Clinical trial NCT04607291: Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Official title: Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-10-29
Enrollment: 183
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This phase I study investigates how well a health service program called Witness CARES Services works in increasing access and adherence to colorectal cancer screening in patients who have not undergone a colorectal screening in the past year. Providing patients with navigational and screening services via Witness CARES Services may improve access to and adherence levels of colorectal screening.

Detailed description: PRIMARY OBJECTIVES:

I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients.

II. Develop an algorithm for predicting CRC screening outcomes following intervention services.

OUTLINE:

Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test receive navigator assistance by facilitating fecal tests.

After completion of study, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years)
* Medicaid or Medicaid/Medicare subscribers
* Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program

Exclusion Criteria:

* Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded
* Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening
* Participants symptomatic for CRC will be excluded from the study

Primary outcomes:
measure: Change in Screening Metrics
timeFrame: Up to 12 months
measure: Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors
timeFrame: Up to 12 months
Secondary outcomes:
measure: Prediction of Which CRC Screening Test is Most Acceptable
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Deborah Erwin
role: PRINCIPAL_INVESTIGATOR
References: