Hackensack Meridian Health - Center for Discovery and Innovation
Nutley, New Jersey, 07110, United States
NCT Number: NCT07792824
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.
Trial opening soon.
Get Notified50 year–80 year
All sexes
Interventional
Not applicable
Nutley, New Jersey, 07110, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
Time frame: At baseline
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
Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan).
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".
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".
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".
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Hackensack Meridian Health
Other
CLEAR-LUNG (Community-Level Effectiveness to Advance Reach in Lung Cancer Screening)
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