Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health services research (Witness CARES services) Intervention
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.
|
Ancillary studies
Receive Witness CARES services
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Screening Metrics
Time Frame: Up 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. |
Up to 12 months
|
|
Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors
Time Frame: Up 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). |
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prediction of Which CRC Screening Test is Most Acceptable
Time Frame: Up to 12 months
|
Data collected from surveys from the intent to screen clients will be used to help predict CRC screening test most acceptable
|
Up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Deborah Erwin, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 63518 (Other Identifier: Roswell Park Cancer Institute)
- P30CA016056 (U.S. NIH Grant/Contract)
- NCI-2019-06075 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R41CA232824 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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