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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Social determinants of health screening assessment and referral process; Behavioral: Current practice - Community-based lunch cancer screening (LungTalk)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Nutley, New Jersey, United States, 07110
      • Hackensack Meridian Health - Center for Discovery and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Social determinants of health screening; 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; 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.; Behavioral: Current practice - Community-based lunch cancer screening (LungTalk); 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.
Active Comparator: Community-based lung cancer screening; Participants will receive a community-based lung cancer screening educational tool.	Behavioral: Current practice - Community-based lunch cancer screening (LungTalk); 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.

What is the study measuring?

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)	1 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
Medical Mistrust	Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)	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)	Baseline
Lung Cancer Fatalism	Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)	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).	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).	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".	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)	1 months post intervention
Medical Mistrust	Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust)	1 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)	1 months post intervention
Lung Cancer Fatalism	Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism)	1 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).	1 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).	1 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".	1 months post intervention

Collaborators and Investigators

• Sponsor: Hackensack Meridian Health
• Collaborators: Becton, Dickinson and Company
• Investigators: Principal Investigator: Lisa Carter-Bawa, PhD, Hackensack Meridian Health

Publications and helpful links

General Publications

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
• Carter-Harris L, Brandzel S, Wernli KJ, Roth JA, Buist DSM. A qualitative study exploring why individuals opt out of lung cancer screening. Fam Pract. 2017 Apr 1;34(2):239-244. doi: 10.1093/fampra/cmw146.
• Carter-Harris L, Ceppa DP, Hanna N, Rawl SM. Lung cancer screening: what do long-term smokers know and believe? Health Expect. 2017 Feb;20(1):59-68. doi: 10.1111/hex.12433. Epub 2015 Dec 23.
• Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
• Carter-Harris L, Slaven JE 2nd, Monohan P, Rawl SM. Development and Psychometric Evaluation of the Lung Cancer Screening Health Belief Scales. Cancer Nurs. 2017 May/Jun;40(3):237-244. doi: 10.1097/NCC.0000000000000386.
• Cancer Facts & Figures 2023. American Cancer Society, Inc.; 2022. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2023-cancer-facts-figures.html
• Pettit N, Ceppa D, Monahan P. Low Rates of Lung and Colorectal Cancer Screening Uptake Among a Safety-net Emergency Department Population. West J Emerg Med. 2022 Aug 11;23(5):739-745. doi: 10.5811/westjem.2022.5.55351.
• Mohan G, Chattopadhyay S. Cost-effectiveness of Leveraging Social Determinants of Health to Improve Breast, Cervical, and Colorectal Cancer Screening: A Systematic Review. JAMA Oncol. 2020 Sep 1;6(9):1434-1444. doi: 10.1001/jamaoncol.2020.1460.
• Weinstein D. The Precaution Adoption Process Model. In: Health Behavior and Health Education: Theory, Researchm and Practice. 4th Ed. Jossey-Bass; 2008:123-147.
• Thompson HS, Valdimarsdottir HB, Winkel G, Jandorf L, Redd W. The Group-Based Medical Mistrust Scale: psychometric properties and association with breast cancer screening. Prev Med. 2004 Feb;38(2):209-18. doi: 10.1016/j.ypmed.2003.09.041.
• Cataldo JK, Slaughter R, Jahan TM, Pongquan VL, Hwang WJ. Measuring stigma in people with lung cancer: psychometric testing of the cataldo lung cancer stigma scale. Oncol Nurs Forum. 2011 Jan;38(1):E46-54. doi: 10.1188/11.ONF.E46-E54.
• Mayo RM, Ureda JR, Parker VG. Importance of fatalism in understanding mammography screening in rural elderly women. J Women Aging. 2001;13(1):57-72. doi: 10.1300/J074v13n01_05.
• Carter-Harris L, Slaven JE 2nd, Monahan PO, Draucker CB, Vode E, Rawl SM. Understanding lung cancer screening behaviour using path analysis. J Med Screen. 2020 Jun;27(2):105-112. doi: 10.1177/0969141319876961. Epub 2019 Sep 24.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2023
• Primary Completion (Actual): August 19, 2025
• Study Completion (Actual): August 19, 2025

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: screening; lung cancer screening; social determinants of health
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: Pro2023-0374

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No