Lung Cancer
Conditions
Keywords
lung cancer screening, community setting, tailored intervention
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.
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.
Interventions
BEHAVIORALWitness Project Lung
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.
BEHAVIORALGeneral Educational 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
Sponsors
Hackensack Meridian Health
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Witness Project Lung: Screening Uptake | At baseline | Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stage of Adoption for Decision-Making About Lung Screening | 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". |
| Medical Mistrust | 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. |
| Perceived Smoking-Related Stigma | 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. |
| Knowledge of Lung Cancer and Lung Screening | 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). |
| Perceived Barriers to Lung Cancer Screening Scale | 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. |
| Social Influence Scale | 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. |
| Sharing Screening Information with Others | 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. |
| Built Environment | 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. |
Countries
United States
Contacts
CONTACTAna G Vielma, PhD
PRINCIPAL_INVESTIGATORLisa Carter-Bawa, PhD
Hackensack Meridian Health
Outcome results
None listed