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OpenTrials
Completed

NCT Number: NCT06052449

Assessing Social Determinants of Health to Increase Cancer Screening

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hackensack Meridian Health - Center for Discovery and Innovation

Nutley, New Jersey, 07110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Social determinants of health screening assessment and referral process

Behavioral

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.

Current practice - Community-based lunch cancer screening (LungTalk)

Behavioral

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.

Primary outcomes

  1. Lung Cancer Screening Uptake

    Time frame: 1 months post intervention

    Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan)

Secondary outcomes

  1. Health Literacy

    Time frame: Baseline

    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)

  2. Health Literacy

    Time frame: 1 months post intervention

    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. Medical Mistrust

    Time frame: Baseline

    Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)

  4. Medical Mistrust

    Time frame: 1 months post intervention

    Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)

  5. Perceived Smoking-Related Stigma

    Time frame: 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)

  6. Perceived Smoking-Related Stigma

    Time frame: 1 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)

  7. Lung Cancer Fatalism

    Time frame: Baseline

    Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)

  8. Lung Cancer Fatalism

    Time frame: 1 months post intervention

    Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)

  9. Knowledge of Lung Cancer and Lung Screening

    Time frame: Baseline

    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).

  10. Knowledge of Lung Cancer and Lung Screening

    Time frame: 1 months post intervention

    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).

  11. Perceived Barriers to Lung Cancer Screening Scale

    Time frame: Baseline

    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).

  12. Perceived Barriers to Lung Cancer Screening Scale

    Time frame: 1 months post intervention

    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).

  13. Stage of Adoption for Decision-Making About Lung Screening

    Time frame: Baseline

    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".

  14. Stage of Adoption for Decision-Making About Lung Screening

    Time frame: 1 months post intervention

    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".

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Collaborators

  • Becton, Dickinson and Company

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2023
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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