30 Participants Needed

Patient Navigator for Positive Stool Test Follow-Up

GC
Overseen ByGregory Cooper, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Case Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Patient navigator, Care Coordinator, Patient Advocate, Outreach Coordinator, Promotores (as) de Salud, Community Health Representative (CHR), Community Health Worker (CHW) for positive stool test follow-up?

Research shows that patient navigators, who help guide patients through the healthcare system, can speed up diagnosis and treatment, especially in underserved communities. This approach has been effective in cancer care and improving care transitions for various conditions, suggesting it could also help with follow-up after a positive stool test.12345

Is the use of patient navigators and community health workers safe for humans?

Patient navigators and community health workers have been used for many years in various health programs and are generally considered safe. They help connect people with health services and provide support, and there is no evidence suggesting they pose any safety risks to humans.46789

How is the Patient Navigator treatment unique for positive stool test follow-up?

The Patient Navigator treatment is unique because it involves trained healthcare workers who help patients overcome personal and environmental barriers to access healthcare, ensuring timely follow-up and treatment, especially for underserved populations. This approach is different from traditional medical treatments as it focuses on providing personalized support and guidance rather than direct medical intervention.1491011

What is the purpose of this trial?

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.

Research Team

GC

Gregory Cooper, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for individuals who had a stool test that detected blood or abnormal markers, indicating the need for follow-up care. Participants must understand English to be eligible.

Inclusion Criteria

Positive test for FIT or sDNA

Exclusion Criteria

I do not understand English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants meet with a patient navigator at their colonoscopy appointment to discuss any barriers to scheduling and completion

Single visit
1 visit (in-person)

Follow-up

Participants are monitored for completion of follow-up colonoscopy procedure

Up to 6 months

Treatment Details

Interventions

  • Patient navigator
Trial Overview The study is testing if having a patient navigator can improve the process of getting follow-up care after an individual's stool test comes back positive for potential issues.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Patient navigatorExperimental Treatment1 Intervention
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.

Patient navigator is already approved in United States for the following indications:

🇺🇸
Approved in United States as Patient Navigator for:
  • Improving follow-up care after positive FIT or stool DNA testing
  • Increasing participation in cancer screening
  • Colorectal cancer screening

Find a Clinic Near You

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials
472
Recruited
33,400+

Findings from Research

Patient navigation significantly reduces the time it takes for patients in underserved populations to receive a diagnosis and start treatment for cancer, based on a systematic review of 16 studies.
The effectiveness of patient navigation is enhanced when initial contact occurs soon after diagnostic or screening tests, highlighting the importance of timely intervention.
Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers.Bush, ML., Kaufman, MR., Shackleford, T.[2022]
The PArTNER study aims to evaluate the effectiveness of a multi-faceted Navigator intervention, which includes community health worker visits and peer coaching, in improving patient experiences during hospital-to-home transitions for patients with conditions like heart failure and pneumonia.
This pragmatic clinical trial will assess changes in emotional distress and informational support among patients, with a focus on understanding barriers and facilitators to implementing the Navigator intervention across diverse patient populations.
Design of the patient navigator to Reduce Readmissions (PArTNER) study: A pragmatic clinical effectiveness trial.Prieto-Centurion, V., Basu, S., Bracken, N., et al.[2023]
The study involved nine participants who worked with medical students over an 18-month period, revealing that patient navigators significantly improved access to healthcare and overall patient experience, especially for those with chronic illnesses.
Participants reported that their relationships with medical students were therapeutic, leading to improvements in both mental and physical health, and they found fulfillment in teaching students about empathy through their lived experiences.
"They were an advocate for me": A Qualitative Study Exploring Medical Student Longitudinal Relationships and Patient Well-Being.Risotto-Urbanowicz, E., Vega, T., Caron, R., et al.[2023]

References

Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers. [2022]
Design of the patient navigator to Reduce Readmissions (PArTNER) study: A pragmatic clinical effectiveness trial. [2023]
"They were an advocate for me": A Qualitative Study Exploring Medical Student Longitudinal Relationships and Patient Well-Being. [2023]
A systematic review on US-based community health navigator (CHN) interventions for cancer screening promotion--comparing community- versus clinic-based navigator models. [2021]
Social workers as patient navigators for breast cancer survivors: what do African-American medically underserved women think of this idea? [2022]
Impact of community health workers on access, use of services, and patient knowledge and behavior. [2019]
An Exploration of Patient Navigation and Community Health Worker Activities Across National Comprehensive Cancer Control Programs. [2020]
8.Trinidad and Tobagopubmed.ncbi.nlm.nih.gov
Impact of Delivering a Healthy Lifestyle Intervention: Promotora Findings from Familias Sanas y Activas II. [2023]
Establishing a health profession: What oncology patient navigators can learn from the National Association of Community Health Workers. [2022]
Implementation of evidence-based patient navigation programs. [2017]
Evolution of a health navigator model of care within a primary care setting: a case study. [2013]
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