Clinical trial NCT06052449: Assessing Social Determinants of Health to Increase Cancer Screening
Official title: Assessing Social Determinants of Health to Increase Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: screening
social determinants of health
lung cancer screening
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: Becton, Dickinson and Company
First posted: 2023-09-25
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lung cancer screening uptake
timeFrame: 3 months post intervention
Secondary outcomes:
measure: Health Literacy
timeFrame: Baseline
measure: Health Literacy
timeFrame: 3 months post intervention
measure: Medical Mistrust
timeFrame: Baseline
measure: Medical Mistrust
timeFrame: 3 months post intervention
measure: Perceived Smoking-Related Stigma
timeFrame: Baseline
measure: Perceived Smoking-Related Stigma
timeFrame: 3 months post intervention
measure: Lung Cancer Fatalism
timeFrame: Baseline
measure: Lung Cancer Fatalism
timeFrame: 3 months post intervention
measure: Knowledge of Lung Cancer and Lung Screening
timeFrame: Baseline
measure: Knowledge of Lung Cancer and Lung Screening
timeFrame: 3 months post intervention
measure: Perceived Barriers to Lung Cancer Screening Scale
timeFrame: Baseline
measure: Perceived Barriers to Lung Cancer Screening Scale
timeFrame: 3 months post intervention
measure: Stage of Adoption for Decision-Making About Lung Screening
timeFrame: Baseline
measure: Stage of Adoption for Decision-Making About Lung Screening
timeFrame: 3 months post intervention
Other outcomes:
Locations:
city: Nutley
country: United States
facility: Hackensack Meridian Health - Center for Discovery and Innovation
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Lisa Carter-Bawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Weinstein D. The Precaution Adoption Process Model. In: Health Behavior and Health Education: Theory, Researchm and Practice. 4th Ed. Jossey-Bass; 2008:123-147.
citation: Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.