Positive FIT or Stool DNA Testing Follow upNCT03817905
Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
A study testing Patient navigator in people with Positive FIT or Stool DNA Testing Follow up, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Positive FIT or Stool DNA Testing Follow up
- What is being tested?
- Patient navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive test for FIT or sDNA
Who cannot join
- Does not understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Being tested
- Patient navigator
- Keywords
- Colonoscopy, Fecal Immunochemical Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient navigatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient navigator | Experimental | 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. Receives: Other: Patient navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants completing a follow-up colonoscopy procedure
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.
Measured: Up to 6 months from start of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Sep 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive FIT or Stool DNA Testing Follow upStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Cooper, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817905
- Sponsor's protocol ID
- CASE1219
- Status last verified
- Jun 2025
- First submitted
- 24 Jan 2019
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incomplete Follow Up After Positive FIT or Stool DNA Testing: A Multimethod Approach
- ClinicalTrials.gov ID
- NCT03817905
- Acronym / sponsor ID
- CASE1219
- Keywords
- Colonoscopy, Fecal Immunochemical Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient navigator | Experimental | Other: Patient navigatorParticipant 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Positive test for FIT or sDNA
Key exclusion criteria (1 listed)
- Does not understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient navigatorIntervention 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. | Other | Patient navigator |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Cooper, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient navigator in people with Positive FIT or Stool DNA Testing Follow up, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants completing a follow-up colonoscopy procedure (time frame: Up to 6 months from start of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.