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| Name | Class |
|---|---|
| Becton, Dickinson and Company | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social determinants of health screening | Experimental | Participants will receive a social determinants of health screening assessment and referral process in addition to the community-based lung cancer screening educational tool. |
|
| Community-based lung cancer screening | Active Comparator | Participants will receive a community-based lung cancer screening educational tool. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Health Literacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Carter-Bawa, PhD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack Meridian Health - Center for Discovery and Innovation | Nutley | New Jersey | 07110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 36205665 | Background | 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. | |
| 26701339 |
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We initially had 101 participants enroll in the study. Only 97 were randomized to the study arms, as the remaining 4 participants were lost to follow-up after failing to complete the baseline survey upon enrollment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Community-based Lung Cancer Screening (LungTalk) | Participants will receive the tailored health intervention "LungTalk". LungTalk is a 10-15-minute-long computer-tailored health communication and decision-making tool that is theoretically grounded in the Conceptual Model on Lung Cancer Screening Participation. LungTalk: LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool. |
| FG001 | Social Determinants of Health Screening (LungTalk + SDoH) | Participants will receive a social determinants of health screening (SDoH) assessment and referral process in addition to the community-based lung cancer screening educational tool, "LungTalk". |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Community-based Lung Cancer Screening (LungTalk) | Participants will receive the tailored health intervention "LungTalk". LungTalk is a 10-15-minute-long computer-tailored health communication and decision-making tool that is theoretically grounded in the Conceptual Model on Lung Cancer Screening Participation. LungTalk: LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lung Cancer Screening Uptake | Number of participants in the two groups that get screened (have a computed tomography (CT or CAT) scan) | The number of participants who had a lung scan (low dose CAT scan) to screen for lung cancer since joining this study (captured at 1 month post survey completion). | Posted | Count of Participants | Participants | 1 months post intervention |
|
1 month post-enrollment for all participants who completed the baseline survey
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Community-based Lung Cancer Screening (LungTalk) | Participants will receive the tailored health intervention "LungTalk". LungTalk is a 10-15-minute-long computer-tailored health communication and decision-making tool that is theoretically grounded in the Conceptual Model on Lung Cancer Screening Participation. LungTalk: LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ana Guadalupe Vielma | Hackensack Meridian Health - Center for Discovery and Innovation | 2018803100 | ana.vielma@hmh-cdi.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 7, 2024 | Jan 27, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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. |
|
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) | Baseline |
| 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) | 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) | 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) | Baseline |
| 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). | 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). | 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). | 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). | 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". | 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". | 1 months post intervention |
| Background |
| 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. |
| 28122849 | Background | 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. |
| 31550991 | Background | 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. |
| 32556187 | Background | 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. |
| Background | Weinstein D. The Precaution Adoption Process Model. In: Health Behavior and Health Education: Theory, Researchm and Practice. 4th Ed. Jossey-Bass; 2008:123-147. |
| 15343421 | Background | Chew LD, Bradley KA, Boyko EJ. Brief questions to identify patients with inadequate health literacy. Fam Med. 2004 Sep;36(8):588-94. |
| 14715214 | Background | 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. |
| 21186151 | Background | 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. |
| 11217186 | Background | 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. |
| 27244666 | Background | 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. |
| 31078660 | Background | 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. |
| BG001 | Social Determinants of Health Screening (LungTalk + SDoH) | Participants will receive a social determinants of health screening (SDoH) assessment and referral process in addition to the community-based lung cancer screening educational tool, "LungTalk". |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| Social Determinants of Health Screening (LungTalk + SDoH) |
Participants will receive a social determinants of health screening (SDoH) assessment and referral process in addition to the community-based lung cancer screening educational tool, "LungTalk". |
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
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|
| Secondary | 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) | The analysis population comprises 76 participants who responded at 1 month post-intervention. | Posted | Median | Inter-Quartile Range | score on a scale | 1 months post intervention |
|
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| Secondary | Medical Mistrust | Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust) | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
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| Secondary | Medical Mistrust | Medical Mistrust will be measured with 5 items ranging from 5 (low mistrust) to 25 (high mistrust) | The analysis population comprises 76 participants who responded at 1 month post-intervention. | Posted | Median | Inter-Quartile Range | score on a scale | 1 months post intervention |
|
|
|
| Secondary | 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) | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Secondary | 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) | The analysis population comprises 76 participants who responded at 1 month post-intervention. | Posted | Median | Inter-Quartile Range | score on a scale | 1 months post intervention |
|
|
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| Secondary | Lung Cancer Fatalism | Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism) | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
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|
| Secondary | Lung Cancer Fatalism | Lung Cancer Fatalism will be measured with 11 items ranging from 0 (no fatalism) to 11 (high fatalism) | The analysis population comprises 76 participants who responded at 1 month post-intervention. | Posted | Median | Inter-Quartile Range | score on a scale | 1 months post intervention |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Secondary | 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). | The analysis population comprises 97 participants who responded to this scale at 1 month post-intervention. | Posted | Median | Inter-Quartile Range | score on a scale | 1 months post intervention |
|
|
|
| Secondary | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Baseline |
|
|
|
| Secondary | 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). | The analysis population comprises 76 participants who responded at 1 month post-intervention. | Posted | Median | Inter-Quartile Range | score on a scale | 1 months post intervention |
|
|
|
| Secondary | 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". | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | 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". | The analysis population comprises 76 participants who responded at 1 month post-intervention. | Posted | Count of Participants | Participants | 1 months post intervention |
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| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Social Determinants of Health Screening (LungTalk + SDoH) | Participants will receive a social determinants of health screening (SDoH) assessment and referral process in addition to the community-based lung cancer screening educational tool, "LungTalk". | 0 | 51 | 0 | 51 | 0 | 51 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |