Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening

Roswell Park Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: Colorectal Carcinoma

Treatments: Other: Community Health Service; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04607291

P30CA016056 (U.S. NIH Grant/Contract)

R41CA232824 (U.S. NIH Grant/Contract)

NCI-2019-06075 (Registry Identifier)

I 63518 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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183 participants in 1 patient group

Health services research (Witness CARES services) Intervention

Experimental group

Description:

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 navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.

Treatment:

Other: Survey Administration

Other: Community Health Service