Trial Title:
mPATH-Cloud for Colorectal Cancer Screening
NCT ID:
NCT06441487
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
screening
digital health platform
mPATH™
Mobile Patient Technology for Health
fecal immunochemical tests
fecal occult blood test
Cancer Screening
Community Health Centers
Implementation Science
Rural health
Telemedicine
Minority Health
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Randomized: Participants are assigned to intervention groups by chance.
Primary purpose:
Screening
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Mobile Health Decision Support
Description:
Subjects randomized to this arm receive a link to a mobile health decision support tool
(mPATH™- Cloud). Within mPATH™-Cloud, subjects are invited to answer brief questions to
confirm eligibility, view a video to help them identify their CRC screening preference,
and request either colonoscopy or fecal immunochemical test (FIT) screening from their
primary care provider. Subjects who select FIT, as well as subjects who do not click on
the link or select a screening test receive a FIT mailed to their home address.
Arm group label:
Trial Mailed FIT Intervention
Other name:
mPATH™-Cloud
Intervention type:
Behavioral
Intervention name:
Usual care
Description:
The study team will send subjects a prompt to visit the mobile health decision support
tool (mPATH™-Cloud). Subjects with a mobile phone (as determined by their electronic
health record) will receive a link to mPATH-Cloud by text. Subjects with a mailing
address, but no mobile phone number in the EHR, will receive a letter inviting them to
access mPATH-Cloud via URL code. Within mPATH-Cloud, subjects are invited to answer brief
questions to confirm eligibility, view a video to help them identify their CRC screening
preference, and request either colonoscopy or fecal immunochemical test (FIT) screening
from their primary care provider. Subjects who do not click on the link or select a
screening test receive a FIT.
Arm group label:
Trial Usual Care
Summary:
This study assesses the effectiveness of colorectal cancer (CRC) screening intervention,
mobile Patient Technology for Health (mPATH™-Cloud), compared to usual care among
subjects who are overdue for CRC screening according to recommendations of the United
States Preventive Services Taskforce (USPSTF). The trial randomly selects and enrolls
1,000 eligible subjects served by one federally qualified health center (FQHC) in North
Carolina. Subjects are randomized to two study arms, Usual Care (Arm 1) or Mobile Health
Decision Support (Arm 2).
Usual care consists of a visit-based screening recommendation to complete a stool test
(e.g., FOBT, FIT, Cologuard) or referral to a screening colonoscopy. Subjects randomized
to the Mobile Health Decision Support (Arm 2) are sent a message by text or US mail,
depending on their preferred communication mode as indicated in the electronic health
record (EHR), to visit the mPATH™-Cloud website. Subjects who engage with mPATH™-Cloud
are invited to answer brief questions to confirm their eligibility and then view a short
decision aid video designed to help people choose the CRC screening test (FIT or
colonoscopy) that they would like to receive. After watching the video, subjects can
choose a CRC screening test. Their primary care provider at the FQHC orders the
appropriate test and, where indicated, refers the subjects to a colonoscopy. Subjects who
request FIT screening and subjects who do not select any test receive a FIT mailed to
their home address.
The primary outcome of interest is CRC screening completion within 6 months after
randomization as assessed by EHR chart review. A completed screening is any of the
following: colonoscopy completion (regardless of indication); 2) at least one FIT test
with a normal result; or diagnostic colonoscopy following an abnormal FIT result. We
hypothesize that we will observe a higher CRC screening completion rate in the Mobile
Health Decision Support intervention arm (Arm 2).
This study includes up to three annual rounds of screening eligibility assessment and
outreach. Repeated intervention rounds allow us to evaluate whether the intervention can
improve adherence to USPSTF recommendations over time. During the 3-year intervention
phase, Arm 1 receives usual care only.
Detailed description:
Subjects randomized to the Mobile Health Decision Support intervention arm (Arm 2)
receive a link to mobile Patient Technology for Health (mPATH™-Cloud), a digital health
platform designed to alleviate the implementation burden on clinical teams by automating
many key steps in the CRC screening process. If the subject uses mPATH-Cloud to select a
screening test, mPATH-Cloud notifies the subject's primary care provider at the FQHC.
Subjects who request colonoscopy are then referred by their primary care provider to
colonoscopy as appropriate. Subjects who request FIT receive a FIT mailed to their home.
Primary outcome assessment: To assess intervention effectiveness, CRC screening
completion within 6 months of randomization (primary outcome) is assessed by EHR chart
review. Screening completion is defined as any of the following: colonoscopy completion
(regardless of indication); at least one FIT test with a normal FIT result; or diagnostic
colonoscopy following an abnormal FIT result.
Secondary outcome assessment: To assess intervention effectiveness on adherence to USPSTF
recommendations over time (secondary outcome), the Mobile Health Decision Support
intervention is offered annually to Arm 2 subjects for up to 3 consecutive years so long
as the subject remains eligible and due for CRC screening as determined by EHR review.
CRC screening up-to-datedness will be assessed by EHR chart review over a period of three
consecutive years. FIT should be repeated annually, and colonoscopy typically only needs
to be repeated once every 10 years. Thus, subjects will be assigned one year per annual
FIT completed (e.g., FIT in years 1, 2, and 3 would be assigned 3 years; FIT in year 1,
and 3 would be assigned 2 years) and up to 3 years for colonoscopy depending on the year
received (e.g., colonoscopy in year 1 would be assigned 3 years, colonoscopy in year 3
would be assigned 1 year). Subjects remain in their originally assigned study arms for
the duration of up to three annual rounds of CRC screening outreach.
Implementation assessment (exploratory outcome): This study will identify implementation
processes and outcomes that will impact future dissemination and scalability. After the
trial phase concludes, researchers will interview a subsample of up to 50 subjects to
understand factors associated with CRC screening completion among subjects with varying
needs and preferences.
Criteria for 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
Gender:
All
Minimum age:
45 Years
Maximum age:
73 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Lineberger Comphrehensive Cancer Center at University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Contact:
Last name:
Alexis A Moor, MPH
Investigator:
Last name:
Leah M Frerichs, PhD
Email:
Principal Investigator
Facility:
Name:
Wake Forest University
Address:
City:
Winston-Salem
Zip:
27157
Country:
United States
Contact:
Last name:
Aliza Randazzo
Phone:
336-716-0844
Investigator:
Last name:
David P Miller, MD, MS
Email:
Principal Investigator
Start date:
December 30, 2024
Completion date:
January 2029
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06441487
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
