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Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach

Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03817905
Enrollment
5
Registered
2019-01-28
Start date
2019-09-01
Completion date
2020-06-30
Last updated
2025-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Positive FIT or Stool DNA Testing Follow up

Keywords

Colonoscopy, Fecal Immunochemical Testing

Brief summary

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.

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.

Interventions

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.

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

• Positive test for FIT or sDNA

Exclusion criteria

• Does not understand English

Design outcomes

Primary

MeasureTime frameDescription
Number of participants completing a follow-up colonoscopy procedureUp to 6 months from start of studyFeasibility 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026