Effectiveness of Central Oncology Navigation and the Use of an ORN

Navigation and Research: Evaluating the Intervention of Central Navigation and an Oncology Research Navigator (ORN) on Cancer Outcomes and Clinical Trial Enrollment (NAVIGATE 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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Malignant Tumor
• Intervention / Treatment: Behavioral: Central oncology navigation (SOC); Behavioral: Intervention of oncology research navigator embedded in central oncology navigation

• Study Type: Interventional
• Enrollment (Estimated): 686
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mireille Leone; Phone Number: 919-445-0768; Email: Mireille_Leone@med.unc.edu
• Study Contact Backup: Name: Allison Ross; Phone Number: (919)-445-4941; Email: Allison_Ross@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • UNC Lineberger Comprehensive Cancer Center
      • Contact: Onoshoze Bossey; Phone Number: 919-445-4941; Email: onoshoze_bossey@med.unc.edu
      • Principal Investigator: William Wood, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

• Informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Subject is willing and able to comply with study activities based on the judgement of the investigator.
• Age ≥ 18 years at the time of consent.
• Subject has a new patient appointment for cancer care at a UNC Medical Center and a confirmed cancer diagnosis.

Exclusion Criteria:

• Lack of internet access.
• Inability to understand the English language.
• Psychological or other disability resulting in the inability to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1; 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.	Behavioral: Central oncology navigation (SOC); Central oncology navigation (SOC ) alone.
Experimental: Cohort 2; 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.	Behavioral: Intervention of oncology research navigator embedded in central oncology navigation; The intervention of oncology research navigator or Oncology research navigator (ORN) is embedded in central oncology navigation cancer care delivery.; Other Names: oncology research navigator (ORN

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1-supportive service offered	Participation in at least 1 supportive service offered will be measured by the number of patients receiving services. This information will be gathered from chart review.	Up to 6 months
Cohort 2: number of patients enrolled	Enrollment into non-treatment clinical studies will be measured by the number of patients enrolled at any time. This information will be gathered from chart review.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cohort 1: Health-related quality of life	Cohort 1: Health-related quality of life will be measured using the PROMIS Global Health. The PROMIS Global Health is a comprehensive tool designed to assess an individual's overall physical, mental, and social health and includes 10 items that cover various health domains. These items are divided into two main components: Global Physical Health and Global Mental Health. Global Physical Health: This includes items related to physical functioning, pain, fatigue, and overall physical health. Global Mental Health: This includes items related to mental health, emotional distress, and social health.Response Options: Each item is rated on a 5-point Likert scale, with higher scores indicating better health.Raw Scores: The responses are summed to create raw scores for both the Global Physical Health and Global Mental Health components.	Baseline and 3 months
Cohort 1: Patient activation	Cohort 1: Patient activation will be measured using Patient Activation Measure -13 (PAM-13). PAM-13 is a validated questionnaire designed to assess an individual's knowledge, skills, and confidence in managing their own health and healthcare. It consists of 13 items that measure patient activation, which is the extent to which individuals feel capable of managing their health. The PAM 13 includes 13 statements that respondents rate based on their level of agreement, ranging from "Strongly Disagree" to "Strongly Agree." Responses are scored on a scale from 0 to 100. Higher scores indicate greater patient activation.	Baseline and 3 months
Cohort 1: Patient experience	Cohort 1: Patient experience will be measured using the Consumer Assessment of Healthcare Providers and Systems (CAHPs) cancer care survey. Scoring will be any number from 0 to 10, where 0 is the worst cancer care team possible and 10 is the best cancer care team possible, what number would you use to rate your cancer care team? (0-10 rating, from "worst cancer care team possible" to "best cancer care team possible" 2. Considering all your cancer care at this cancer center, using any number from 0 to 10, where 0 is the worst overall cancer care experience possible and 10 is the best overall cancer care experience possible, what number would you use to rate your overall cancer care experience? (0-10 rating, from "worst overall cancer care experience possible" to "best overall cancer care experience possible")	Baseline and 3 months
Cohort 1: Net promoter	Cohort 1: Net promoter scores will be measured using the net promoter score survey. The Net Promoter Score (NPS) is used as a metric for assessing customer loyalty and satisfaction. NPS measures the likelihood of customers to recommend a company's product or service to others. It is based on a single question: "On a scale from 0 to 10, how likely are you to recommend our product/service to a friend or colleague?"	Baseline and 3 months
Cohort 1: Overall Survival	Cohort 1: Overall Survival, defined as death by any cause from the time of enrollment will be measured. Any patient who has not died by the analysis date will be censored. Sub-analyses for cancer types will be conducted.	Up to 5 years
Cohort 2: Health-related quality of life	Cohort 2: Health-related quality of life will be measured using the PROMIS Global Health 10-item instrument in all participants The PROMIS Global Health is a comprehensive tool designed to assess an individual's overall physical, mental, and social health and includes 10 items that cover various health domains. These items are divided into two main components: Global Physical Health and Global Mental Health. Global Physical Health: This includes items related to physical functioning, pain, fatigue, and overall physical health. Global Mental Health: This includes items related to mental health, emotional distress, and social health.Response Options: Each item is rated on a 5-point Likert scale, with higher scores indicating better health.Raw Scores: The responses are summed to create raw scores for both the Global Physical Health and Global Mental Health components.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: William A Wood, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): January 10, 2027
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: September 25, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): January 28, 2026
• Last Update Submitted That Met QC Criteria: January 26, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: navigation
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LCCC2334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No