Patient Navigator for Positive Stool Test Follow-Up

Overseen By Gregory Cooper, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Does not understand English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a patient navigator (a healthcare guide) can help individuals follow up on abnormal stool tests. Specifically, it examines whether the navigator can assist in scheduling and completing a colonoscopy after a test shows blood or other unusual markers. Participants will meet with the navigator to discuss any challenges faced in completing their colonoscopy. This trial suits English-speaking individuals who have recently tested positive for blood or other markers in a stool test. As an unphased trial, it offers participants the opportunity to contribute to research that could enhance patient support and healthcare outcomes.

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 prior data suggests that the patient navigator is safe for improving follow-up care?

Research has shown that patient navigators are safe and well-received. They provide a supportive service rather than a medical treatment. Studies have found that patient navigators assist people in completing follow-up care after unusual test results, such as blood in stool tests.

For example, one study found that patient navigators significantly increased the likelihood of patients receiving necessary colonoscopies after such test results. No reports of harm have been associated with using patient navigators. They primarily assist by facilitating appointment scheduling and overcoming obstacles that might prevent individuals from receiving needed care.

Overall, patient navigation is a safe method to help ensure people receive necessary medical follow-up. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using a patient navigator for follow-up after a positive stool test because it addresses a crucial gap in care. Unlike standard treatments that focus on the medical procedure itself, this approach targets the human side of healthcare by providing personalized support. The patient navigator helps individuals overcome barriers to scheduling and completing their colonoscopy, which can improve outcomes by ensuring timely diagnosis and treatment. By focusing on patient experience and addressing logistical challenges, this method has the potential to increase screening completion rates and improve overall colon cancer care.

What evidence suggests that a patient navigator is effective for improving follow-up care after a positive stool test?

Research has shown that assisting patients in navigating the healthcare system can significantly enhance their follow-up care after a positive stool test. In this trial, participants will meet with a patient navigator at their colonoscopy appointment to discuss any issues encountered in completing the procedure. One study found that these navigation services increased colorectal cancer screening by 7.3% compared to regular care. Another review found that these programs encourage more people to participate in screening and follow-up tests. Patient navigation guides patients through the healthcare process and helps them overcome obstacles. Overall, it has been proven to increase the number of people who complete necessary follow-up screenings. ^{1 3 6 7 8}

Who Is on the Research Team?

Gregory Cooper, MD

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Patient navigator Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

Published Research Related to This Trial

Promotoras who delivered a healthy lifestyle intervention showed significant improvements in their health, including reductions in systolic and diastolic blood pressure and body mass index over a 6-month period.

This study highlights the positive impact of health interventions on promotoras themselves, suggesting that empowering community health workers can enhance their own health while they promote healthy behaviors in their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Delivering a Healthy Lifestyle Intervention: Promotora Findings from Familias Sanas y Activas II. Madanat, H., Martinez, A., Molina, M., et al.[2023]

The lay-led health navigator model in a rural New Zealand setting effectively supported vulnerable individuals facing multiple health barriers, demonstrating its importance in improving access to care in underserved areas.

Survey results indicated high satisfaction among users of the navigator service, highlighting its positive impact on connecting clients with health and social care services despite challenges in implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of a health navigator model of care within a primary care setting: a case study. Doolan-Noble, F., Smith, D., Gauld, R., et al.[2013]

Community health workers play a crucial role in bridging the gap between health providers and the community by offering various services such as health education, outreach, and case management, which enhances access to healthcare.

The study of community health worker programs across seven sites provides valuable insights and lessons that can help improve the effectiveness and implementation of similar programs in other communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of community health workers on access, use of services, and patient knowledge and behavior. Zuvekas, A., Nolan, L., Tumaylle, C., et al.[2019]

A significant majority (82%) of NCCCP action plans included activities related to patient navigators (PNs) and community health workers (CHWs), indicating a strong commitment to addressing health disparities in cancer care.

PNs were more frequently mentioned in these plans (83%) compared to CHWs (58%), with a focus on screening and survivorship, highlighting the importance of these roles in improving cancer prevention and control efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exploration of Patient Navigation and Community Health Worker Activities Across National Comprehensive Cancer Control Programs. Rohan, EA., McDougall, R., Townsend, JS.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"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]

A qualitative study involving 36 medically underserved cancer patients identified four key needs for effective patient navigation (PN) programs: improving access to quality care, addressing emotional and practical concerns, considering family issues, and supporting patients throughout their entire cancer journey from diagnosis to long-term survivorship.

Oncology social workers are positioned to play a crucial role in patient navigation, advocating for the inclusion of trained professionals to ensure that the specific needs of underserved cancer patients and their families are met.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social workers as patient navigators for breast cancer survivors: what do African-American medically underserved women think of this idea? Davis, C., Darby, K., Likes, W., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Patient navigation can significantly improve access to care and support for vulnerable cancer patients, particularly those with low income, low education, and multiple health issues, as shown by recent analyses of the Patient Navigation Research Program.

To be most effective, patient navigation programs should be tailored to address the specific challenges faced by these high-risk populations, requiring careful planning and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of evidence-based patient navigation programs. Freund, KM.[2017]

The study reviewed 27 articles on community health navigator (CHN) interventions for cancer screening, identifying two main models: community-based and clinic/hospital-based, each with distinct target populations and outreach strategies.

Both models of CHN interventions showed effective outcomes in promoting cancer screening, highlighting the importance of tailored approaches based on community needs and settings to address cancer disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on US-based community health navigator (CHN) interventions for cancer screening promotion--comparing community- versus clinic-based navigator models. Hou, SI., Roberson, K.[2021]

Community Health Workers (CHWs) have been effective in improving health access and outcomes since the 1960s, but they face challenges such as inconsistent funding and lack of support, which hinder their professional growth compared to Patient Navigators (PNs).

The National Association of Community Health Workers (NACHW) has been pivotal in advocating for better funding and support for CHWs, especially during the COVID-19 pandemic, highlighting the need for unity and leadership development within the profession to enhance their impact on marginalized populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a health profession: What oncology patient navigators can learn from the National Association of Community Health Workers. Rush, CH., Smith, DO., Fox, DJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12507143/

Findings from the Accelerating Colorectal Cancer Screening ... Patient navigation services can substantially boost participation in colorectal cancer screening and follow‐up. As part of the Accelerating ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831644

Mailed Outreach and Patient Navigation for Colorectal ... A mailed FIT outreach and patient navigation program led to a significant 7.3–percentage point increase in colorectal cancer (CRC) screening over usual care.

3. cdc.gov cdc.gov/pcd/issues/2025/25_0025.htm

Interventions to Increase Colorectal Cancer Screening ... We performed a scoping review to describe the types and effectiveness of interventions to increase CRC screening in primarily rural settings.

4. academic.oup.com academic.oup.com/jnci/article/115/6/680/7050938

Characteristics of patient navigation programs in the Cancer ... Patient navigation is an evidence-based intervention that has been shown to substantially improve rates of colorectal cancer (CRC) screening and ...

5. bmcglobalpublichealth.biomedcentral.com bmcglobalpublichealth.biomedcentral.com/articles/10.1186/s44263-025-00168-4

Effectiveness of a community health advisor colorectal cancer ... The trial demonstrated CHCs can increase CRC screening among African Americans who were not up to date in receiving recommended screening.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5586005/

Use of Community Health Workers and Patient Navigators ... Our findings support the effectiveness of CHW/PN programs to improve completion and timeliness of breast, cervical, and colorectal cancer screening in FQHCs.

7. cancercenter.arizona.edu cancercenter.arizona.edu/news/2025/04/patient-navigators-improve-colonoscopy-rates-after-abnormal-stool-tests-study-shows

Patient navigators improve colonoscopy rates after abnormal ... A University of Arizona Health Sciences-led study found that patients are more likely to get colonoscopies following abnormal stool test results ...

8. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.1002/cncr.34058

What makes for successful patient navigation implementation ... ... fecal occult blood testing, and stool DNA; however, patients receiving follow-up colonoscopy after a positive stool-based test are eligible.