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

Trial Summary

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 data supports the effectiveness of the treatment Central Oncology Navigation?

Research shows that patient navigation, which helps guide patients through cancer care, can improve patient satisfaction and coordination of care. Additionally, a study found that a nurse navigator-led program improved treatment adherence and patient experience, reduced hospital stays, and decreased severe treatment-related side effects. ^{1 2 3 4 5}

Is Oncology Navigation for Cancer safe for humans?

Oncology Navigation, often performed by nurses, has shown benefits like better patient knowledge and quality of life, and reduced emergency visits, suggesting it is generally safe. However, specific safety data for this treatment under different names or conditions is not detailed in the available research. ^{4 6 7 8 9}

How is the Central Oncology Navigation treatment different from other cancer treatments?

Central Oncology Navigation is unique because it focuses on guiding patients through the complex healthcare system, helping them access the right treatments and support services, which is different from traditional treatments that directly target the cancer itself. ^{10 11 12 13 14}

What is the purpose of this trial?

This health services interventional study investigates the effectiveness of central oncology navigation (SOC ) alone and central oncology navigation with a new role called an "oncology research navigator (ORN)" who is embedded in central oncology navigation cancer care delivery. This study will examine two patient cohorts: 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. Participants will be enrolled pre- and post-implementation of the central oncology navigator within these cancer groups to evaluate the effectiveness of the central oncology navigator alone. The second cohort 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 an oncology research navigator in addition to SOC. This intervention will involve baseline and biweekly follow-up for a total of 3 months. Interactions with the ORN will include facilitating participation in supportive care services and clinical trials. All participants will undergo baseline and follow-up patient-reported outcomes and data collection. The study will evaluate the impact of the central oncology navigation program alone, as well as the addition of the ORN on patient quality of life, as well as enrollment into studies and participation in supportive care services. Additional analyses will evaluate the impact of the central oncology navigation program on patient experience, patient activation, net promoter scores, and overall survival.

Research Team

William A Wood, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Oncology Nurse Navigation: Development and Implementation of a Program at a Comprehensive Cancer Center . [2018]

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

Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Effects of patient navigation on satisfaction with cancer care: a systematic review and meta-analysis. [2019]

4. Brazil pubmed.ncbi.nlm.nih.gov

Clinical outcomes of patient navigation performed by nurses in the oncology setting: an integrative review. [2022]

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

Predictors of resolution in navigated patients with abnormal cancer screening tests. [2018]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Development of an integrated electronic platform for patient self-report and management of adverse events during cancer treatment. [2022]

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

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

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

ReCAP: Detection of Potentially Avoidable Harm in Oncology From Patient Medical Records. [2021]

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

CNS metastasis: an old problem in a new guise. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Brain metastases as preventive and therapeutic targets. [2022]

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

A Brief Report of the Status of Central Nervous System Metastasis Enrollment Criteria for Advanced Non-Small Cell Lung Cancer Clinical Trials: A Review of the ClinicalTrials.gov Trial Registry. [2017]

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

Management Paradigm of Central Nervous System Metastases in NSCLC: An Australian Perspective. [2023]

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

Modern Management of Central Nervous System Metastases in the Era of Targeted Therapy and Immune Oncology. [2021]