Assessing Social Determinants of Health to Increase Cancer Screening

Study Overview
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Brief Summary
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A multilevel lung screening intervention that pairs Social Determinants of Health (SDoH) screening and referral with a tailored health communication and decision support tool for lung screening has the potential to significantly impact lung screening uptake among at-risk individuals in the community, particularly among those who face barriers related to SDoH. In addition, findings will advance the understanding of effective strategies for improving lung screening and prevention efforts in non-traditional settings, with the ultimate goal of reducing the burden of lung cancer. As ways to support the realization of the public health benefit of lung cancer screening are considered, multiple strategies and venues to reach, and intervene, with screening-eligible is key. The goal of this study is to compare the effectiveness of a community-based lung screening educational tool paired with a social determinants of health (SDoH) screening assessment and referral process compared to a community-based lung cancer screening (LCS) educational tool alone as part of community outreach activities to improve (a) LCS rates (primary outcome); (b) intention to screen; and (c) individual-level potential drivers of LCS (health literacy, mistrust, stigma, fatalism, knowledge, health beliefs). It is hypothesized that providing SDoH screening and referral will result in higher levels of LCS, forward movement of intention to screen, and improved individual-level drivers of LCS.

Detailed Description
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The study will be a pilot randomized controlled trial (RCT) to compare primary (LCS uptake) and secondary outcomes (intent to screen, literacy, mistrust, stigma, fatalism, health beliefs) among LCS-eligible men and women in New Jersey community-based settings who receive a community-based LCS educational tool paired with a social determinants of health (SDoH) screening assessment and referral process (n=50) compared to a community-based LCS educational tool alone (n=50) as part of community outreach activities. All individuals who attend a community event are normally assessed for cancer risks and appropriate cancer screening education is provided. For those who are eligible for LCS, they will also be invited to participate in this study.

Official Title
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Assessing Social Determinants of Health to Increase Cancer Screening

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Social determinants of health screening assessment and referral process
* Behavioral: Current practice - Community-based lunch cancer screening (LungTalk)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 50 years to 80 years Currently smoke or quit smoking within the past 15 years 20 pack-year smoking history Has never had lung cancer screening Able to provide informed consent Able to speak and understand English Exclusion Criteria: Diagnosed with lung cancer Has a history of having a lung cancer screening scan Unable to speak and understand English

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Social determinants of health screening<br>Participants will receive a social determinants of health screening assessment and referral process in addition to the community-based lung cancer screening educational tool. | Behavioral: Social determinants of health screening assessment and referral process<br>* Unite Us is an electronic SDoH screening and referral tool assessing: (1) financial resource strain; (2) housing stability; (3) transportation needs; and (4) food insecurity. Upon completion, the Unite Us platform identifies a list of geographically-tailored resources to connect the individual in need. A staff member will administer the SDoH screening and referral tool, review the results with the participant, and use the geographically-tailored resources to make SDoH-related referrals.<br>Behavioral: Current practice - Community-based lunch cancer screening (LungTalk)<br>* The current practice during community events is to offer LungTalk. LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled LCS knowledge and health beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% Confidence Interval (CI), 1.03, 3.85, p = 0.03.<br>|
| Active Comparator: Community-based lung cancer screening<br>Participants will receive a community-based lung cancer screening educational tool. | Behavioral: Current practice - Community-based lunch cancer screening (LungTalk)<br>* The current practice during community events is to offer LungTalk. LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled LCS knowledge and health beliefs (p < 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% Confidence Interval (CI), 1.03, 3.85, p = 0.03.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung cancer screening uptake | Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan) | 3 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Literacy | Health Literacy will be measured using the 3-item health literacy scale ranging from 0 (low health literacy level) to 12 (high health literacy level) | Baseline | 
| Health Literacy | Health Literacy will be measured using the 3-item health literacy scale ranging from 0 (low health literacy level) to 12 (high health literacy level) | 3 months post intervention | 
| Medical Mistrust | Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust) | Baseline | 
| Medical Mistrust | Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust) | 3 months post intervention | 
| Perceived Smoking-Related Stigma | 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) | Baseline | 
| Perceived Smoking-Related Stigma | 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) | 3 months post intervention | 
| Lung Cancer Fatalism | Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism) | Baseline | 
| Lung Cancer Fatalism | Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism) | 3 months post intervention | 
| Knowledge of Lung Cancer and Lung Screening | Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our 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). | Baseline | 
| Knowledge of Lung Cancer and Lung Screening | Knowledge of Lung Cancer and Lung Screening will be assessed with a 7-item multidimensional scale used in our 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). | 3 months post intervention | 
| Perceived Barriers to Lung Cancer Screening Scale | Perceived Barriers to Lung Cancer Screening Scale will be used ranging from 17 (low perceived barriers to lung screening) to 68 (high perceived barriers to lung screening). | Baseline | 
| Perceived Barriers to Lung Cancer Screening Scale | Perceived Barriers to Lung Cancer Screening Scale will be used ranging from 17 (low perceived barriers to lung screening) to 68 (high perceived barriers to lung screening). | 3 months post intervention | 
| 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 our 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. | Baseline | 
| 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 our 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. | 3 months post intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, social determinants of health, lung cancer screening