mPATH-Cloud for Colorectal Cancer Screening

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · May 28, 2024

Keywords

ClinConnect Summary

The mPATH-Cloud for Colorectal Cancer Screening trial is studying a new way to encourage people to get screened for colorectal cancer (CRC). This study aims to see if using a mobile health tool called mPATH™-Cloud helps more people complete their screenings compared to the usual care they would receive. The trial will involve 1,000 adults aged 45 to 73 who are overdue for screening and are considered to be at average risk for CRC. Participants will be randomly assigned to either receive standard care, which typically involves a recommendation for a stool test or a colonoscopy, or the mPATH™-Cloud intervention, which provides them with helpful information through text or mail on how to choose and request their screening test.

To be eligible for this trial, participants must be between 45 and 73 years old, have no personal or family history of colorectal cancer or related conditions, and must not have had any recent CRC screenings. Those who join the study can expect to receive support and guidance on the screening process, including a short video that will help them decide which test is best for them. The main goal is to see if those using the mPATH™-Cloud tool will complete their screenings within six months at a higher rate than those receiving usual care. This study will also assess the effectiveness of this approach over three years, making it a significant effort to improve CRC screening rates.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 45-73 years at time of enrollment
• • At average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: documented history in the EHR of CRC, colonic adenomas, family history of CRC, or diagnosis of inflammatory bowel disease)
• • No record in the EHR of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
• • No record in the EHR of any CRC diagnosis or total colectomy
• • Active patient of the clinic as documented in the EHR (seen at least 2 times within the past 12 months)
• • For the second and third study rounds only: No record of a positive (abnormal) CRC screening result in a previous study round
• Exclusion Criteria:
• * All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation:
• • Age younger than 45 years or older than 73 years at the time of enrollment
• • Not at average risk for CRC ("average risk" is defined as those subjects who do not have any of the following: history with colorectal carcinoma, colonic adenomas, family history of colorectal carcinoma, or diagnosis of inflammatory bowel disease)
• • Colorectal carcinoma screening in last 12 months Record in the electronic health record (HER) of fecal occult blood test (FOBT)/FIT within 12 months, FIT-DNA within 3 years, colonoscopy within 10 years, sigmoidoscopy within 5 years, barium enema within 5 years, or computed tomography (CT) colonography within 10 years of the EHR query date
• • Record in the EHR any CRC diagnosis or total colectomy
• • Not an active client of the clinic as documented in the EHR (not seen at least 2 times within the past 12 months)
• • For second and third annual study rounds only: Record of a positive (abnormal) CRC screening result in a previous study round