Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT06618274Sponsor: UNC Lineberger Comprehensive Cancer CenterLast updated: 2026-01-28

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.

Arms & interventions

  • BehavioralIntervention 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.

  • BehavioralCentral oncology navigation (SOC)

    Central oncology navigation (SOC ) alone.

Outcome measures

Primary

  • 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.

    Time frame: 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.

    Time frame: Up to 6 months

Secondary

  • Cohort 1: Health-related quality of life

    Time frame: Baseline and 3 months

  • Cohort 1: Patient activation

    Time frame: Baseline and 3 months

  • Cohort 1: Patient experience

    Time frame: Baseline and 3 months

  • Cohort 1: Net promoter

    Time frame: Baseline and 3 months

  • Cohort 1: Overall Survival

    Time frame: Up to 5 years

  • Cohort 2: Health-related quality of life

    Time frame: Baseline and 3 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Recruiting
Onoshoze Bossey · Contact
William Wood, MD · Principal Investigator
Effectiveness of Central Oncology Navigation and the Use of an ORN | Cancerify