Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-27 @ 11:40 PM
Study NCT ID:
NCT06605534
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2024-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leveraging the Emergency Department (LEAD) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2024-09-11', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lung Cancer Screening Uptake', 'timeFrame': 'Assessed at 1 month and 6 months post intervention', 'description': 'Completion of a Screening Low-Dose Computed Tomography (LDCT) of the Chest confirmed via Electronic Health Records (EHR))'}, {'measure': 'Stage of Adoption for Lung Cancer Screening', 'timeFrame': 'Assessed at 1 week and then at 1 month and 6 months post intervention', 'description': 'Screening Intention will be assessed with the Stage of Adoption for Decision- Making About Lung Screening using 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 investigators to assess intent.'}], 'secondaryOutcomes': [{'measure': 'Health Literacy Scale', 'timeFrame': 'At one week and one month post intervention', 'description': 'Change in Health Literacy Scale between baseline and 1 week and 1-month post-intervention. The Health Literacy Scale will be measured using the 3-item psychometrically validated Health Literacy Scale by Chew and colleagues. This scale has been supported as valid for detecting inadequate health literacy using Likert scale response options ranging from 0=strongly disagree to 4 =strongly agree with lower scores representative of higher levels of health literacy.'}, {'measure': 'Medical Mistrust Scale', 'timeFrame': 'At one week and one month post intervention', 'description': "Change in Medical Mistrust Scale between baseline and 1 week and 1-month post-intervention. Medical Mistrust will be measured using the psychometrically validated 5-item Medical Mistrust Scale. This measure assesses constructs related to mistrust of the medical system, including suspicion, discrimination, and lack of support. Likert scale response options range from 1 to 4 with 1=Stongly Disagree to Agree 5=Strongly. Responses are summed (range 5-25), with higher scores indicating more trust. \\*Negatively worded item is reverse coded. Reliability and validity have been well established with Cronbach's alpha of 0.87-0.88."}, {'measure': 'Perceived Stigma Scale', 'timeFrame': 'At one week and one month post intervention', 'description': "Change in Perceived Stigma Scale between baseline and 1 week and 1-month post-intervention. Perceived Stigma will be measured using the 5-item smoking-related stigma subscale of the Cataldo Lung Cancer Stigma Scale. The response scale is 1=strongly disagree to 4=strongly agree; range is 5 to 25 (higher stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies."}, {'measure': 'Perceived Risk of Lung Cancer Scale', 'timeFrame': 'At one week and one month post intervention', 'description': "Change in Perceived Risk of Lung Cancer Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Risk of Lung Cancer on a 3-item scale with Likert-type responses from 1=Strongly Disagree to 4=Strongly Agree. The range of scores is 3 to 12 (higher perceived risk of lung cancer). Cronbach's alpha was 0.88 in our preliminary study."}, {'measure': 'Perceived Benefits of Lung Cancer Screening Scale', 'timeFrame': 'At one week and one month post intervention', 'description': "Change in Perceived Benefits of Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Benefits of Lung Cancer Screening on a 6-item scale with responses ranging from 1=strongly disagree to 4=strongly agree. The range of scores is 6 to 24 (higher perceived benefits), with a Cronbach's alpha of 0.76 in our preliminary study"}, {'measure': 'Perceived Barriers to Lung Cancer Screening Scale', 'timeFrame': 'At one week and one month post intervention', 'description': "Change in Perceived Barriers of Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Perceived Barriers to Lung Cancer Screening. This scale has 17 items with four-point Likert responses where 1=strongly disagree and 4=strongly agree. The range of scores is 17 to 68 (higher perceived barriers) with a Cronbach's a of 0.87 in our preliminary psychometric study"}, {'measure': 'Self-Efficacy for Lung Cancer Screening Scale', 'timeFrame': 'At one week and one month post intervention', 'description': "Change in Self-Efficacy for Lung Cancer Screening Scale between baseline and 1 week and 1-month post-intervention. Lung Cancer Screening Health Belief Scales will be used to measure perceived risk, perceived benefits, perceived barriers, and self-efficacy. Content and construct validity have been established. Internal consistency reliability was established by our team with a sample of 497 lung cancer screening-eligible individuals with Self-Efficacy for Lung Cancer Screening. This scale has nine items with a four-point Likert response option (1=Not at all Confident and 4 =Very Confident) to assess individual beliefs about ability to arrange and complete an LDCT to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy) with a Cronbach's alpha of 0.92 in our preliminary psychometric study."}, {'measure': 'Knowledge: Lung Cancer and Screening Scale', 'timeFrame': 'At one week and one month post intervention', 'description': 'Change in Knowledge: Lung Cancer and Lung Screening between baseline and 1 week and 1-month 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. The range of scores is 0 to 7, with 0 being No Knowledge, and 9 being Complete Knowledge.'}, {'measure': 'Lung Cancer Fatalism', 'timeFrame': 'At one week and one month post intervention', 'description': 'Change in Lung Cancer Fatalism between baseline and 1 week and 1-month post-intervention. Lung Cancer Fatalism will be measured with the 11-item dichotomous (0=yes and 1=no) Lung Cancer Fatalism Scale adapted from the Revised Powe Fatalism Inventory that has been psychometrically validated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['screening', 'lung cancer', 'Disparities', 'social determinants of health', 'emergency department'], 'conditions': ['Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '33532112', 'type': 'BACKGROUND', 'citation': "Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available."}, {'type': 'BACKGROUND', 'citation': 'Cancer Facts & Figures for African Americans 2019-2021. In: American Cancer Society. Atlanta: 2019.'}, {'type': 'BACKGROUND', 'citation': 'United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening.http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatem entFinal/lung-cancer-screening. Updated December 2016. Accessed January 21, 2023.'}, {'pmid': '33000953', 'type': 'BACKGROUND', 'citation': 'Rivera MP, Katki HA, Tanner NT, Triplette M, Sakoda LC, Wiener RS, Cardarelli R, Carter-Harris L, Crothers K, Fathi JT, Ford ME, Smith R, Winn RA, Wisnivesky JP, Henderson LM, Aldrich MC. Addressing Disparities in Lung Cancer Screening Eligibility and Healthcare Access. An Official American Thoracic Society Statement. Am J Respir Crit Care Med. 2020 Oct 1;202(7):e95-e112. doi: 10.1164/rccm.202008-3053ST.'}, {'pmid': '27241830', 'type': 'BACKGROUND', 'citation': 'Carter-Harris L, Tan AS, Salloum RG, Young-Wolff KC. Patient-provider discussions about lung cancer screening pre- and post-guidelines: Health Information National Trends Survey (HINTS). Patient Educ Couns. 2016 Nov;99(11):1772-1777. doi: 10.1016/j.pec.2016.05.014. Epub 2016 May 17.'}, {'type': 'BACKGROUND', 'citation': 'American Lung Association: State of Lung Cancer. In. Chicago, IL: American Lung Association; 2019.'}, {'pmid': '21714641', 'type': 'BACKGROUND', 'citation': 'National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.'}, {'type': 'BACKGROUND', 'citation': 'United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening (updated). https://www.uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening. Updated March 9, 2021. Accessed February 21, 2024.'}, {'pmid': '26701339', 'type': 'BACKGROUND', '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.'}, {'pmid': '28122849', 'type': 'BACKGROUND', '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.'}, {'pmid': '29552458', 'type': 'BACKGROUND', 'citation': 'Carter-Harris L, Slaven JE Jr, Monahan PO, Shedd-Steele R, Hanna N, Rawl SM. Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers. Prev Med Rep. 2018 Feb 3;10:49-54. doi: 10.1016/j.pmedr.2018.01.018. eCollection 2018 Jun.'}, {'pmid': '31550991', 'type': 'BACKGROUND', '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.'}, {'pmid': '31560837', 'type': 'BACKGROUND', 'citation': 'Draucker CB, Rawl SM, Vode E, Carter-Harris L. Understanding the decision to screen for lung cancer or not: A qualitative analysis. Health Expect. 2019 Dec;22(6):1314-1321. doi: 10.1111/hex.12975. Epub 2019 Sep 27.'}, {'type': 'BACKGROUND', 'citation': 'De Marchis EH, Brown E, Aceves B, et al. State of the Science of Screening in Healthcare Settings. Social Interventions Research & Evaluation Network, 2022.'}, {'pmid': '19376676', 'type': 'BACKGROUND', 'citation': 'Albada A, Ausems MG, Bensing JM, van Dulmen S. Tailored information about cancer risk and screening: a systematic review. Patient Educ Couns. 2009 Nov;77(2):155-71. doi: 10.1016/j.pec.2009.03.005. Epub 2009 Apr 18.'}, {'pmid': '20558196', 'type': 'BACKGROUND', 'citation': 'Krebs P, Prochaska JO, Rossi JS. A meta-analysis of computer-tailored interventions for health behavior change. Prev Med. 2010 Sep-Oct;51(3-4):214-21. doi: 10.1016/j.ypmed.2010.06.004. Epub 2010 Jun 15.'}, {'type': 'BACKGROUND', 'citation': 'Kreuter M, Farrell D, Olevitch L, et al. Tailoring health messages: Customizing communication with computer technology. Mahwah, NJ, US: Lawrence Erlbaum Associates Publishers; 2000.'}, {'pmid': '22926008', 'type': 'BACKGROUND', 'citation': 'Rawl SM, Skinner CS, Perkins SM, Springston J, Wang HL, Russell KM, Tong Y, Gebregziabher N, Krier C, Smith-Howell E, Brady-Watts T, Myers LJ, Ballard D, Rhyant B, Willis DR, Imperiale TF, Champion VL. Computer-delivered tailored intervention improves colon cancer screening knowledge and health beliefs of African-Americans. Health Educ Res. 2012 Oct;27(5):868-85. doi: 10.1093/her/cys094. Epub 2012 Aug 27.'}, {'pmid': '17689600', 'type': 'BACKGROUND', 'citation': 'Ruffin MT 4th, Fetters MD, Jimbo M. Preference-based electronic decision aid to promote colorectal cancer screening: results of a randomized controlled trial. Prev Med. 2007 Oct;45(4):267-73. doi: 10.1016/j.ypmed.2007.07.003. Epub 2007 Jul 14.'}, {'pmid': '15550305', 'type': 'BACKGROUND', 'citation': 'Ahmad F, Cameron JI, Stewart DE. A tailored intervention to promote breast cancer screening among South Asian immigrant women. Soc Sci Med. 2005 Feb;60(3):575-86. doi: 10.1016/j.socscimed.2004.05.018.'}, {'pmid': '9341350', 'type': 'BACKGROUND', 'citation': 'Champion V, Foster JL, Menon U. Tailoring interventions for health behavior change in breast cancer screening. Cancer Pract. 1997 Sep-Oct;5(5):283-8.'}, {'pmid': '33141096', 'type': 'BACKGROUND', 'citation': 'Carter-Harris L, Comer RS, Slaven Ii JE, Monahan PO, Vode E, Hanna NH, Ceppa DP, Rawl SM. Computer-Tailored Decision Support Tool for Lung Cancer Screening: Community-Based Pilot Randomized Controlled Trial. J Med Internet Res. 2020 Nov 3;22(11):e17050. doi: 10.2196/17050.'}, {'pmid': '29146565', 'type': 'BACKGROUND', 'citation': 'Carter-Harris L, Comer RS, Goyal A, Vode EC, Hanna N, Ceppa D, Rawl SM. Development and Usability Testing of a Computer-Tailored Decision Support Tool for Lung Cancer Screening: Study Protocol. JMIR Res Protoc. 2017 Nov 16;6(11):e225. doi: 10.2196/resprot.8694.'}, {'pmid': '28304262', 'type': 'BACKGROUND', 'citation': 'Carter-Harris L, Davis LL, Rawl SM. Lung Cancer Screening Participation: Developing a Conceptual Model to Guide Research. Res Theory Nurs Pract. 2016 Nov 1;30(4):333-352. doi: 10.1891/1541-6577.30.4.333.'}, {'pmid': '25532218', 'type': 'BACKGROUND', 'citation': 'Lau YK, Caverly TJ, Cherng ST, Cao P, West M, Arenberg D, Meza R. Development and validation of a personalized, web-based decision aid for lung cancer screening using mixed methods: a study protocol. JMIR Res Protoc. 2014 Dec 19;3(4):e78. doi: 10.2196/resprot.4039.'}, {'type': 'BACKGROUND', 'citation': 'Memorial Sloan Kettering Cancer Center, Lung cancer screening decision tool. http://nomograms.mskcc.org/Lung/Screening.aspx. Accessed June 20, 2024.'}, {'type': 'BACKGROUND', 'citation': 'Chen Y, Marcus MW, Niaz A, et al My Lung Risk: a user-friendly, web-based calculator for risk assessment of lung cancer based on the validated Liverpool Lung Project risk prediction model. International Journal of Health Promotion and Education. 2014;52(3):144-152.'}, {'pmid': '24518006', 'type': 'BACKGROUND', 'citation': 'Volk RJ, Linder SK, Leal VB, Rabius V, Cinciripini PM, Kamath GR, Munden RF, Bevers TB. Feasibility of a patient decision aid about lung cancer screening with low-dose computed tomography. Prev Med. 2014 May;62:60-3. doi: 10.1016/j.ypmed.2014.02.006. Epub 2014 Feb 8.'}, {'type': 'BACKGROUND', 'citation': 'Veterans Health Administration, Screening for lung cancer pamphlet. 2020. http://www.prevention.va.gov/docs/LungCancerScreeningHandout.pdf. Accessed June 20, 2024.'}, {'pmid': '30625501', 'type': 'BACKGROUND', 'citation': 'Dharod A, Bellinger C, Foley K, Case LD, Miller D. The Reach and Feasibility of an Interactive Lung Cancer Screening Decision Aid Delivered by Patient Portal. Appl Clin Inform. 2019 Jan;10(1):19-27. doi: 10.1055/s-0038-1676807. Epub 2019 Jan 9.'}, {'pmid': '15343421', 'type': 'BACKGROUND', 'citation': 'Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94.'}, {'pmid': '14715214', 'type': 'BACKGROUND', '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.'}, {'pmid': '25157591', 'type': 'BACKGROUND', 'citation': 'Carter-Harris L, Hall LA. Development of a short version of the Cataldo Lung Cancer Stigma Scale. J Psychosoc Oncol. 2014;32(6):665-77. doi: 10.1080/07347332.2014.955238.'}, {'pmid': '11217186', 'type': 'BACKGROUND', '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.'}, {'pmid': '27244666', 'type': 'BACKGROUND', '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.'}, {'pmid': '22013026', 'type': 'BACKGROUND', 'citation': 'Williams DR, Yan Yu, Jackson JS, Anderson NB. Racial Differences in Physical and Mental Health: Socio-economic Status, Stress and Discrimination. J Health Psychol. 1997 Jul;2(3):335-51. doi: 10.1177/135910539700200305.'}, {'type': 'BACKGROUND', 'citation': 'Weinstein D. The Precaution Adoption Process Model. In: Glanz K, Rimer BK, Viswanath K, eds. Health behavior and health education: Theory, research, and practice, 4th ed. 4th ed. San Francisco, CA, US: Jossey-Bass; 2008:xxxiii-552, pp. 123-147.'}]}, 'descriptionModule': {'briefSummary': 'This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 50 years to 80 years\n* Currently smoke cigarettes or quit smoking cigarettes within the past 15 years\n* 20 pack-year smoking history\n* Has never had lung cancer screening\n* Able to provide informed consent\n* Able to speak and understand English\n\nExclusion Criteria:\n\n* Diagnosed with lung cancer\n* Has a history of having a lung cancer screening scan\n* Unable to speak and understand English'}, 'identificationModule': {'nctId': 'NCT06605534', 'briefTitle': 'Leveraging the Emergency Department (LEAD) Study', 'organization': {'class': 'OTHER', 'fullName': 'Hackensack Meridian Health'}, 'officialTitle': 'LEAD Pilot Study: Leveraging the Emergency Department to Address SDOH and Reduce Lung Cancer Screening Disparities', 'orgStudyIdInfo': {'id': 'Pro2024-0236'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LungTalk Group', 'description': '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 Lung Cancer Screening (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% CI, 1.03, 3.85, p = 0.03.', 'interventionNames': ['Behavioral: LungTalk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-tailored Lung Screening Pamphlet Group', 'description': 'Non-tailored Lung Screening Pamphlet is a non-tailored educational brochure, What is Lung Cancer Screening from the GO2 Foundation that will be emailed to the patient. This widely used educational standard of care is a 2-page reader-friendly non-tailored electronic brochure about risk and screening for lung cancer used in clinical and community settings.', 'interventionNames': ['Other: Non-tailored lung screening']}], 'interventions': [{'name': 'LungTalk', 'type': 'BEHAVIORAL', 'description': 'Tailored lung screening intervention', 'armGroupLabels': ['LungTalk Group']}, {'name': 'Non-tailored lung screening', 'type': 'OTHER', 'description': 'Non-tailored lung screening. It involves the addition of education to Social Determinants of Health (SDOH) screening and referral with patient navigation. Patients will be identified, and screened for SDOH needs using the UniteUs SDOH screener that is embedded in the Electronic Health Record (EHR), and connected to geographically-tailored resources (as described above under Arm 1). Participants will then be sent a non-tailored lung screening educational brochure via email to review that details lung cancer risk, lung screening facts, benefits, and potential harms. Within 48 hours, the Community Outreach and Engagement (COE) Patient Navigator will contact the patient to answer questions and provide navigation services as described above in Arm 1.', 'armGroupLabels': ['Non-tailored Lung Screening Pamphlet Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08724', 'city': 'Brick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Ocean Medical Center', 'geoPoint': {'lat': 40.05928, 'lon': -74.13708}}, {'zip': '08820', 'city': 'Edison', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'John F. Kennedy Medical Center', 'geoPoint': {'lat': 40.51872, 'lon': -74.4121}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '07733', 'city': 'Holmdel', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Bayshore Medical Center', 'geoPoint': {'lat': 40.34511, 'lon': -74.18403}}, {'zip': '08050', 'city': 'Manahawkin', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Southern Ocean Medical Center', 'geoPoint': {'lat': 39.6954, 'lon': -74.25875}}, {'zip': '07753', 'city': 'Neptune City', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Jersey Shore University Medical Center', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '07047', 'city': 'North Bergen', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Palisades Medical Center', 'geoPoint': {'lat': 40.80427, 'lon': -74.01208}}, {'zip': '08857', 'city': 'Old Bridge', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Old Bridge Medical Center', 'geoPoint': {'lat': 40.41483, 'lon': -74.36543}}, {'zip': '08861', 'city': 'Perth Amboy', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Raritan Bay Medical Center', 'geoPoint': {'lat': 40.50677, 'lon': -74.26542}}, {'zip': '07701', 'city': 'Red Bank', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gia Nealy', 'role': 'CONTACT', 'email': 'gia.nealy@hmh-cdi.org', 'phone': '201-880-3564'}], 'facility': 'Riverview Medical Center', 'geoPoint': {'lat': 40.34705, 'lon': -74.06431}}], 'centralContacts': [{'name': 'Ana Guadalupe Vielma, PhD', 'role': 'CONTACT', 'email': 'ana.vielma@hmh-cdi.org', 'phone': '2018803400'}, {'name': 'Francis Valenzona', 'role': 'CONTACT', 'email': 'francis.valenzona@hmh-cdi.org', 'phone': '2018803400'}], 'overallOfficials': [{'name': 'Lisa Carter-Bawa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hackensack Meridian Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hackensack Meridian Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'New Jersey Commission on Cancer Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}