Witness Project Lung

NCT07792824 | Not Yet Recruiting

• 2 other identifiers: Pro2026-04071R01CA315494-01
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. The short-term objective of this study is to rigorously test the effectiveness, mechanisms, and implementation readiness of Witness Project® Lung.

Conditions

Lung Cancer

Keywords

lung cancer screening; community setting; tailored intervention

Outcome Measures

Primary Outcomes (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).

  At baseline

• 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).

  At six-months post-intervention

Secondary Outcomes (19)

• Stage of Adoption for Decision-Making About Lung Screening

  At baseline

• Stage of Adoption for Decision-Making About Lung Screening

  Up to 24 hours post-intervention

• Stage of Adoption for Decision-Making About Lung Screening

  At six-months post-intervention

• Medical Mistrust

  At baseline

• Medical Mistrust

  Up to 24 hours post-intervention

Study Arms (2)

Witness Project Lung

EXPERIMENTAL

This 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.

Behavioral: Witness Project Lung

General Educational Program

ACTIVE COMPARATOR

A 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.

Behavioral: General Educational Program

Interventions

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.

Witness Project Lung

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

General Educational Program

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Meridian Health - Center for Discovery and Innovation

Nutley, New Jersey, 07110, United States

Location

Related Publications (17)

• 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.

  PMID: 33532112 BACKGROUND

• De Marchis EH, Brown E, Aceves B, et al. State of the Science of Screening in Healthcare Settings. Social Interventions Research & Evaluation Network, 2022.

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 33000953 BACKGROUND

• 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.

  PMID: 27241830 BACKGROUND

• 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.

  PMID: 21714641 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 26701339 BACKGROUND

• 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.

  PMID: 28122849 BACKGROUND

• 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.

  PMID: 29552458 BACKGROUND

• 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.

  PMID: 31550991 BACKGROUND

• 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.

  PMID: 31560837 BACKGROUND

• 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.

  PMID: 14715214 BACKGROUND

• 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.

  PMID: 25157591 BACKGROUND

• Carter-Harris L, Slaven JE 2nd, Monohan P, Rawl SM. Development and Psychometric Evaluation of the Lung Cancer Screening Health Belief Scales. Cancer Nurs. 2017 May/Jun;40(3):237-244. doi: 10.1097/NCC.0000000000000386.

  PMID: 27244666 BACKGROUND

• Weinstein D. The Precaution Adoption Process Model. In: Glanz K, Rimer BK, Viswanath K, eds. Health behavior and health education: Theory, research, and practice, 4th ed. 4th ed. San Francisco, CA, US: Jossey-Bass; 2008:xxxiii-552, pp. 123-147.

  BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lisa Carter-Bawa, PhD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana G Vielma, PhD

CONTACT

9566398726; Ana.vielma@hmh-cdi.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): July 15, 2030
• Study Completion (Estimated): August 1, 2032
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)