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

30 Participants Needed

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. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{1 4 9 10 11}

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

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

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+

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.

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]

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]

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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Adherence in the Cancer Care Setting: a Systematic Review of Patient Navigation to Traverse Barriers. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Design of the patient navigator to Reduce Readmissions (PArTNER) study: A pragmatic clinical effectiveness trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

"They were an advocate for me": A Qualitative Study Exploring Medical Student Longitudinal Relationships and Patient Well-Being. [2023]

4. England 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. [2021]

5. United States 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? [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of community health workers on access, use of services, and patient knowledge and behavior. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

An Exploration of Patient Navigation and Community Health Worker Activities Across National Comprehensive Cancer Control Programs. [2020]

8. Trinidad and Tobago pubmed.ncbi.nlm.nih.gov

Impact of Delivering a Healthy Lifestyle Intervention: Promotora Findings from Familias Sanas y Activas II. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Establishing a health profession: What oncology patient navigators can learn from the National Association of Community Health Workers. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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

11. Australia pubmed.ncbi.nlm.nih.gov

Evolution of a health navigator model of care within a primary care setting: a case study. [2013]