Clinical trial NCT06618274: Effectiveness of Central Oncology Navigation and the Use of an ORN
Official title: Navigation and Research: Evaluating the Intervention of Central Navigation and an Oncology Research Navigator (ORN) on Cancer Outcomes and Clinical Trial Enrollment (NAVIGATE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Malignant Tumor
Keywords: navigation
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 686
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Cohort 1-supportive service offered
timeFrame: Up to 6 months
measure: Cohort 2: number of patients enrolled
timeFrame: Up to 6 months
Secondary outcomes:
measure: Cohort 1: Health-related quality of life
timeFrame: Baseline and 3 months
measure: Cohort 1: Patient activation
timeFrame: Baseline and 3 months
measure: Cohort 1: Patient experience
timeFrame: Baseline and 3 months
measure: Cohort 1: Net promoter
timeFrame: Baseline and 3 months
measure: Cohort 1: Overall Survival
timeFrame: Up to 5 years
measure: Cohort 2: Health-related quality of life
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: William A Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: