Program in Oncology for Tribal Health Systems.
Part of paid clinical trials in Oklahoma City, Oklahoma.
- Sponsor
- University of Oklahoma
- Study ID
- NCT07217574
- Status
- Recruiting
Conditions
- Patient Outcomes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- C3PO — OTHERParticipants 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.
Study Details
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.
Key Dates
- Start date
- Feb 11, 2026
- Status verified
- Jun 2026
- Primary completion
- Mar 31, 2030
- Completion
- Mar 31, 2031
Study Design
- Enrollment
- 187 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Open Pilot StudyDuring 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
- Experimental: C3PO InterventionIn 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,.
- Active Comparator: Usual CarePatients 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.
Primary Outcome Measure
Perceptions of Cancer Care Coordination Needs [ Time Frame: 1 year ]
Central Contacts
- Amanda Janitz, Ph.D.405-271-2229
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | 73117 | Amanda Janitz, Ph.D. |
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