Health Communication Tool + SDoH Screening for Lung Cancer

Overseen By Francis Valenzona

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Lung cancer, Prior screening, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a social factors check-up and referral process increases lung cancer screening rates compared to using only a lung cancer education tool (LungTalk). The study targets individuals who currently smoke or quit smoking within the last 15 years and have never been screened for lung cancer. It seeks to discover if addressing social challenges can boost screening rates and alter perceptions about screening. Participants must speak and understand English and have a history of smoking at least 20 pack-years (equivalent to smoking one pack a day for 20 years). As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance lung cancer screening processes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this intervention is safe?

Research has shown that checking and referring people based on social factors affecting health is generally well-received by participants. Although specific data on negative effects from these screenings is limited, studies indicate they usually don't pose safety risks. These screenings aim to identify non-medical issues, like access to food or housing, that can affect health, meaning no direct medical treatments are involved that could cause physical harm.

Conversely, LungTalk is a community-based educational tool about lung cancer screening, designed to increase awareness and understanding. As an educational resource rather than a medical treatment, it doesn't carry safety risks.

In summary, both the social health screenings and the LungTalk educational tool are safe and non-invasive for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines lung cancer screening with a unique focus on the social determinants of health (SDoH). Unlike traditional lung cancer screening methods that primarily focus on medical indicators, this approach adds a layer of screening to identify social factors like access to care, housing, and nutrition, which can influence health outcomes. By addressing these broader factors, the trial aims to provide a more comprehensive understanding of patient needs and potentially improve access to timely care and support. This could lead to more personalized and effective interventions for lung cancer patients, which is why researchers are hopeful about its potential impact.

What evidence suggests that this trial's treatments could be effective for improving lung cancer screening rates?

This trial will compare two approaches to lung cancer screening. Participants in one arm will receive a community-based lung cancer screening educational tool. In the other arm, participants will receive the same educational tool along with a social determinants of health screening assessment and referral process. Studies have shown that addressing social factors can improve cancer screening rates. Research indicates that when people receive help with transportation, housing, and food, they are more likely to complete lung cancer screenings. Solving these problems increases the number of people who get screened. Early findings suggest that using a personalized health communication tool, combined with checking for these social factors, may further boost screening rates and willingness to get screened. This approach aims to make lung cancer screening more accessible and effective, especially for those facing social and economic challenges. ^{1 2 3 4 6}

Who Is on the Research Team?

Lisa Carter-Bawa, PhD

Principal Investigator

Hackensack Meridian Health

Are You a Good Fit for This Trial?

This trial is for individuals aged 50-80 who can consent, currently smoke or quit within the last 15 years, have a history of significant smoking (20 pack-years), and have never had lung cancer screening. They must speak and understand English. Those with previous lung screenings or diagnosed with lung cancer are excluded.

Inclusion Criteria

I am between 50 and 80 years old.

Able to provide informed consent

You currently smoke or quit smoking within the past 15 years.

Exclusion Criteria

You have previously had a lung cancer screening scan.

I have been diagnosed with lung cancer.

Unable to speak and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Intervention

Participants receive a community-based lung cancer screening educational tool, with or without a social determinants of health screening assessment and referral process

1 day

1 visit (in-person)

Follow-up

Participants are monitored for lung cancer screening uptake and changes in individual-level drivers of lung cancer screening

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Current practice - Community-based lung cancer screening (LungTalk)
• Social determinants of health screening assessment and referral process

Trial Overview The study tests if adding a Social Determinants of Health (SDoH) assessment and referral process to a community-based educational tool improves lung cancer screening rates compared to just the educational tool alone in at-risk communities.

How Is the Trial Designed?

Group I: Social determinants of health screening Experimental Treatment 2 Interventions

Participants will receive a social determinants of health screening assessment and referral process in addition to the community-based lung cancer screening educational tool.

Group II: Community-based lung cancer screening Active Control 1 Intervention

Participants will receive a community-based lung cancer screening educational tool.

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

Becton, Dickinson and Company

Industry Sponsor

Trials

80

Recruited

92,000+

Tom Polen

Becton, Dickinson and Company

Chief Executive Officer since 2020

Bachelor’s degree from Salisbury University, MBA from Johns Hopkins University

Meera Gopalakrishnan

Becton, Dickinson and Company

Chief Medical Officer

Ph.D. in Biomedical Engineering from the University of Memphis

Published Research Related to This Trial

A mobile lung cancer screening program in New York City successfully screened 216 patients, reaching a younger and more diverse demographic compared to traditional hospital-based screenings, which may help increase early detection of lung cancer.

The program identified lung cancer in 2 patients and significant non-lung cancer findings in 28.2% of participants, demonstrating the effectiveness of mobile screening in detecting serious health issues and the need for targeted outreach to high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results from Lung Cancer Screening Outreach Utilizing a Mobile CT Scanner in an Urban Area. Pua, BB., O'Neill, BC., Ortiz, AK., et al.[2023]

A focus group study involving 54 participants from Appalachian Kentucky revealed that most individuals were previously unaware of lung cancer screening with low-dose computed tomography (LDCT), highlighting the need for effective awareness campaigns.

Participants emphasized the importance of messaging that includes personal testimonies, hope, and the benefits of early detection, suggesting that communication from trusted healthcare providers is crucial for promoting lung cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Community Perspectives for a Lung Cancer Screening Awareness Campaign in Appalachia Kentucky: The Terminate Lung Cancer (TLC) Study. Cardarelli, R., Roper, KL., Cardarelli, K., et al.[2018]

In a study conducted at an urban Native American clinic, two culturally targeted promotion strategies for lung cancer screening resulted in low scheduling rates for shared decision-making visits, with only 8.5% of eligible patients participating.

Despite ordering lung cancer screening CT exams, only about 50% of those exams were completed, highlighting a significant gap that suggests the need for more effective interventions to encourage follow-through on screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening Outreach Program in an Urban Native American Clinic. Robichaux, C., Anderson, M., Freese, R., et al.[2023]

A study of 438 individuals in Indiana revealed that sociodemographic factors such as race, geographic location, income, and health insurance significantly influence lung cancer screening behavior.

The research identified disparities in screening participation based on race and residence, highlighting the need for targeted outreach and educational programs to improve screening rates among underrepresented groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers. Carter-Harris, L., Slaven, JE., Monahan, PO., et al.[2023]

Education delivered by community health advisors significantly improved lung cancer screening knowledge among high-risk individuals in Alabama, with knowledge scores increasing from an average of 4.64 to 7.61 after the intervention.

Despite the increase in knowledge, only 23 out of 100 participants underwent lung cancer screening, highlighting that structural barriers, such as lack of access to primary care and reluctance from providers, still limit effective utilization of lung cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Community Health Advisors to Increase Lung Cancer Screening Awareness in the Black Belt: a Pilot Study. Niranjan, SJ., Opoku-Agyeman, W., Hardy, CM., et al.[2023]

Out of 2,797 patients with scheduled lung cancer screening appointments, 32.7% of appointments were missed, highlighting a significant issue with adherence to screening protocols.

Social determinants of health, such as being self-reported Black or having Medicaid insurance, were linked to higher odds of missing appointments, indicating that targeted interventions are needed to address these disparities and improve access to lung cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Social Determinants of Health on Lung Cancer Screening Utilization. Shin, D., Fishman, MDC., Ngo, M., et al.[2023]

The Lung AIR intervention effectively increased knowledge and reduced fear about lung cancer screening among 292 participants, demonstrating its feasibility as a community-based educational program.

One-on-one phone sessions were particularly effective, leading to greater increases in participants' intention to complete screening compared to in-person group sessions, especially among those with lower income and higher smoking rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting Community Educational Programs During the COVID-19 Pandemic: Comparing the Feasibility and Efficacy of a Lung Cancer Screening Educational Intervention by Mode of Delivery. Bouchard, EG., Saad-Harfouche, FG., Clark, N., et al.[2023]

In New York state, nearly half (48.3%) of lung cancer patients were diagnosed with late-stage disease, highlighting the need for improved access to lung cancer screening resources, especially in rural areas.

The study found that rural counties had fewer lung cancer screening centers and higher lung cancer mortality rates, indicating that geographic disparities in healthcare resources significantly impact patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multilevel Approach to Investigate Relationships Between Healthcare Resources and Lung Cancer. Somayaji, D., Seo, YS., Wilding, GE., et al.[2023]

The NHS England leaflet for the Targeted Lung Health Check (TLHC) program was generally well-received by 40 current and former smokers aged 55-73, helping them understand the screening process and fostering positive intentions towards participation.

Participants expressed anxiety about potential screening results but felt reassured by the involvement of healthcare professionals; however, they struggled with understanding certain risks and eligibility criteria, indicating a need for clearer communication to support informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a standalone written leaflet for the National Health Service for England Targeted Lung Health Check Programme: A concurrent, think-aloud study. Jallow, M., Black, G., van Os, S., et al.[2022]

A study involving 18 high-risk patients in Toronto revealed that socioeconomic factors significantly influence the decision to participate in lung cancer screening, highlighting the need for tailored interventions.

The research identified key themes such as the impact of social disadvantages on health-seeking behavior and the importance of creating non-judgmental healthcare environments to improve access to lung cancer screening for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advancing health equity in cancer care: The lived experiences of poverty and access to lung cancer screening. Sayani, A., Vahabi, M., O'Brien, MA., et al.[2021]

Lung cancer screening using low-dose computed tomography can significantly improve survival rates, yet it remains underutilized, especially among rural populations in the United States.

This scoping review aims to identify the barriers and facilitators affecting the uptake and adherence to lung cancer screening in rural areas, focusing on studies published since 2013 that meet specific inclusion criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and facilitators for low-dose computed tomography lung cancer screening in rural populations in the United States: a scoping review protocol. Palokas, M., Hinton, E., Duhe, R., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06052449

Assessing Social Determinants of Health to Increase ... A multilevel lung screening intervention that pairs Social Determinants of Health (SDoH) screening and referral with a tailored health communication and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9175338/

Social determinants of health and cancer screening ... We will summarize recent literature on SDOH and cancer screening, identify research gaps for inclusion of SDOH, and propose future opportunities for advancing ...

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21801

Social determinants of health and US cancer screening ... Data items included study and intervention characteristics, SDOH intervention components and measures, and screening outcomes. The findings were ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8820269/

The Impact of Social Determinants of Health on Lung ... The purpose of this study is to understand how social determinants of health (SDOH) may influence lung cancer screening (LCS) adherence.

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/133519

Social determinants of health and U.S. cancer screening ... This review describes how SDOH have been considered in the design and evaluation of cancer screening interventions and effect sizes for SDOH interventions.

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213538325000050

State law at the intersection of lung cancer screening ... Lung cancer is a significant public health issue and social determinants of health (SDOH) may contribute to lung cancer disparities. Given the racial/ethnic ...