RECRUITING

Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

mPATH-CRC (mobile Patient Technology for Health) is an automated direct-to-patient digital health program about colorectal cancer screening. The goal of this project is to test a cloud-based version of mPATH that patients can use at home independent of a scheduled medical visit. Patients will access mPATH on their own devices using a hyperlink sent via text message. The cloud version of mPATH will have the proven effective content of the tablet version, including the ability to request a screening test directly via the program. mPATH will then share this information with the patient's healthcare organization so screening can be arranged. This cloud-based version will be highly scalable, have broad reach, and be easy to support, making it a commercially viable product. This project will (1) test the reach and effectiveness of the mPATH web app in two different healthcare settings: a Fee-for-Service setting, and a value-based care setting; and (2) determine the value generated by mPATH in each healthcare setting.

Official Title

Effectiveness of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening

Quick Facts

Study Start:2025-06-09

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06821009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 74 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age 45-74 years 2. Be identified in the electronic health record as due for routine CRC screening, defined as 1. No colonoscopy in prior 10 years 2. No flexible sigmoidoscopy in prior 5 years 3. No CT colography in prior 5 years 4. No FIT-DNA test (Cologuard) within prior 3 years 5. No Fecal Occult Blood Test within prior 1 year 3. Have a cell phone number listed in the EHR 4. Have a preferred language of English or Spanish in the EHR 5. Upcoming appointment within 9 to 16 days 6. Georgia Market Only: Insurance type is listed as Medicare Advantage. 1. Prior diagnosis of colorectal cancer 2. Prior history of total colectomy 3. Currently enrolled in palliative care or Hospice 4. Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care 5. Age over 65 with frailty and advanced illness (as defined by the health system's My Panel metric which mirrors the HEDIS COL-E quality metric for CRC screening)	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

1. Age 45-74 years
2. Be identified in the electronic health record as due for routine CRC screening, defined as
1. No colonoscopy in prior 10 years
2. No flexible sigmoidoscopy in prior 5 years
3. No CT colography in prior 5 years
4. No FIT-DNA test (Cologuard) within prior 3 years
5. No Fecal Occult Blood Test within prior 1 year
3. Have a cell phone number listed in the EHR
4. Have a preferred language of English or Spanish in the EHR
5. Upcoming appointment within 9 to 16 days
6. Georgia Market Only: Insurance type is listed as Medicare Advantage.
1. Prior diagnosis of colorectal cancer
2. Prior history of total colectomy
3. Currently enrolled in palliative care or Hospice
4. Age over 65 AND currently enrolled in an Institutional SNP (I-SNP) or living in Long Term Care
5. Age over 65 with frailty and advanced illness (as defined by the health system's My Panel metric which mirrors the HEDIS COL-E quality metric for CRC screening)

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Aliza Randazzo

CONTACT

1-336-716-0844

arandazz@wakehealth.edu

David Miller, MD, MS

CONTACT

1-336-713-5218

dmiller@wakehealth.edu

Study Locations (Sites)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

Collaborators and Investigators

Sponsor: Digital Health Navigation Solutions, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-06-09

Study Completion Date2026-06-30

Terms related to this study

Additional Relevant MeSH Terms

Colorectal Cancer Screening