Completed

NCT Number: NCT03817905

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

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.

Completed

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Key information

Conditions

Positive FIT or Stool DNA Testing Follow up

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Positive test for FIT or sDNA

Exclusion criteria

Does not understand English

Treatment and study plan

Patient Navigator

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center