Recruiting

Observational Study

Sponsor:

University of Oklahoma

Code:

NCT07217574

Conditions

Patient Outcomes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

C3PO

Study Details

Brief summary:

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.

Conditions

Patient Outcomes

Study ID

NCT07217574

Start date

Feb 11, 2026

Status verified date

Jun, 2026

Completion date

Mar, 2031

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must be at least 18 years of age, within eight weeks of newly diagnosed cancer confirmed by pathology/imaging, navigated through the NANP at SCC and have verbal fluency in English.

Exclusion Criteria:

  • Participants in the Phase 1 open pilot will not be eligible for the Phase 2 RCT.

Study Design

Enrollment

187 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Amanda Janitz, Ph.D.

405-271-2229Amanda-Janitz@ou.edu

Locations

OU Health Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73117

Contacts

Amanda Janitz, Ph.D.

Amanda-Janitz@ouhsc.edu

More Information

Sponsor

University of Oklahoma

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • American Indian (AI)
  • American Native (AN)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-06-11.