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OpenTrials
Completed

NCT Number: NCT04607291

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Health Service

Other

Receive Witness CARES services

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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