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Trial Title:
Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity
NCT ID:
NCT06542835
Condition:
Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
cancer screening
telehealth
video
text messaging
patient navigation
stool testing
fecal testing
Latinx health disparities
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Video text message
Description:
Video text messages tailored to the Latinx population to educate and motivate patients to
complete CRC screening.
Arm group label:
Video text message, mailed FIT, and social needs navigation
Intervention type:
Behavioral
Intervention name:
In-clinic CRC screening promotion
Description:
Stool-test orders, colonoscopy referrals.
Arm group label:
Usual care
Intervention type:
Behavioral
Intervention name:
Mailed FIT
Description:
Mailed FIT kits.
Arm group label:
Video text message, mailed FIT, and social needs navigation
Intervention type:
Behavioral
Intervention name:
Social needs navigation
Description:
Patient navigation to address social needs.
Arm group label:
Video text message, mailed FIT, and social needs navigation
Intervention type:
Behavioral
Intervention name:
Reminders
Description:
Centralized text and/or telephone reminders for ordered tests.
Arm group label:
Usual care
Summary:
Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening
intervention.
Detailed description:
The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among
predominantly Latinx populations by using video text messages, mailed FIT kits, and
patient navigation. The study will address multi-level barriers to screening, including
misinformation, lack of access, and social determinants of health. The hypothesis is that
a multi-component intervention will increase CRC screening rates and follow-up care,
reducing disparities in CRC outcomes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Ages 45-64
- Eligible for colorectal cancer (CRC) screening
- Current patients (seen in the clinic in the last 6 months)
- Primary speaker of English or Spanish
- Cell phone listed in Electronic Health Record (EHR)
- No recent history of CRC screening
- Resides in one of the neighborhoods included in the main trial
Exclusion Criteria:
- Colorectal disease (e.g., ulcerative colitis or colectomy)
- Personal history of colorectal cancer
- End-stage or life-threatening diseases
- Known to be under hospice care
- Living in a skilled nursing facility
- Patients who decline research participation will be removed from the patient contact
list
Gender:
All
Minimum age:
45 Years
Maximum age:
64 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
AltaMed Health Services Corporation
Address:
City:
Los Angeles
Zip:
90040
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anne Escaron, PhD
Phone:
323-695-3601
Email:
aescaron@AltaMed.org
Start date:
July 31, 2024
Completion date:
January 2027
Lead sponsor:
Agency:
University of Arizona
Agency class:
Other
Collaborator:
Agency:
San Diego State University
Agency class:
Other
Collaborator:
Agency:
AltaMed Health Services Corporation
Agency class:
Other
Collaborator:
Agency:
Kaiser Permanente
Agency class:
Other
Source:
University of Arizona
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06542835
