Effectiveness of Central Oncology Navigation and the Use of an ORN

UNC Lineberger Comprehensive Cancer Center

Status: Enrolling

Conditions: Malignant Tumor; Cancer

Treatments: Behavioral: Central oncology navigation (SOC); Behavioral: Intervention of oncology research navigator embedded in central oncology navigation

Study type: Interventional

Funder types: Other

Identifiers

NCT06618274

LCCC2334

Details and patient eligibility

About

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.

Enrollment: 686 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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686 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Behavioral: Central oncology navigation (SOC)

Cohort 2

Experimental group

Description:

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.

Treatment:

Behavioral: Intervention of oncology research navigator embedded in central oncology navigation