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NCT Number: NCT07792824

Witness Project Lung

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - Center for Discovery and Innovation

Nutley, New Jersey, 07110, United States

Location contact

Maureen Ghosh

CONTACT

[email protected]

201-880-3400

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Witness Project Lung

Behavioral

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 Program

Behavioral

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

Primary outcomes

  1. Effectiveness of Witness Project Lung: Screening Uptake

    Time frame: At baseline

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

  2. Effectiveness of Witness Project Lung: Screening Uptake

    Time frame: At six-months post-intervention

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

Secondary outcomes

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

    Time frame: At baseline

    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".

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

    Time frame: Up to 24 hours post-intervention

    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".

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

    Time frame: At six-months post-intervention

    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".

  4. Medical Mistrust

    Time frame: At baseline

    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.

  5. Medical Mistrust

    Time frame: Up to 24 hours post-intervention

    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.

  6. Medical Mistrust

    Time frame: At six-months post-intervention

    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.

  7. Perceived Smoking-Related Stigma

    Time frame: At baseline

    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.

  8. Perceived Smoking-Related Stigma

    Time frame: Up to 24 hours post-intervention

    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.

  9. Perceived Smoking-Related Stigma

    Time frame: At six-months post-intervention

    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.

  10. Knowledge of Lung Cancer and Lung Screening

    Time frame: At baseline

    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).

  11. Knowledge of Lung Cancer and Lung Screening

    Time frame: Up to 24 hours post-intervention

    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).

  12. Perceived Barriers to Lung Cancer Screening Scale

    Time frame: At baseline

    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.

  13. Perceived Barriers to Lung Cancer Screening Scale

    Time frame: Up to 24 hours post-intervention

    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.

  14. Perceived Barriers to Lung Cancer Screening Scale

    Time frame: At six-months post-intervention

    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.

  15. Social Influence Scale

    Time frame: At baseline

    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.

  16. Social Influence Scale

    Time frame: Up to 24 hours post-intervention

    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.

  17. Social Influence Scale

    Time frame: At six-months post-intervention

    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.

  18. Sharing Screening Information with Others

    Time frame: At six-months post-intervention

    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.

  19. Built Environment

    Time frame: At baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana G Vielma, PhD

CONTACT

[email protected]

9566398726

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2027
Primary completion
2030
Study completion
2032
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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