Navigation and Research: Evaluating the Intervention of Central Navigation and an Oncology Research Navigator (ORN) on Cancer Outcomes and Clinical Trial Enrollment (NAVIGATE Trial)
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
Study locations (1)
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599