Effectiveness of Central Oncology Navigation and the Use of an ORN (NCT06618274)
Navigation and Research: Evaluating the Intervention of Central Navigation and an Oncology Research Navigator (ORN) on Cancer Outcomes and Clinical Trial Enrollment (NAVIGATE Trial)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
Age range: 18 Years
🧪 Interventions in This Study
- Intervention of oncology research navigator embedded in central oncology navigation (BEHAVIORAL)
- Central oncology navigation (SOC) (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina
📞 Contact the Study Coordinator
Phone: (919) 445-0768
Email: Mireille_Leone@med.unc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.