Program in Oncology for Tribal Health Systems.

NCT07217574 | Recruiting

• 2 other identifiers: Tribal Health C3POU19MD020537
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

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

Keywords

American Indian (AI); American Native (AN)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Secondary Outcomes (2)

• Number of Missed Visits

  2 years

• Time from Diagnosis to Initial Treatment

  3 years

Other Outcomes (2)

• Treatment Interruptions

  4 year

• Treatment Intensity

  4 year

Study Arms (3)

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

Other: C3PO

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,.

Other: C3PO

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.

Other: C3PO

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.

C3PO Intervention; Open Pilot Study; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include all race and ethnic groups for staff interviews. Patient interviews and surveys will be restricted to American Indian/American Native patients.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Oklahoma: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

Study Officials

• Amanda Janitz, Ph.D.

  University of Oklahoma Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Janitz, Ph.D.

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 16, 2025
• Study Start: February 11, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)