Witness Project Lung

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorHackensack Meridian Health

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Witness Project LungExperimental treatment 1 intervention
Group B: General Educational ProgramActive comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame
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).

Time frame
At six-months post-intervention

Secondary outcomes

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".

Time frame
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".

Time frame
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".

Time frame
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.

Time frame
At baseline

Other outcomes

Sponsors and contacts

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Hackensack Meridian Health

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: