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 — OTHER
    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.

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 Study
    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
  • Experimental: C3PO Intervention
    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,.
  • Active Comparator: Usual Care
    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.

Primary Outcome Measure

Perceptions of Cancer Care Coordination Needs [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73117
Amanda Janitz, Ph.D.

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