This clinical trial tests how well central oncology navigation and an oncology research navigator (ORN) works in improving participation in supportive care services and enrollment in non-treatment clinical trials in patients with cancer. Central oncology navigation is a team that interacts with patients to help patients know about services that may benefit them. Supportive care services may include counseling, nutrition and health coaching, physical activity, and caregiving programs, among other services. An ORN interacts with patients to provide information about available clinical trials for patient participation. Clinical trials are a type of research study that test how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease. Using central oncology navigation and an ORN may help cancer patients participate in supportive care services and enroll in non-treatment clinical trials.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06618274.
Locations matching your search criteria
United States
North Carolina
Chapel Hill
UNC Lineberger Comprehensive Cancer CenterStatus: Active
Contact: William Allen Wood
Phone: 984-974-8349
PRIMARY OBJECTIVES:
I. To evaluate whether use of supportive care services increases with implementation of central oncology navigation. (Cohort 1)
II. To evaluate whether enrollment into non-treatment clinical trials is higher with an ORN intervention. (Cohort 2)
SECONDARY OBJECTIVES:
I. To compare health-related quality of life between groups. (Cohort 1)
II. To compare patient activation between groups. (Cohort 1)
III. To compare patient experience between groups. (Cohort 1)
IV. To compare net promoter scores between groups. (Cohort 1)
V. To compare overall survival between groups. (Cohort 1)
VI. To compare health-related quality of life between groups. (Cohort 2)
VII. To compare patient activation between groups. (Cohort 2)
VIII. To compare patient experience between groups. (Cohort 2)
IX. To compare net promoter scores between groups. (Cohort 2)
X. To compare overall survival between groups. (Cohort 2)
EXPLORATORY OBJECTIVES:
I. To compare enrollment into non-treatment clinical trials between groups at 6 months. (Cohort 1)
II. To compare enrollment into non-treatment clinical trials between groups at 12 months. (Cohort 1)
III. To compare enrollment into treatment trials between groups at 6 months. (Cohort 1)
IV. To compare enrollment into treatment trials between groups at 12 months. (Cohort 1)
V. To compare enrollment into non-treatment trials between groups at 12 months. (Cohort 2)
VI. To compare enrollment into treatment trials between groups at 6 months. (Cohort 2)
VII. To compare enrollment into treatment trials between groups at 12 months. (Cohort 2)
OUTLINE:
COHORT 1: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive standard of care (SOC) without a central oncology navigation team for 3 months on study.
GROUP II: Patients receive SOC with a central oncology navigation team for 3 months on study.
COHORT 2: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive SOC with a central oncology navigation team for 3 months on study.
GROUP II: Patients receive SOC with a central oncology navigation team and contacts from an ORN every 2 weeks (Q2W) for 3 months on study.
After completion of study intervention, patients are followed up for 5 years.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUNC Lineberger Comprehensive Cancer Center
Principal InvestigatorWilliam Allen Wood
