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

NCT ID: NCT03817905

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-06-30

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.

Conditions

Positive FIT or Stool DNA Testing Follow up

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient navigator

Intervention Type: OTHER

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.

Interventions

Patient navigator

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Positive test for FIT or sDNA

Exclusion Criteria

• Does not understand English

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Cooper, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Locations

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE1219

Identifier Type: -

Identifier Source: org_study_id