site
  • Hackensack Meridian Health - Center for Discovery and Innovation

    Nutley, New Jersey, 07110

    Maureen Ghosh, 201-880-3400, maureen.ghosh@hmh-cdi.org

Other trials in United States

About this study

Official title: CLEAR-LUNG (Community-Level Effectiveness to Advance Reach in Lung Cancer Screening)

The long-term objective is to improve lung cancer screening uptake among screening-eligible Black adults and thereby reduce the population burden of late-stage diagnosis and mortality. The short-term objective of this study is to rigorously test the effectiveness, mechanisms, and implementation readiness of Witness Project® Lung.

Read the detailed description

This study will conduct a type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness of a community-based culturally crafted educational intervention (Witness Project® Lung) compared to a community-based general cancer screening educational program (as the control) for increasing adoption of lung screening within the Black American community while gathering information on its delivery and potential for implementation in a real-world setting. The target population is Black American lung screening eligible individuals. This study will use both quantitative and qualitative methods for data collection and analysis to address the study aims.

Conditions
Lung Cancer
Being tested
Witness Project Lung, General Educational Program
Keywords
lung cancer screening, community setting, tailored intervention
Medical subject headings
Lung Neoplasms

What participants receive

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

  • Witness Project LungBehavioural

    The Witness Lung Lung program is led by the Witness Role Model (WRM) using visual (i.e., geographically specific slide presentation with New Jersey (NJ) or New York (NY) lung screening resources), audio and video (i.e., short testimonials), and text (i.e., geographically-tailored take-home hand-out) components. At the end of the program, participants will be asked if they would like the Community Health Worker (CHW) to follow-up with them via their preferred method of contact to navigate them to screening. The CHW will also be available to meet with participants after the program to answer additional questions. Witness Project® Lung is a 60-minute program.

  • General Educational ProgramBehavioural

    The educational program consists of a didactic presentation about all screen-detectable cancers (breast, cervical, colorectal, lung, prostate) and their screening test(s) including eligibility criteria, guidelines, and how to get screened followed by a question-and-answer session. At the end, participants will be asked if they would like the CHW to follow-up with them to navigate them to screening options. The CHW will also be available to meet with participants after the program

Study groups in NCT07792824
Study groupRoleWhat they receive
Witness Project LungExperimentalThis is a 60 minute comprehensive educational program about lung cancer and screening that leverages the cancer and cancer screening experience of Black Americans through testimonials and 'witnessing' to community members in faith- or community-based settings. Each Witness Project® Lung program is conducted by a Witness Role Model and supported by a Community Health Worker from the community-based health system.
Receives: Behavioral: Witness Project Lung
General Educational ProgramActive comparatorA 60-minute general educational program about cancer screening will be conducted by the CHW. The educational program consists of a didactic presentation about all screen-detectable cancers (breast, cervical, colorectal, lung, prostate) and their screening test(s) including eligibility criteria, guidelines, and how to get screened followed by a question-and-answer session.
Receives: Behavioral: General Educational Program

What is being measured

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

  1. Effectiveness of Witness Project Lung: Screening Uptake

    Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan).

    Measured: At baseline

  2. Effectiveness of Witness Project Lung: Screening Uptake

    Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan).

    Measured: At six-months post-intervention

Secondary outcomes (19)
  1. Stage of Adoption for Decision-Making About Lung Screening

    Stage of Adoption for Decision-Making About Lung Screening will be assessed with an algorithm of questions used in the investigator's prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow us to assess intent if someone has "decided to act".

    Measured: At baseline

  2. Stage of Adoption for Decision-Making About Lung Screening

    Stage of Adoption for Decision-Making About Lung Screening will be assessed with an algorithm of questions used in the investigator's prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow us to assess intent if someone has "decided to act".

    Measured: Up to 24 hours post-intervention

  3. Stage of Adoption for Decision-Making About Lung Screening

    Stage of Adoption for Decision-Making About Lung Screening will be assessed with an algorithm of questions used in the investigator's prior studies assessing the 7 stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). This will allow us to assess intent if someone has "decided to act".

    Measured: At six-months post-intervention

  4. Medical Mistrust

    Medical Mistrust will be measured using the psychometrically validated 5-item scale with items ranging from 5 (low mistrust) to 25 (high mistrust). This measure assesses constructs related to mistrust of the medical system including suspicion, discrimination, and lack of support. Reliability and validity have been well established with Cronbach's alpha of 0.87-0.88.

    Measured: At baseline

  5. Medical Mistrust

    Medical Mistrust will be measured using the psychometrically validated 5-item scale with items ranging from 5 (low mistrust) to 25 (high mistrust). This measure assesses constructs related to mistrust of the medical system including suspicion, discrimination, and lack of support. Reliability and validity have been well established with Cronbach's alpha of 0.87-0.88.

    Measured: Up to 24 hours post-intervention

  6. Medical Mistrust

    Medical Mistrust will be measured using the psychometrically validated 5-item scale with items ranging from 5 (low mistrust) to 25 (high mistrust). This measure assesses constructs related to mistrust of the medical system including suspicion, discrimination, and lack of support. Reliability and validity have been well established with Cronbach's alpha of 0.87-0.88.

    Measured: At six-months post-intervention

  7. Perceived Smoking-Related Stigma

    Perceived Smoking-Related Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale ranging from 5 (low perceived stigma) to 25 (high perceived stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.

    Measured: At baseline

  8. Perceived Smoking-Related Stigma

    Perceived Smoking-Related Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale ranging from 5 (low perceived stigma) to 25 (high perceived stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.

    Measured: Up to 24 hours post-intervention

  9. Perceived Smoking-Related Stigma

    Perceived Smoking-Related Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale ranging from 5 (low perceived stigma) to 25 (high perceived stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.

    Measured: At six-months post-intervention

  10. Knowledge of Lung Cancer and Lung Screening

    Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in the investigator's preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. Range of scores is 0 (no knowledge) to 7 (high level of knowledge).

    Measured: At baseline

  11. Knowledge of Lung Cancer and Lung Screening

    Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in the investigator's preliminary studies adapted from literature specific to lung cancer. Several aspects will be assessed, including knowledge of lung cancer, risk, and screening. Range of scores is 0 (no knowledge) to 7 (high level of knowledge).

    Measured: Up to 24 hours post-intervention

  12. Perceived Barriers to Lung Cancer Screening Scale

    Perceived Barriers to Lung Cancer Screening 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 the investigator's preliminary psychometric study.

    Measured: At baseline

  13. Perceived Barriers to Lung Cancer Screening Scale

    Perceived Barriers to Lung Cancer Screening 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 the investigator's preliminary psychometric study.

    Measured: Up to 24 hours post-intervention

  14. Perceived Barriers to Lung Cancer Screening Scale

    Perceived Barriers to Lung Cancer Screening 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 the investigator's preliminary psychometric study.

    Measured: At six-months post-intervention

  15. Social Influence Scale

    Social Influence will be measured with 4 items adapted from the Social Influence Scale measuring factors associated with lung screening across gender, ethnicity, and prior screening. Responses range from 1=not important to 4=very important. Cronbach's alpha was 0.81 in the investigator's community-based prior study.

    Measured: At baseline

  16. Social Influence Scale

    Social Influence will be measured with 4 items adapted from the Social Influence Scale measuring factors associated with lung screening across gender, ethnicity, and prior screening. Responses range from 1=not important to 4=very important. Cronbach's alpha was 0.81 in the investigator's community-based prior study.

    Measured: Up to 24 hours post-intervention

  17. Social Influence Scale

    Social Influence will be measured with 4 items adapted from the Social Influence Scale measuring factors associated with lung screening across gender, ethnicity, and prior screening. Responses range from 1=not important to 4=very important. Cronbach's alpha was 0.81 in the investigator's community-based prior study.

    Measured: At six-months post-intervention

  18. Sharing Screening Information with Others

    The dichotomous question, "Have you shared information about lung screening with others?" will be asked. If yes, an open-ended response space will be offered to elaborate.

    Measured: At six-months post-intervention

  19. Built Environment

    Built environment will be measured for each church community and community site calculating attributes using a ½ mile buffer area around the church or community site and include distance to 1) public transportation, 2) nearest lung cancer screening facility, and 3) nearest public health facility with primary care or family medicine.

    Measured: At baseline

Timeline

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

  1. First posted28 Aug 2026
  2. Study start15 Jan 2027 (estimated)
  3. Primary completion15 Jul 2030 (estimated)
  4. Study completion1 Aug 2032 (estimated)

Resources

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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07792824
Sponsor's protocol ID
Pro2026-0407
Other IDs
1R01CA315494-01
Status last verified
Aug 2026
First submitted
19 Aug 2026
Last updated
28 Aug 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
  • De Marchis EH, Brown E, Aceves B, et al. State of the Science of Screening in Healthcare Settings. Social Interventions Research & Evaluation Network, 2022.

  • American Lung Association: State of Lung Cancer. In. Chicago, IL: American Lung Association; 2019.

  • United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening.http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/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
  • 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
  • Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004 Feb;38(2):209-18. doi: 10.1016/j.ypmed.2003.09.041.

    PubMed 14715214
  • Carter-Harris L, Hall LA. Development of a short version of the Cataldo Lung Cancer Stigma Scale. J Psychosoc Oncol. 2014;32(6):665-77. doi: 10.1080/07347332.2014.955238.

    PubMed 25157591

Questions about this trial

What is this clinical trial studying?

A study testing Witness Project Lung and General Educational Program in people with Lung Cancer, run by Hackensack Meridian Health at 1 site 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 5 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: opening soon, as of the sponsor's last update on 28 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 1 site 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 G Vielma, PhD (9566398726, 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?

Effectiveness of Witness Project Lung: Screening Uptake (time frame: At baseline). 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 NCT07792824, which also lists 17 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 28 Aug 2026.

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