Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
June 12, 2025 updated by: Case Comprehensive Cancer Center
This study seeks to determine whether a patient navigator can help improve follow up care after a stool test shows the presence of blood or other abnormal markers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants who recently had a stool test that had abnormal results will be asked to participate in this study in order to determine whether the use of a navigator can increase the use of colonoscopy, which is the recommended follow up to an abnormal stool test.
A navigator is an individual trained to help patients access necessary health care services and understand the test results and next steps.
Participants will be asked to meet the navigator at their colonoscopy appointment and discuss any problems that are experienced in getting the colonoscopy done.
This will take about 10 minutes to complete.
Participants will tell him or her in their own words how the experience was and whether they faced any barriers to scheduling and colonoscopy completion.
Study personnel will also look at participants' electronic medical record to see what testing participants had done that prompted the need for colonoscopy.The study will include about 30 people.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Positive test for FIT or sDNA
Exclusion Criteria:
• Does not understand English
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patient navigator
Participant meets the patient navigator at their colonoscopy appointment and discusses any problems they experienced in getting the colonoscopy done.
Participant will tell navigator in their own words their experience and whether they faced any barriers to scheduling and colonoscopy completion.
|
Intervention will utilize staff at the Seidman Cancer Center who are trained in patient navigation and have experience in navigating patients for breast cancer screening as well as sickle cell disease.
The staff will undergo training for this study by study principal investigators which will include the target participant population, necessary steps in the navigation process and data that will be collected.
In addition, they will receive brief training in supportive, listening technique.
They will also be furnished with a telephone script for the initial participant contact.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants completing a follow-up colonoscopy procedure
Time Frame: Up to 6 months from start of study
|
Feasibility of a navigator based intervention to improve follow up will be determined by comparing the colonoscopy completion rate to historical controls.
This will be measured as number of participants completing a follow-up colonoscopy procedure.
|
Up to 6 months from start of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gregory Cooper, MD, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
June 30, 2020
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
January 24, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (Actual)
January 28, 2019
Study Record Updates
Last Update Posted (Actual)
June 15, 2025
Last Update Submitted That Met QC Criteria
June 12, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CASE1219
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.