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

Phase 1
Completed
Conditions
Colorectal Carcinoma
Interventions
Other: Community Health Service
Other: Survey Administration
Registration Number
NCT04607291
Lead Sponsor
Roswell Park Cancer Institute
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
183
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Health services research (Witness CARES services) InterventionCommunity Health ServicePatients 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.
Health services research (Witness CARES services) InterventionSurvey AdministrationPatients 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.
Primary Outcome Measures
NameTimeMethod
Change in Screening MetricsUp to 12 months

After CRC screening, satisfaction surveys will be conducted in order to assess the services of the Witness Cares Program.

Below are responses to basic follow-up questions.

Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening BehaviorsUp to 12 months

A telephone assessment of 118 self reported questions will be conducted in order to assess what factors are associated with CRC screening.

The outcome of interest is CRC screening (colonoscopy or fecal immunochemical testing (FIT) test), which is treated as a binary outcome.

The potential predictors include basic demographic characteristics as well as the survey sub-scales (based on the 118 self-reported questions).

Secondary Outcome Measures
NameTimeMethod
Prediction of Which CRC Screening Test is Most AcceptableUp to 12 months

Data collected from surveys from the intent to screen clients will be used to help predict CRC screening test most acceptable

Trial Locations

Locations (1)

Roswell Park Cancer Institute

🇺🇸

Buffalo, New York, United States

Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
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