Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04683744 |
Other study ID # |
2012926551 |
Secondary ID |
CDR-2018C3-14715 |
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 11, 2021 |
Est. completion date |
July 2023 |
Study information
Verified date |
April 2021 |
Source |
Indiana University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
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.
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.