NCT04683744|CompletedResults
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Patient-Centered Outcomes Research Institute
observational
82
1 country
1
Study Start
January 11, 2021
Actual (reported)Primary Completion
May 3, 2023
Actual (reported)Study Completion
July 31, 2023
Actual (reported)The rate of screening for colorectal cancer (CRC) in the U.S. remains low (under 65%), meaning that thousands of people die of colorectal cancer unnecessarily. Colorectal cancer screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). Screening rates go up when patients consider all these tests, not just colonoscopy. Informing patients about their options for CRC screening could produce higher quality decisions, improve the match between patient preferences and tests performed, and increase uptake of CRC screening. Decision aids (DAs) are a promising tool for accomplishing this goal. Also, precision CRC prevention - providing information about an individual's specific risk for CRC - has great promise to increase uptake and improve decision making. Unfortunately, the COVID-19 pandemic is causing severe challenges to providing CRC screening and other prevention services. Health systems are trying to adapt, but these efforts have only begun and are poorly understood. Moreover, patient perceptions of disease risk and risk from COVID-19 are unknown.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 20, 2020
Actual (reported)December 24, 2020
Actual (reported)January 11, 2021
Actual (reported)May 3, 2023
Actual (reported)July 31, 2023
Actual (reported)January 31, 2025
Actual (reported)Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.
Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening.
2 years
Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff.
Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening.
9 months
Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.
Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making.
Leadership, providers, and staff at the study team's affiliated health systems.
Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems.
The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
The participants will be health system primary care patients, and health system leadership, providers, or staff involved in primary care.
Indiana University
Indianapolis, Indiana, 462020, United States
Kaufman HW, Chen Z, Niles J, Fesko Y. Changes in the Number of US Patients With Newly Identified Cancer Before and During the Coronavirus Disease 2019 (COVID-19) Pandemic. JAMA Netw Open. 2020 Aug 3;3(8):e2017267. doi: 10.1001/jamanetworkopen.2020.17267.
Castanon A, Rebolj M, Pesola F, Sasieni P. Recovery strategies following COVID-19 disruption to cervical cancer screening and their impact on excess diagnoses. Br J Cancer. 2021 Apr;124(8):1361-1365. doi: 10.1038/s41416-021-01275-3. Epub 2021 Feb 9.
We involved just two healthcare systems in one Midwestern city. Our sample of interviewed leaders, providers, and staff may not have been representative of the entire organizations. Our method for identifying patients to interview did not include all patients at these health systems who were due for screening early in the pandemic, so we may have failed to include important perspectives or experiences.
Peter Schwartz, MD, PhD
Indiana University
82 participants (actual enrollment reported by the registry).
First Submitted
December 20, 2020
First Posted
December 24, 2020
Study Start
January 11, 2021
Actual (reported)Test Up Now Education Program
6 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Chen RC, Haynes K, Du S, Barron J, Katz AJ. Association of Cancer Screening Deficit in the United States With the COVID-19 Pandemic. JAMA Oncol. 2021 Jun 1;7(6):878-884. doi: 10.1001/jamaoncol.2021.0884.
Alkatout I, Biebl M, Momenimovahed Z, Giovannucci E, Hadavandsiri F, Salehiniya H, Allahqoli L. Has COVID-19 Affected Cancer Screening Programs? A Systematic Review. Front Oncol. 2021 May 17;11:675038. doi: 10.3389/fonc.2021.675038. eCollection 2021.
Czeisler ME, Marynak K, Clarke KEN, Salah Z, Shakya I, Thierry JM, Ali N, McMillan H, Wiley JF, Weaver MD, Czeisler CA, Rajaratnam SMW, Howard ME. Delay or Avoidance of Medical Care Because of COVID-19-Related Concerns - United States, June 2020. MMWR Morb Mortal Wkly Rep. 2020 Sep 11;69(36):1250-1257. doi: 10.15585/mmwr.mm6936a4.
Findling MG, Blendon RJ, Benson JM. Delayed Care with Harmful Health Consequences-Reported Experiences from National Surveys During Coronavirus Disease 2019. JAMA Health Forum. 2020 Dec 1;1(12):e201463. doi: 10.1001/jamahealthforum.2020.1463. No abstract available.
Park S, Stimpson JP. Trends in Self-reported Forgone Medical Care Among Medicare Beneficiaries During the COVID-19 Pandemic. JAMA Health Forum. 2021 Dec 30;2(12):e214299. doi: 10.1001/jamahealthforum.2021.4299. eCollection 2021 Dec.
Lieneck C, Herzog B, Krips R. Analysis of Facilitators and Barriers to the Delivery of Routine Care during the COVID-19 Global Pandemic: A Systematic Review. Healthcare (Basel). 2021 May 1;9(5):528. doi: 10.3390/healthcare9050528.
Aitken M, Kleinrock M. Shifts in Healthcare Demand, Delivery and Care During the COVID-19 Era. Published online 2020. https://www.iqvia.com/insights/the-iqvia-institute/covid-19/shifts-in-healthcare-demand-delivery-and-care-during-the-covid-19-era
Powell RE, Henstenburg JM, Cooper G, Hollander JE, Rising KL. Patient Perceptions of Telehealth Primary Care Video Visits. Ann Fam Med. 2017 May;15(3):225-229. doi: 10.1370/afm.2095.
Price ST, Mainous AG, Rooks BJ. Survey of cancer screening practices and telehealth services among primary care physicians during the COVID-19 pandemic. Prev Med Rep. 2022 Mar 17;27:101769. doi: 10.1016/j.pmedr.2022.101769. eCollection 2022 Jun.
Basu P, Alhomoud S, Taghavi K, Carvalho AL, Lucas E, Baussano I. Cancer Screening in the Coronavirus Pandemic Era: Adjusting to a New Situation. JCO Glob Oncol. 2021 Mar;7:416-424. doi: 10.1200/GO.21.00033.
Cancino RS, Su Z, Mesa R, Tomlinson GE, Wang J. The Impact of COVID-19 on Cancer Screening: Challenges and Opportunities. JMIR Cancer. 2020 Oct 29;6(2):e21697. doi: 10.2196/21697.
Horn DM, Haas JS. Expanded Lung and Colorectal Cancer Screening - Ensuring Equity and Safety under New Guidelines. N Engl J Med. 2022 Jan 13;386(2):100-102. doi: 10.1056/NEJMp2113332. Epub 2022 Jan 8. No abstract available.
Gorin SNS, Jimbo M, Heizelman R, Harmes KM, Harper DM. The future of cancer screening after COVID-19 may be at home. Cancer. 2021 Feb 15;127(4):498-503. doi: 10.1002/cncr.33274. Epub 2020 Nov 10.
Frey B. Snowball Sampling. In: The SAGE Encyclopedia of Educational Research, Measurement, and Evaluation. 2018. https://dx.doi.org/10.4135/9781506326139.n636
Beebe J. Rapid Qualitative Inquiry: A Guide to Team Based Assessment.; 2014.
Gale RC, Wu J, Erhardt T, Bounthavong M, Reardon CM, Damschroder LJ, Midboe AM. Comparison of rapid vs in-depth qualitative analytic methods from a process evaluation of academic detailing in the Veterans Health Administration. Implement Sci. 2019 Feb 1;14(1):11. doi: 10.1186/s13012-019-0853-y.
Nevedal AL, Reardon CM, Opra Widerquist MA, Jackson GL, Cutrona SL, White BS, Damschroder LJ. Rapid versus traditional qualitative analysis using the Consolidated Framework for Implementation Research (CFIR). Implement Sci. 2021 Jul 2;16(1):67. doi: 10.1186/s13012-021-01111-5.
Taylor B, Henshall C, Kenyon S, Litchfield I, Greenfield S. Can rapid approaches to qualitative analysis deliver timely, valid findings to clinical leaders? A mixed methods study comparing rapid and thematic analysis. BMJ Open. 2018 Oct 8;8(10):e019993. doi: 10.1136/bmjopen-2017-019993.
Primary Completion
May 3, 2023
Actual (reported)Study Completion
July 31, 2023
Actual (reported)Last Updated
January 31, 2025
Results First Posted
January 31, 2025
Record last verified: 2025-01
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Source: ClinicalTrials.gov.
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