An interventional study of C3PO in Patient Outcomes, sponsored by University of Oklahoma. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Oklahoma · Not applicable, Interventional, and Supportive care
This clinical trial aims to develop and implement more navigation assistance programs tailored specifically for Native American cancer patients, addressing the current lack of available support. The goal is to improve communication barriers within the healthcare system by fostering a collaborative approach between the Stephenson Cancer Center (SCC) and tribally operated healthcare systems (ITU). Through this partnership, the trial seeks to enhance patient outcomes by providing culturally sensitive, coordinated care.
This study aims to evaluate the impact of collaborative care meetings (CCM) on patient-reported outcomes through a two-phase approach including Native American patients with cancer. Phase I is a 3-month pilot with up to 15 patients completing baseline assessments, monthly surveys, and exit interviews. Phase II is a randomized controlled trial (RCT) comparing the Care Coordination and Communication Program in Oncology for Tribal Health Systems (C3PO) intervention to usual care (standard Native American navigation services), with all participants accessing the C3PO intervention after 6 months. C3PO meetings will address treatment side effects, comorbidities, approvals for referred care, and barriers such as transportation or financial hardship.
University of Oklahoma is the lead sponsor of 424 studies on the registry; 99 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
During the open pilot study, which will take place over a 3-month period, up to 15 patients will be enrolled to receive the C3PO intervention. At the conclusion of this period, exit interviews will be conducted to gather feedback on the implementation of the intervention. The primary objective of this phase is to assess the strengths and weaknesses of the intervention in order to inform potential improvements before advancing to the next phase of the study
Other: C3PO
In Phase II of the study, patients will be randomized 1:1 by site and cancer type to either the C3PO intervention group or the usual care group. Those assigned to the C3PO arm will receive navigation services at SCC, along side collaborative care meetings (C3PO). These meetings, held without the patient present, will focus on discussing the patient's overall needs, such as potential adverse effects of cancer treatment, the impact of co-morbid conditions, etc,.
Other: C3PO
Patients randomized to the usual care group will receive navigation services only and will not participate in the C3PO intervention during the initial 6 months. However, after this 6-month period, they will become eligible to receive the C3PO intervention, following the same process as the initial intervention group.
Other: C3PO
Participants assigned to C3PO will receive usual navigation services with a Native American Navigator (NAN) at the SCC but will begin having their clinical care and social needs discussed during monthly collaborative care meetings. For the Open Pilot, this will include all participants (no randomization or usual care group). The collaborative care coordinator will meet with the participant virtually or in-person before and after collaborative care meetings as they are available and as needs arise.
Perceptions of Cancer Care Coordination Needs
All participants will complete the Patient Satisfaction with Cancer Care (PSCC) at baseline and monthly during the study duration.
Time frame: 1 year
Number of Missed Visits
Completed and all missed visits will be recorded in SCC's appointment database, which will be queried via the institutional software. The NANP cohort will be run through this query monthly to identify missed oncology visits, and the information will be entered into the NANP database. The proportion of missed visits for all navigated patients will be tallied monthly. Types of missed visits include no-show, canceled by SCC, rescheduled by pt, other, and unknown.
Time frame: 2 years
Time from Diagnosis to Initial Treatment
Using the EHR, in partnership with the OU Clinical Research Data Warehouse, we will calculate the average number of days from date of diagnosis to date of first treatment for existing and newly navigated patients.
Time frame: 3 years
Treatment Interruptions
For treatment alignment, we will assess for alignment between treatment recommended and fitness (measured as met vs. not met) and alignment between treatment received and recommended (measured as met vs. not met). Alignment between fitness and treatment will be assessed using National Comprehensive Cancer Network (NCCN) recommendations and agreed upon by the physicians.
Time frame: 4 year
Treatment Intensity
For treatment intensity, we will evaluate relative dose intensity defined as the ratio of the total dose of treatment actually delivered relative to the standard treatment dose. Doses of treatments will be captured for initial treatment and characterized as full dose vs. dose reduced. For complications, the treatment modifications (dose reductions and delays) will be abstracted for medical therapies.
Time frame: 4 year
Plan to share: No
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University of Oklahoma