Oncology Navigation for Cancer

Overseen By Mireille Leone

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Lack of internet, English language, others

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

Compensation: Varies

Number of Visits: Unknown

686 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of cancer care support services by testing two different approaches. One group of patients with genitourinary or thoracic cancers will receive the standard central oncology navigation program. Another group, with gastrointestinal, hematology, or breast cancers, will receive additional support from an Oncology Research Navigator to assist in accessing care and clinical trials. Researchers aim to determine if this extra support enhances patients' quality of life and involvement in their treatment. Individuals with a new cancer diagnosis and an appointment at a UNC Medical Center may be suitable for this study. As an unphased trial, this study offers a unique opportunity to enhance the cancer care experience and potentially improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this oncology navigation method is safe?

Research has shown that patient navigation programs, such as the central oncology navigation under study, are generally safe and well-received. These programs guide patients through cancer treatment, improving patient satisfaction and access to care. A review of studies has demonstrated that these programs can reduce disparities in cancer care without causing harm.

The role of the oncology research navigator, an additional support in this study, has also been examined. Studies indicate that these navigators help manage symptoms and prevent unnecessary emergency room visits. This suggests that having an oncology research navigator is both helpful and safe for patients.

Overall, both the central oncology navigation and the addition of the oncology research navigator are well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the central oncology navigation program because it aims to streamline cancer care by providing patients with a dedicated support system throughout their treatment journey. Unlike traditional approaches, where patients might navigate their care independently, this program offers personalized guidance and coordination, potentially reducing stress and improving outcomes. By integrating a central navigator, patients can receive timely information, assistance with appointments, and support in understanding their treatment plans, which may lead to a more efficient and patient-centered healthcare experience.

What evidence suggests that this trial's treatments could be effective for cancer care?

This trial will compare two approaches to oncology navigation. Studies have shown that a central guide for cancer care can help patients access treatment more easily, particularly those facing barriers to care. Participants in Cohort 1 will attend clinics without the central navigation program. In contrast, Cohort 2 participants will be in clinics with the program and will be randomized to receive either standard care, which includes central oncology navigation, or the intervention of an oncology research navigator in addition to standard care. Research indicates that these programs can help patients begin treatments sooner and adhere to their treatment plans more effectively. Furthermore, a research-specific guide can encourage more patients to use supportive care services and join clinical trials, leading to better overall experiences and outcomes. Together, these approaches aim to make cancer care more efficient and supportive. ^{1 2 5 6 7}

Who Is on the Research Team?

William A Wood, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with new cancer appointments in genitourinary, thoracic, gastrointestinal, hematology, or breast cancers. It's designed to see if having a special guide called an 'oncology research navigator' (ORN) along with standard central oncology navigation helps improve their care. The study excludes details on specific inclusion and exclusion criteria.

Inclusion Criteria

Informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

I am willing and able to follow the study's requirements.

I have a confirmed cancer diagnosis and a new patient appointment at UNC Medical Center.

Exclusion Criteria

I cannot understand English.

Psychological or other disability resulting in the inability to provide informed consent

Lack of internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive central oncology navigation alone or with an oncology research navigator (ORN) for 3 months

12 weeks

Baseline and biweekly follow-up

Follow-up

Participants are monitored for quality of life, patient activation, and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Central Oncology Navigation
• Intervention of Oncology Research Navigator

Trial Overview The study tests the effectiveness of standard central oncology navigation alone versus adding an ORN to it. Patients are divided into two groups: one receives just the usual support while the other also gets help from an ORN who assists with clinical trials and supportive care services over three months.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

Cohort 2 will enroll participants with new cancer appointments within gastrointestinal (GI), hematology, and breast cancer (clinics where the central navigation program was implemented). These individuals will be randomized to receive standard of care, which for these cancer types includes central oncology navigation or the intervention of oncology research navigator in addition to SOC.

Group II: Cohort 1 Experimental Treatment 1 Intervention

Cohort 1 will enroll patients with new cancer appointments within genitourinary (GU) or thoracic cancers. These clinics have not yet implemented the central navigation program.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

Oncology nurse navigation programs significantly reduced the time from the first provider visit to the start of therapy for patients with hematologic malignancies, improving access to care.

Patient and provider satisfaction scores were high regarding the navigation program, although it did not lead to an increase in clinical trial enrollment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . Gordils-Perez, J., Schneider, SM., Gabel, M., et al.[2018]

A new screening tool was developed to identify adverse events (AEs) in cancer care, consisting of 76 specific triggers that can help detect potential safety issues during treatment.

This tool, which categorizes triggers related to general care, vital signs, medications, and laboratory tests, has the potential to improve patient safety and quality of care in oncology, although further testing is needed to validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. Lipitz-Snyderman, A., Weingart, SN., Anderson, C., et al.[2021]

Navigation programs in oncology significantly improve outcomes for cancer patients by reducing the time it takes to receive a diagnosis and treatment, while also enhancing knowledge and adherence to care among patients and caregivers.

These programs not only benefit patients but also healthcare institutions by lowering costs associated with emergency visits and readmissions, indicating a positive impact on overall healthcare efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of the Oncology Nurse Navigator Throughout the Cancer Trajectory. [2019]

Patient navigation (PN) significantly increases patient satisfaction with cancer care according to a randomized controlled trial, showing a large effect size (SMD = 2.30), indicating its potential effectiveness in improving patient experiences.

However, non-randomized studies did not find a significant association between PN and satisfaction, suggesting that the quality of the study design may influence the perceived effectiveness of PN in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of patient navigation on satisfaction with cancer care: a systematic review and meta-analysis. Wells, KJ., Campbell, K., Kumar, A., et al.[2019]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

The eRAPID system allows cancer patients to securely report adverse events (AEs) online during treatment, providing real-time data to clinicians and immediate self-management advice for different severity levels of AEs.

A randomized controlled trial is currently evaluating the effectiveness of eRAPID in improving AE reporting and management among breast, gynecological, and colorectal cancer patients, with adaptations being tested for other treatment groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an integrated electronic platform for patient self-report and management of adverse events during cancer treatment. Holch, P., Warrington, L., Bamforth, LCA., et al.[2022]

Nurse navigation in cancer care has been associated with significant improvements in clinical outcomes, including reduced distress, anxiety, and depression among patients.

Patients receiving nurse navigation experienced better symptom management, improved physical conditioning, enhanced quality of life, and quicker initiation of treatment, highlighting the effectiveness of this approach in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. Rodrigues, RL., Schneider, F., Kalinke, LP., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06618274

Effectiveness of Central Oncology Navigation and the Use ... This health services interventional study investigates the effectiveness of central oncology navigation (SOC ) alone and central oncology navigation with a new ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11063100/

Patient Navigation in Cancer Treatment: A Systematic Review The findings suggest that patient navigation plays a crucial role in improving access to care and optimizing treatment outcomes, especially for disadvantaged ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP-25-00020

Validating Navigation as Essential Care in Modern Oncology Randomized trial of enhanced versus standard navigation to promote timely initiation of adjuvant radiotherapy for head and neck cancer.

4. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella ...

5. oncologynurseadvisor.com oncologynurseadvisor.com/reports/strengthening-oncology-patient-navigation-enhances-outcomes-treatment/

Strengthening Oncology Patient Navigation Enhances ... Patient navigation plays a critical role in reducing cancer disparities and improving outcomes by addressing barriers to care, coordinating services,

6. ons.org ons.org/network-advocacy/position-statements/role-oncology-nurse-navigator-throughout-cancer-trajectory

Role of the Oncology Nurse Navigator Throughout ... Navigation in oncology has long demonstrated benefits for people at risk for or diagnosed with cancer. These include a shorter time to diagnosis and start of ...

7. prescancerpanel.cancer.gov prescancerpanel.cancer.gov/reports-meetings/enhancing-patient-navigation-2024/executive-summary

Executive Summary - Enhancing Patient Navigation with ... Patient navigation has been proven to reduce cancer disparities—a critical problem facing the National Cancer Program—by addressing individual ...