NCT06618274 Effectiveness of Central Oncology Navigation and the Use of an ORN
| NCT ID | NCT06618274 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 686 participants |
| Start Date | 2025-03-03 |
| Primary Completion | 2027-01-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 686 participants in total. It began in 2025-03-03 with a primary completion date of 2027-01-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
William A Wood, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06618274 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06618274 currently recruiting?
Yes, NCT06618274 is actively recruiting participants. Contact the research team at Mireille_Leone@med.unc.edu for enrollment information.
Where is the NCT06618274 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06618274 clinical trial?
NCT06618274 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is William A Wood, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 686 participants.
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