Program in Oncology for Tribal Health Systems.

Not yet recruiting

• Conditions: Patient Outcomes

• Registration Number: NCT07217574
• Lead Sponsor: University of Oklahoma

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2025-09-26
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-14
• Last Update Submitted: 2025-10-14
• Study First Posted: 2025-10-16
• Last Update Posted: 2025-10-16
• Study Start: 2025-11-01
• Primary Completion: 2030-11
• Study Completion: 2031-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 187

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perceptions of Cancer Care Coordination Needs	1 year	All participants will complete the Patient Satisfaction with Cancer Care (PSCC) at baseline and monthly during the study duration.

Secondary Outcome Measures

Name	Time	Method
Number of Missed Visits	2 years	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 from Diagnosis to Initial Treatment	3 years	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.

Trial Locations

Locations (1)

OU Health Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States