Patient navigator for Positive FIT or Stool DNA Testing Follow up

1
Effectiveness
1
Safety
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center, Cleveland, OH
Patient navigator - Other
Eligibility
18+
All Sexes
Eligible conditions
Positive FIT or Stool DNA Testing Follow up

Study Summary

This study is evaluating whether a patient navigator can help improve follow up care after a stool test shows the presence of blood or other abnormal markers.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Patient navigator will improve 1 primary outcome in patients with Positive FIT or Stool DNA Testing Follow up. Measurement will happen over the course of Up to 6 months from start of study.

Month 6
Number of participants completing a follow-up colonoscopy procedure

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Trial Design

2 Treatment Groups

Control
Patient navigator

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Patient Navigator is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Patient navigator
Other
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 6 months from start of study
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 6 months from start of study for reporting.

Closest Location

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center - Cleveland, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
• Positive test for FIT or sDNA

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is positive fit or stool dna testing follow up?

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In a population as high as New South Wales, we demonstrated it was feasible and acceptable to undertake the positive stool DNA testing follow up, when a positive fit had not been performed. At the other extreme of the spectrum, it was found that in a population as low as Victoria, where a positive fit had been performed, there were no more positive results for the follow-up stool testing.

Unverified Answer

What are common treatments for positive fit or stool dna testing follow up?

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Recent findings indicate a significant discrepancy in what patients with positive fit or stool dna test results receive from primary care physicians to those with positive test results and also a discrepancy between the percentage of cases in which FIT or dna testing was recommended and what testing was undertaken in primary care. Recommendations should be developed for more effective, patient-centred communication between patients and primary care physicians regarding positive test results and treatment of cancer and should be communicated from an explicit guideline on cancer prevention.

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How many people get positive fit or stool dna testing follow up a year in the United States?

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During the first year follow up, approximately 3.4 million individuals were diagnosed on positive fit/stool dna testing. Among the 3.4 million, approximately 85,500 people (approximately 26% of the 3.4 million) were diagnosed with [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer) during the first year of follow up. Based on this data, positive fitting/stool testing is estimated to result in 0.05% of cancer cases in the United States.

Unverified Answer

Can positive fit or stool dna testing follow up be cured?

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Data from a recent study highlights the challenges of following up patients with positive tests at home. If an abnormality is not present it may be best to manage by a GP referral alone.

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What causes positive fit or stool dna testing follow up?

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When positive fit/stool testing is carried out immediately and not for 6 months post-baseline biopsy, a biopsy result that shows no atypical abnormality may be the cause of the positive result. If this is so, then a repeat test may be advisable 6 months after the initial positive test. When the result was normal an alternate explanation such as high sensitivity fecal occult blood testing must be pursued.

Unverified Answer

What are the signs of positive fit or stool dna testing follow up?

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After positive fit or stool dna testing, patients may have no symptoms. In certain cases, colonoscopy or barium enema can detect asymptomatic lesions or diverticular disease. Positive stool dna testing should be followed by positive fit or colonoscopy examination.

Unverified Answer

Have there been other clinical trials involving patient navigator?

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A formal clinical trial is underway to determine whether one or two visits using a patient navigator improves patient management in primary care. Results from a recent paper is underway in Ontario, Canada. http://public.researchgate.net/publication/14114449_A_patient_navigator_trial_for_primary_care_management_in_Ontario_Canada question: Is plasma leptin decreased in adults with short stature compared to non-short stature controls? answer: Results from a recent paper, we found a significant decrease of plasma leptin in adults with short stature compared to individuals of the same same height range but without short stature. This finding is in keeping with the inverse relationship between fasting plasma leptin and BMI.

Unverified Answer

How serious can positive fit or stool dna testing follow up be?

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[Even though stool dna testing follow up is important to investigate for coliform (Escherichia coli as well as Enterococcus faecalis) contamination in fecal microbiota transplantation, it may not be very important after 5 months or at least 6 months.

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What is the average age someone gets positive fit or stool dna testing follow up?

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The average age when a positive fit test is associated with positive fecal microbiota screening with a FST/FST+ was 10 years 2 months. Those who had positive stool FMT testing had the worst survival (30% post-testing survivorship). A positive FST/FST+ result is associated with poor survival in patients with CD4+>or=50 cell/mm. A positive FST/FST+ result does not seem to be associated with death from mycobacterium tuberculosis infection.

Unverified Answer

How does patient navigator work?

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The study demonstrates a valuable new approach to treatment for [colorectal cancer](https://www.withpower.com/clinical-trials/colorectal-cancer). It is feasible to use an NHS patient navigator to facilitate the clinical care of the cancer patient. It can also be deployed to assist patients in obtaining information for further self-management. It has the potential to reduce inequalities in the timing and the extent to which patients receive the clinical care we would want for our colorectal cancer care.

Unverified Answer

Have there been any new discoveries for treating positive fit or stool dna testing follow up?

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Positive fit has the highest chance of being negative in untreated patients. This is not the case in patients who have received treatment. At this time, positive fit is still not a definitive test for treatment. This will hopefully change as studies are carried out to prove that positive fit can also be negative if the patient has received treatment. Although there may be potential for treating negative fits, it is not possible to make any firm conclusions without further studies. In addition, negative fits are highly unlikely to be negative if treatment has been received. At this time, it is also unclear which types and amounts of treatment result in better or worse success.

Unverified Answer

Is patient navigator typically used in combination with any other treatments?

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The majority of the patients seen were eligible for the patient navigator referral. Patients eligible for a referral were more likely to complete referral. There were no significant effects of patient navigator services combined with any other treatments.

Unverified Answer
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