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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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⁃ 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.

Locations
United States
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Contact Information
Primary
Mireille Leone
Mireille_Leone@med.unc.edu
919-445-0768
Backup
Onoshoze Bossey
obossey@email.unc.edu
(919)-445-4941
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2031-07-01
Participants
Target number of participants: 686
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: UNC Lineberger Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov