Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 7R01CA263662-02 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
Not provided
Not provided
Not provided
Not provided
LungTalk and leveraging Facebook-targeted Advertisement (FBTA) addresses the call to develop and test multi-level, cancer communication interventions using innovative methods and designs. The study's long term goal is to increase lung cancer screening uptake among appropriate, high-risk individuals nationwide.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored health communication intervention (LungTalk) | Experimental | 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. |
|
| Non-tailored Intervention | Active Comparator | Participants will receive non-tailored American Cancer Society (ACS) Lung Screening Informational Video as per standard of care. ACS Lung Screening Informational Video (ACS LSIV) is a non-tailored 5-minute video from the American Cancer Society about lung cancer screening designed for the lay individual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LungTalk | Behavioral | LungTalk is a 10-15 minute long computer-tailored health communication and decision-making tool. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reaching Screening Eligible Individuals Via Social Media - Reach | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of people who saw the FBTA at least once. | 11-month period ad remained active on Facebook |
| Reaching Screening Eligible Individuals Via Social Media - Link Clicks | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of clicks on the link within the FBTA that led to the REDCap survey platform of the study. | 11-month period ad remained active on Facebook |
| Reaching Screening Eligible Individuals Via Social Media - Impressions | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of times the FBTA was on screen (may include multiple views of the ad by the same person/people). | 11-month period ad remained active on Facebook |
| Effectiveness of LungTalk - Knowledge Assessment | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being "No Knowledge" and 9 being "Complete knowledge". | At baseline |
| Effectiveness of LungTalk - Knowledge Assessment | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being "No Knowledge" and 9 being "Complete knowledge". |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | Final recommendation statement: Lung cancer screening. U. S. Preventive Services Task Force. Updated March 9, 2021. Accessed May 26, 2021, 2021. https://www.uspreventiveservicestaskforce.org/uspstf/document/RecommendationStatementFinal/lung-cancer-screening | ||
| Background | United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening. Updated Updated December 2016. Accessed May 21, 2020. http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/lung-cancer-screening | ||
| 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 | De Koning H. ES 02.01 The Dutch-Belgian Lung Cancer Screening Trial (NELSON). Journal of Thoracic Oncology. 2017;12(11):S1611. doi:10.1016/j.jtho.2017.09.108 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
We initially had 512 participants enroll in the study. Still, only 483 were randomized to the study arms, as the remaining 29 participants were lost to follow-up after failing to complete the baseline survey upon enrollment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Tailored Health Communication Intervention (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 | Non-tailored Intervention | Participants will receive non-tailored American Cancer Society (ACS) Lung Screening Informational Video as per standard of care. ACS Lung Screening Informational Video (ACS LSIV) is a non-tailored 5-minute video from the American Cancer Society about lung cancer screening designed for the lay individual. Non-tailored intervention - Standard of practice: ACS Lung Screening Informational Video |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Results are reported in aggregate because the baseline characteristics were collected prior to randomization, and there were no arm-specific differences at this stage.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Consented Patients to the Study | Results are reported in aggregate because the baseline characteristics were collected prior to randomization, and there were no arm-specific differences at this stage. |
| 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 | Reaching Screening Eligible Individuals Via Social Media - Reach | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of people who saw the FBTA at least once. | Facebook-provided metrics were collected at the aggregate level (impressions, reach, engagements, and clicks). Because individual-level identifiers were not captured, it is not possible to report a precise 'number of people analyzed' from the platform; therefore, all Facebook-derived outcomes are reported as aggregate counts and rates. The total reach number on FB which is 3,109,482 is used instead. | Posted | Number | participants | 11-month period ad remained active on Facebook |
|
6 months post-enrolment for all participants who completed the baseline survey
Any adverse events reported
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tailored Health Communication Intervention (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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana Vielma | Hackensack Meridian Health - Center for Discovery and Innovation | 2018803100 | ana.vielma@hmh-cdi.org |
Not provided
| 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 | Apr 20, 2023 | Sep 5, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Non-tailored intervention - Standard of practice | Behavioral | ACS Lung Screening Informational Video |
|
| At one week from baseline survey completion |
| Effectiveness of LungTalk - Perceived Risk | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer). | At baseline |
| Effectiveness of LungTalk - Perceived Risk | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer). | At one week from baseline survey completion |
| Effectiveness of LungTalk - Perceived Benefits | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is 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). | At baseline |
| Effectiveness of LungTalk - Perceived Benefits | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is 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). | At one week from baseline survey completion |
| Effectiveness of LungTalk - Perceived Barriers | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. 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). | At baseline |
| Effectiveness of LungTalk - Perceived Barriers | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. 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). | At one week from baseline survey completion |
| Effectiveness of LungTalk - Self-Efficacy | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy). | At baseline |
| Effectiveness of LungTalk - Self-Efficacy | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy). | At one week from baseline survey completion |
| Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | At baseline |
| Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | At one week from baseline survey completion |
| Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | At 6 months from baseline survey completion |
| Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | At baseline |
| Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | At one week from baseline survey completion |
| Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | At 6 months from baseline survey completion |
| Background | Centers for Medicare & Medicaid Services. Decision memo for screening for lung cancer with low-dose computed tomography (LDCT) (CAG-00439N). Accessed May 21, 2020. https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274 |
| 31019776 | Background | Okereke IC, Nishi S, Zhou J, Goodwin JS. Trends in lung cancer screening in the United States, 2016-2017. J Thorac Dis. 2019 Mar;11(3):873-881. doi: 10.21037/jtd.2019.01.105. |
| 26701339 | 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. |
| 29552458 | Background | 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. |
| 29146565 | Background | 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. |
| 24088228 | Background | Chambers DA, Glasgow RE, Stange KC. The dynamic sustainability framework: addressing the paradox of sustainment amid ongoing change. Implement Sci. 2013 Oct 2;8:117. doi: 10.1186/1748-5908-8-117. |
| Background | United States Preventive Services Task Force. Final recommendation statement: Lung cancer screening. Accessed October 10. http://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/lung-cancer-screening |
| Background | United States Preventive Services Task Force. Draft recommendation statement: lung cancer: Screening July 7, 2020. Accessed October 10. https://uspreventiveservicestaskforce.org/uspstf/draft-recommendation/lung-cancer-screening-2020 |
| 33141096 | Background | 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. |
| 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. |
| 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. |
| 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. |
| 27306780 | Background | Carter-Harris L, Bartlett Ellis R, Warrick A, Rawl S. Beyond Traditional Newspaper Advertisement: Leveraging Facebook-Targeted Advertisement to Recruit Long-Term Smokers for Research. J Med Internet Res. 2016 Jun 15;18(6):e117. doi: 10.2196/jmir.5502. |
| Background | Facebook Distribution of Users by Age Group in the U.S. Facebook. Accessed May 26, 2021, 2021. https://www.statista.com/statistics/187549/facebook-distribution-of-users-age-group-usa/ |
| 24127266 | Background | Frandsen M, Walters J, Ferguson SG. Exploring the viability of using online social media advertising as a recruitment method for smoking cessation clinical trials. Nicotine Tob Res. 2014 Feb;16(2):247-51. doi: 10.1093/ntr/ntt157. Epub 2013 Oct 14. |
| 22360969 | Background | Ramo DE, Prochaska JJ. Broad reach and targeted recruitment using Facebook for an online survey of young adult substance use. J Med Internet Res. 2012 Feb 23;14(1):e28. doi: 10.2196/jmir.1878. |
| 20530194 | Background | Ramo DE, Hall SM, Prochaska JJ. Reaching young adult smokers through the internet: comparison of three recruitment mechanisms. Nicotine Tob Res. 2010 Jul;12(7):768-75. doi: 10.1093/ntr/ntq086. Epub 2010 Jun 7. |
| 24090626 | Background | Ramo DE, Delucchi KL, Liu H, Hall SM, Prochaska JJ. Young adults who smoke cigarettes and marijuana: analysis of thoughts and behaviors. Addict Behav. 2014 Jan;39(1):77-84. doi: 10.1016/j.addbeh.2013.08.035. Epub 2013 Sep 7. |
| Background | Smith A, Anderson M. Social media use in 2018. Pew Internet.org. Updated October 9. https://www.pewinternet.org/2018/03/01/social-media-use-in-2018/ |
| Background | United States Adults Social Platform Use. Social networking platforms' demographics update 2019. Marketingcharts.com,. Accessed October 9, https://www.marketingcharts.com/charts/us-adults-social-platform-use-demographic-group-2019/attachment/pew-social-platform-use-by-demographic-apr2019 |
| 19376676 | Background | 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. |
| 20558196 | Background | 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. |
| 17592961 | Background | Noar SM, Benac CN, Harris MS. Does tailoring matter? Meta-analytic review of tailored print health behavior change interventions. Psychol Bull. 2007 Jul;133(4):673-93. doi: 10.1037/0033-2909.133.4.673. |
| Background | Kreuter M, Farrell D, Olevitch L, Brennan L. Tailoring health messages: Customizing communication with computer technology. Tailoring health messages: Customizing communication with computer technology. Lawrence Erlbaum Associates Publishers; 2000:xiii, 270-xiii, 270. |
| 22926008 | Background | 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. |
| 17689600 | Background | 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. |
| 24621965 | Background | Wu TY, Lin C. Developing and evaluating an individually tailored intervention to increase mammography adherence among Chinese American women. Cancer Nurs. 2015 Jan-Feb;38(1):40-9. doi: 10.1097/NCC.0000000000000126. |
| 15550305 | Background | 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. |
| 9341350 | Background | 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. |
| 25532218 | Background | 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. |
| Background | Memorial Sloan Kettering Cancer Center. Memorial Sloan Kettering Cancer Center, Lung cancer screening decision tool. Accessibility verified February 12, 2016. Accessed October 7, 2020. http://nomograms.mskcc.org/Lung/Screening.aspx |
| Background | Chen Y, Marcus MW, Niaz A, Duffy SW, Field JK. 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. 2014/05/04 2014;52(3):144-152. doi:10.1080/14635240.2014.888814 |
| 24518006 | Background | 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. |
| Background | Veterans Health Administration. Veterans Health Administration, Screening for lung cancer pamphlet. Accessibility verified February 12, 2016. Accessed September 29,. http://www.prevention.va.gov/docs/LungCancerScreeningHandout.pdf. |
| 30625501 | Background | 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. |
| 28304262 | Background | 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. |
| 29473696 | Background | McDonnell KK, Strayer SM, Sercy E, Campbell C, Friedman DB, Cartmell KB, Eberth JM. Developing and testing a brief clinic-based lung cancer screening decision aid for primary care settings. Health Expect. 2018 Aug;21(4):796-804. doi: 10.1111/hex.12675. Epub 2018 Feb 23. |
| Background | American Cancer Society. Cancer Screening Tests Videos. Accessed October 9. https://www.cancer.org/healthy/find-cancer-early/cancer-screening-tests-videos.html |
| Background | American Cancer Society. Lung Cancer Screening Guidelines. Accessed October 9. https://www.cancer.org/health-care-professionals/american-cancer-society-prevention-early-detection-guidelines/lung-cancer-screening-guidelines.html |
| Background | FACEBOOK for developers. Facebook Analytics Accessed October 9, 2020. https://developers.facebook.com/docs/analytics/ |
| 10474547 | Background | Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322. |
| 31789598 | Background | Russomanno J, Patterson JG, Jabson Tree JM. Social Media Recruitment of Marginalized, Hard-to-Reach Populations: Development of Recruitment and Monitoring Guidelines. JMIR Public Health Surveill. 2019 Dec 2;5(4):e14886. doi: 10.2196/14886. |
| Background | GO2 Foundation. Screening Centers of Excellence citation. Accessed October 9, 2020, (https://go2foundation.org/risk-early-detection/screening-centers/) |
| Background | Raudenbush Stephen W, Bryk Anthony S, eds. Hierarchical Linear Models: Applications and Data Analysis Methods. 2 ed. SAGE Publications, Inc.; 2002. |
| Background | Graham JW, Hofer SM, Donaldson SI, MacKinnon DP, Schafer JL. Analysis with missing data in prevention research. In: Bryant K, Windle M, West S, eds. The science of prevention: methodological advances from alcohol and substance abuse research. American Psychological Association; 1997:325-366. |
| 26753828 | Background | Schafer JL, Olsen MK. Multiple Imputation for Multivariate Missing-Data Problems: A Data Analyst's Perspective. Multivariate Behav Res. 1998 Oct 1;33(4):545-71. doi: 10.1207/s15327906mbr3304_5. |
| Background | Hedeker D, Gibbons RD. Application of random-effects pattern-mixture models for missing data in longitudinal studies. Psychological Methods. 1997;2(1):64-78. doi:10.1037/1082-989X.2.1.64 |
| Background | Benjamini Y, Hochberg Y. On the Adaptive Control of the False Discovery Rate in Multiple Testing With Independent Statistics. Journal of Educational and Behavioral Statistics. 2000;25(1):60-83. doi:10.3102/10769986025001060 |
| 29942634 | Background | Arigo D, Pagoto S, Carter-Harris L, Lillie SE, Nebeker C. Using social media for health research: Methodological and ethical considerations for recruitment and intervention delivery. Digit Health. 2018 May 7;4:2055207618771757. doi: 10.1177/2055207618771757. eCollection 2018 Jan-Dec. |
| 37237339 | Derived | Carter-Bawa L, Banerjee SC, Comer RS, Kale MS, King JC, Leopold KT, Monahan PO, Ostroff JS, Slaven JE Jr, Valenzona F, Wiener RS, Rawl SM. Leveraging social media to increase lung cancer screening awareness, knowledge and uptake among high-risk populations (The INSPIRE-Lung Study): study protocol of design and methods of a community-based randomized controlled trial. BMC Public Health. 2023 May 26;23(1):975. doi: 10.1186/s12889-023-15857-8. |
| 37205569 | Derived | Lisa CB, Banerjee SC, Ostroff JS, Kale MS, King JC, Leopold KT, Monahan PO, Slaven JE Jr, Wiener RS, Valenzona F, Rawl SM, Comer RS. Leveraging social media to increase lung cancer screening awareness, knowledge and uptake among high-risk populations (The INSPIRE-Lung Study): Study protocol of design and methods of a community-based randomized controlled trial. Res Sq [Preprint]. 2023 May 4:rs.3.rs-2846041. doi: 10.21203/rs.3.rs-2846041/v1. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Reaching Screening Eligible Individuals Via Social Media - Link Clicks | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of clicks on the link within the FBTA that led to the REDCap survey platform of the study. | Overall Number of Participants Analyzed represents the number of participants screened for study interest prior to enrollment | Posted | Number | unique clicks | 11-month period ad remained active on Facebook |
|
|
|
| Primary | Reaching Screening Eligible Individuals Via Social Media - Impressions | Leveraging a well-established, social media-based platform (Facebook) to target screening-eligible individuals in the community. This will be measured by the total number of times the FBTA was on screen (may include multiple views of the ad by the same person/people). | Facebook-provided metrics were collected at the aggregate level (impressions, reach, engagements, and clicks). Because individual-level identifiers were not captured, it is not possible to report a precise 'number of people analyzed' from the platform; therefore, all Facebook-derived outcomes are reported as aggregate counts and rates. The total reach number on FB which is 3,109,482 is used instead. | Posted | Number | number of times the add was viewed | 11-month period ad remained active on Facebook |
|
|
|
| Primary | Effectiveness of LungTalk - Knowledge Assessment | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being "No Knowledge" and 9 being "Complete knowledge". | Posted | Mean | Full Range | score on a scale | At baseline |
|
|
|
| Primary | Effectiveness of LungTalk - Knowledge Assessment | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve total knowledge about lung screening. The total Knowledge of Lung Cancer Screening will be assessed with a 9-item multidimensional scale ranging from 0 to 9 with 0 being "No Knowledge" and 9 being "Complete knowledge". | Posted | Mean | Full Range | score on a scale | At one week from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Perceived Risk | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer). | Posted | Mean | Full Range | score on a scale | At baseline |
|
|
|
| Primary | Effectiveness of LungTalk - Perceived Risk | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Risk. Perceived Risk of Lung Cancer is a 3-item scale with Likert-type responses. The range of scores is 3 to 12 (higher perceived risk of lung cancer). | Posted | Mean | Full Range | score on a scale | At one week from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Perceived Benefits | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is 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). | Posted | Mean | Full Range | score on a scale | At baseline |
|
|
|
| Primary | Effectiveness of LungTalk - Perceived Benefits | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Benefits. Perceived Benefits of Lung Cancer Screening is 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). | Posted | Mean | Full Range | score on a scale | At one week from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Perceived Barriers | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. 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). | Posted | Mean | Full Range | score on a scale | At baseline |
|
|
|
| Primary | Effectiveness of LungTalk - Perceived Barriers | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Perceived Barriers. 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). | Posted | Mean | Full Range | score on a scale | At one week from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Self-Efficacy | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy). | Posted | Mean | Full Range | score on a scale | At baseline |
|
|
|
| Primary | Effectiveness of LungTalk - Self-Efficacy | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Self-Efficacy. Self-Efficacy for Lung Cancer Screening will be assessed using a scale with nine items with a four-point Likert response option to assess individual beliefs about ability to arrange and complete a low-dose computed tomography (LDCT) to screen for lung cancer. The range of scores is 9 to 36 (higher levels of self-efficacy). | Posted | Mean | Full Range | score on a scale | At one week from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | The number of participants who reported having discussed with their health care provider regarding lung screening at any time prior to their enrollment. | Posted | Count of Participants | Participants | At baseline |
|
|
|
| Primary | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | The number of participants who reported having discussed with their health care provider regarding lung screening since viewing the program. | Posted | Count of Participants | Participants | At one week from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Occurrence of a Patient-Clinician Discussion | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Occurrence of a Patient-Clinician Discussion. Occurrence of a Patient-Clinician Discussion about Lung Cancer Screening will be assessed with a single item requiring dichotomous (Y/N) response regarding a discussion with their healthcare provider. | The number of participants who discussed with their health care provider about lung screening since viewing the program, captured at 6 months post survey completion. | Posted | Count of Participants | Participants | At 6 months from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | The number of participants who had a lung scan (low dose CAT scan) to screen for lung cancer prior to their enrolment. | Posted | Count of Participants | Participants | At baseline |
|
|
|
| Primary | Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | 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 week post survey completion). | Posted | Count of Participants | Participants | At one week from baseline survey completion |
|
|
|
| Primary | Effectiveness of LungTalk - Screening Uptake | The assessment plan is intended to compare the effectiveness of a tailored (LungTalk) versus non-tailored health communication and decision support tool delivered online to improve Screening Uptake, Lung Cancer Screening Uptake will be assessed via self-report via the stages of adoption algorithm for lung screening. There are seven stages (unaware, aware but unengaged, undecided, decided not to act, decided to act, action, and maintenance). | The number of participants who had a lung scan (low dose CAT scan) to screen for lung cancer since joining this study (captured at 6 months post baseline survey completion). | Posted | Count of Participants | Participants | At 6 months from baseline survey completion |
|
|
|
| 0 |
| 240 |
| 0 |
| 240 |
| 0 |
| 240 |
| EG001 | Non-tailored Intervention | Participants will receive non-tailored American Cancer Society (ACS) Lung Screening Informational Video as per standard of care. ACS Lung Screening Informational Video (ACS LSIV) is a non-tailored 5-minute video from the American Cancer Society about lung cancer screening designed for the lay individual. Non-tailored intervention - Standard of practice: ACS Lung Screening Informational Video | 0 | 243 | 0 | 243 | 0 | 243 |
Not provided
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |