- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04683744
Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study team will engage with the leadership, staff, and providers in the study team's partner healthcare systems, to identify facilitators and barriers to implementing patient decision aids and provider notifications as well as cancer risk assessment tools, for colorectal cancer screening, and for other evidence-based cancer screening during the COVID pandemic and, potentially, after the conclusion of the pandemic.
At the conclusion of the study, the investigators will have extensive information regarding how best to provide decision aids through an electronic health record (EHR) portal, with or without personalized information, and to deliver provider notifications, which can guide broader implementation.
The study will involve interviews with staff and providers at the study team's partner healthcare systems to identify facilitators and barriers to implementing decision aids and provider notifications for colorectal cancer screening.
Also, the investigators will interview patients to identify perceptions of prevention during the COVID-19 pandemic including risk perception and barriers to screening, perceptions of risk from both the pandemic and disease, and patient cancer screening and risk prevention behaviors engaged in or postponed during the pandemic and patient rationales for their decisions. This part of the study will suggest potentially promising approaches for providing prevention and disease management during the COVID-19 pandemic.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 462020
- Indiana University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Health system participants will be eligible if:
- they are employed by one of the study team's partner healthcare systems.
Patient participants will be eligible if:
- they have had a primary care visit during the past 24 months
- they have completed cancer screening during the past 5 years prior to 2020 for breast, cervical or lung cancer as noted in the electronic health record (EHR)
- age 50 years or older
- speaks English
- accessible by phone.
Exclusion Criteria:
Patients will be excluded if:
- they did not complete any cancer screening for breast, colon, cervical, or lung cancer during the past 5 years prior to 2020
- did not complete a primary care visit at a partner healthcare system during the past 2 years.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Healthcare system leadership, providers, and staff
Leadership, providers, and staff at the study team's affiliated health systems.
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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.
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Patients receiving primary care 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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.
Time Frame: 2 years
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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.
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2 years
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Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff.
Time Frame: 9 months
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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.
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9 months
|
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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.
Time Frame: 6 months
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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.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Schwartz, MD, PhD, Indiana University
Publications and helpful links
General Publications
- 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.
- 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. Erratum In: JAMA Netw Open. 2020 Sep 1;3(9):e2020927. doi: 10.1001/jamanetworkopen.2020.20927.
- 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.
- 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. Erratum In: Cancer. 2021 Nov 15;127(22):4315. doi: 10.1002/cncr.33519.
- 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.
- 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.
Helpful Links
- Epic Health Research Network. Preventive Cancer Screenings during COVID-19 Pandemic.
- Centers for Medicare and Medicaid Centers for Medicare and Medicaid Services (CMS). Medicare telemedicine snapshot: Medicare claims and encounter data: March 1, 2020 to February 28, 2021. Received by September 9, 2021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012926551
- CDR-2018C3-14715 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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