University of Pennsylvania
Philadelphia, Pennsylvania, 19003, United States
NCT Number: NCT07230795
This project aims to use machine learning algorithms (MLA) to identify and risk-stratify individuals between the ages of 45-49 who are more likely to have colorectal pathology and merit prioritized CRC screening and patient navigation. Patients deemed to be at higher risk for CRC by MLA will be randomized to an intervention group to receive risk-informed patient navigation and a usual care control group. The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. For the usual care control group, patients may still receive patient navigation for colonoscopy assistance. A referral to a nurse navigator can be initiated by a healthcare staff member in the following ways: 1) procedure scheduling staff will provide navigator's contact number if the patient expresses difficulty with obtaining a ride home 2) endoscopy staff and physicians can message navigator electronically 3) PCPs can place a navigation order in the EHR for patients deemed to need additional support such as with prep, education, transportation 4) providers will directly contact the director of the navigation system (Dr. Carmen Guerra) for referral.
Interested in participating?
Request Info45 year–49 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19003, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention arm will consist of a trained CRC navigator who will conduct outreach and navigation by interviewing these patients according to a script that consists of a statement of research, confirms eligibility, communicates their relative increased risk of CRC, assesses and addresses barriers to completion of CRC screening, and offers an adapted validated questionnaire regarding these barriers for patients to complete asynchronously. The navigator will be able to address barriers such as lack of awareness/knowledge about screening, misinformation, negative attitudes and fear, scheduling, inability to afford the prep, and lack of transportation and escort. The calls performed by the patient navigator will not be recorded.
Other names: Patient navigator
Time frame: 12 month
The patient navigation will assist in completing their colorectal cancer screening. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.
Time frame: 12 month
The patient navigation will assist in completing either a fecal immunochemical test (FIT) or a colonoscopy. The only test are either a fecal immunochemical test (FIT) or a colonoscopy. No other tests are required.
Time frame: 12 month
We will evaluate the effectiveness of the program on uptake of navigation and completion of CRC screening, rates of abnormal screening results, abnormal stool test follow-up with diagnostic colonoscopy, time to screening uptake, and CRC and precancerous lesion detection.
Time frame: Firtst 3 month
We will evaluate the effectiveness of the program on the uptake of navigation.
Time frame: Firtst 3 month
We will evaluate the effectiveness of the program on the uptake of navigation and completion of colorectal cancer screening.
Abramson Cancer Center at Penn Medicine
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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