Clinical Trials /

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

NCT03817905

Description:

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.

Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
  • Official Title: Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach

Clinical Trial IDs

  • ORG STUDY ID: CASE1219
  • NCT ID: NCT03817905

Conditions

  • Positive FIT or Stool DNA Testing Follow up

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Patient navigatorExperimentalParticipant 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.

    Eligibility Criteria

            Inclusion Criteria:
    
            • Positive test for FIT or sDNA
    
            Exclusion Criteria:
    
            • Does not understand English
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:40 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Number of participants completing a follow-up colonoscopy procedure
    Time Frame:Up to 6 months from start of study
    Safety Issue:
    Description: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.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Case Comprehensive Cancer Center

    Trial Keywords

    • Colonoscopy
    • Fecal Immunochemical Testing

    Last Updated

    March 23, 2021