Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03817905|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : July 7, 2022
|Condition or disease||Intervention/treatment||Phase|
|Positive FIT or Stool DNA Testing Follow up||Other: Patient navigator||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||December 2024|
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.
Other: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817905
|Contact: Gregory Cooper, MD||1-800-641-2422||CTUReferral@UHhospitals.org|
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Gregory Cooper, MD 800-641-2422 CTUReferral@UHhospitals.org|
|Principal Investigator:||Gregory Cooper, MD||University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center|