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

Colorectal Carcinoma Clinical Trial

Official title:

Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04607291
• Other study ID #: I 63518
• Secondary ID: NCI-2019-06075I
• Status: Completed
• Phase: Phase 1
• Start date: September 1, 2019
• Est. completion date: May 14, 2021

Study information

• Verified date: August 2021
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Community Health Service
Receive Witness CARES services
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Screening Metrics	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
Primary	Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors	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	Prediction of Which CRC Screening Test is Most Acceptable	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