Smartphone App for Colorectal Cancer Screening
(SHIELD-TX Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a new blood-based screening test for colorectal cancer (CRC) might encourage more people to adhere to regular screening schedules. Researchers aim to determine if a smartphone app can improve follow-up, particularly for those needing further testing after a positive result. Participants will either use the app for reminders and information or receive standard support without it. Ideal candidates are individuals without a history of CRC who have recently seen their doctor and have access to a specific healthcare app. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in CRC screening and patient follow-up.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that this blood-based screening test is safe for colorectal cancer screening?
Research shows that blood tests for screening colorectal cancer are generally safe. Studies have found that these tests are approved for detecting colorectal cancer, with an accuracy of 83% in identifying the disease. This indicates that the tests are reliable and have passed safety checks for approval.
While the blood tests are less effective at finding advanced precancerous growths, no specific safety issues have been reported, suggesting they are well-tolerated by patients. Reports of serious side effects are absent, making these tests a promising screening option. Therefore, participating in a trial with these tests is likely a safe choice.1234Why are researchers excited about this trial?
Researchers are excited about the smartphone app intervention for colorectal cancer screening because it leverages digital technology to enhance patient engagement and education. Unlike traditional methods that rely heavily on direct patient-provider interactions, this app sends educational messages directly to patients via their healthcare portal smartphone app. This approach aims to improve the rate at which patients follow up on positive blood test results by making information more accessible and timely. By potentially increasing the adherence to follow-up procedures like colonoscopies, the app could lead to earlier detection and treatment of colorectal cancer, which is crucial for better patient outcomes.
What evidence suggests that this trial's treatments could be effective for colorectal cancer screening?
Research has shown that blood-based screening tests (BBST) for colorectal cancer (CRC) are promising tools. One study found that these tests accurately identify 83% of CRC cases and correctly rule out 90% of those without cancer. This means they effectively detect real cancer cases with minimal false alarms. Although they may not be as effective at spotting advanced precancerous growths, they do aid in early cancer detection. Early detection is crucial because it makes treatment easier and more effective. BBSTs can also encourage more people to get screened, which is important for catching cancer before it worsens.
In this trial, participants will be divided into two groups: one receiving educational messages via a smartphone app as part of the app intervention arm, and the other receiving standard support. The app intervention aims to enhance the effectiveness of BBSTs by increasing awareness and encouraging timely follow-up actions.45678Are You a Good Fit for This Trial?
This trial is for individuals aged 45-84 who are at average risk for colorectal cancer, as per guidelines. Participants must be willing to provide blood samples and have been seen in a specific clinic within the last two years. They also need an active smartphone app account or must create one during recruitment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Blood-Based Screening Test (BBST)
Participants undergo a blood-based screening test for colorectal cancer
Intervention
Participants receive either standard support or app-based intervention to improve follow-up adherence
Follow-up BBST
Participants with a negative initial BBST undergo a follow-up BBST
Follow-up
Participants are monitored for safety and effectiveness after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Blood-Based Screening Test
Trial Overview
The study is testing if using a smartphone app with educational information can improve people's acceptance of and adherence to colorectal cancer screening via blood tests, and whether it affects follow-up rates for further testing or colonoscopy after initial results.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients on the app intervention arm will receive educational messages via their healthcare portal smartphone app.
Patients on the standard support arm who receive a positive blood test result and either do not access their healthcare portal smartphone app and/or do not schedule a colonoscopy within 2 weeks of the blood test result will receive the standard patient navigation support offered which typically includes explanation and education regarding their positive test result and referral to a gastroenterologist or other proceduralist for a colonoscopy.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor Research Institute
Lead Sponsor
Citations
Colorectal cancer screening blood test: awareness and ... - PMC
Screening tests are effective and cost-effective in the prevention of CRC or in the identification of CRC in early stages when it is easier to ...
Comparative benefits, burdens, and harms of emerging blood ...
Emerging blood tests may improve colorectal cancer (CRC) screening uptake and outcomes but are less sensitive for advanced precancerous lesions ...
3.
investors.guardanthealth.com
investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Health-ECLIPSE-Study-Data-Demonstrating-Efficacy-of-Shield-Blood-based-Test-for-Colorectal-Cancer-Screening-to-be-Published-in-The-New-England-Journal-of-Medicine/default.aspxPress Releases
Study shows blood-based cancer screening test detects 83% of people with colorectal cancer with specificity of 90% Results pave the way for ...
4.
gastro.org
gastro.org/press-releases/new-data-offer-reality-check-on-blood-based-colorectal-cancer-screening/New data offer reality check on blood-based colorectal ...
A blood test will be better than nothing, but may lead to more colorectal cancer cases and deaths than established screening tests.
Effectiveness and Cost-Effectiveness of Colorectal Cancer ...
In this study, we evaluated the effectiveness and cost-effectiveness of a hypothetical blood-based CRC screening test that meets the CMS ...
Comparative benefits, burdens, and harms of emerging blood ...
Emerging blood tests may improve colorectal cancer (CRC) screening uptake and outcomes but are less sensitive for advanced precancerous lesions ...
7.
cancer.gov
cancer.gov/news-events/cancer-currents-blog/2024/shield-blood-test-colorectal-cancer-screeningShield Blood Test Approved for Colorectal Cancer Screening
Overall, in addition to its 83% sensitivity for identifying colorectal cancers and 13% of advanced precancerous polyps found by colonoscopy, the ...
ASGE Position on Blood-Based Colorectal Cancer Screening
ASGE has determined that blood-based tests are inferior to established screening options (i.e., colonoscopy and stool-based tests), especially ...
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