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| Name | Class |
|---|---|
| New Jersey Commission on Cancer Research | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LungTalk Group | Experimental | 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. |
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| Non-tailored Lung Screening Pamphlet Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LungTalk | Behavioral | Tailored lung screening intervention |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Cancer Screening Uptake | Completion of a Screening Low-Dose Computed Tomography (LDCT) of the Chest confirmed via Electronic Health Records (EHR)) | Assessed at 1 month and 6 months post intervention |
| Stage of Adoption for Lung Cancer Screening | 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. | Assessed at 1 week and then at 1 month and 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Health Literacy Scale | 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. |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana Guadalupe Vielma, PhD | Contact | 2018803400 | ana.vielma@hmh-cdi.org | |
| Francis Valenzona | Contact | 2018803400 | francis.valenzona@hmh-cdi.org |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Carter-Bawa, PhD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ocean Medical Center | Recruiting | Brick | New Jersey | 08724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33532112 | Background | 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. | |
| Background | Cancer Facts & Figures for African Americans 2019-2021. In: American Cancer Society. Atlanta: 2019. | ||
| Background | 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. | ||
| 33000953 |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Non-tailored lung screening |
| Other |
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. |
|
| At one week and one month post intervention |
| Medical Mistrust Scale | 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. | At one week and one month post intervention |
| Perceived Stigma Scale | 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. | At one week and one month post intervention |
| Perceived Risk of Lung Cancer Scale | 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. | At one week and one month post intervention |
| Perceived Benefits of Lung Cancer Screening Scale | 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 | At one week and one month post intervention |
| Perceived Barriers to Lung Cancer Screening Scale | 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 | At one week and one month post intervention |
| Self-Efficacy for Lung Cancer Screening Scale | 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. | At one week and one month post intervention |
| Knowledge: Lung Cancer and Screening Scale | 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. | At one week and one month post intervention |
| Lung Cancer Fatalism | 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. | At one week and one month post intervention |
| John F. Kennedy Medical Center | Recruiting | Edison | New Jersey | 08820 | United States |
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| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
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| Bayshore Medical Center | Recruiting | Holmdel | New Jersey | 07733 | United States |
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| Southern Ocean Medical Center | Recruiting | Manahawkin | New Jersey | 08050 | United States |
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| Jersey Shore University Medical Center | Recruiting | Neptune City | New Jersey | 07753 | United States |
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| Palisades Medical Center | Recruiting | North Bergen | New Jersey | 07047 | United States |
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| Old Bridge Medical Center | Recruiting | Old Bridge | New Jersey | 08857 | United States |
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| Raritan Bay Medical Center | Recruiting | Perth Amboy | New Jersey | 08861 | United States |
|
| Riverview Medical Center | Recruiting | Red Bank | New Jersey | 07701 | United States |
|
| Background |
| 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. |
| 27241830 | Background | 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. |
| Background | American Lung Association: State of Lung Cancer. In. Chicago, IL: American Lung Association; 2019. |
| 21714641 | Background | 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. |
| Background | 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. |
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| Background | 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |