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Recruiting

NCT Number: NCT07217574

Program in Oncology for Tribal Health Systems.

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.

Recruiting

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Key information

Conditions

Patient Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

Location status: Recruiting

Location contact

Amanda Janitz, Ph.D.

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Perceptions of Cancer Care Coordination Needs

    Time frame: 1 year

    All participants will complete the Patient Satisfaction with Cancer Care (PSCC) at baseline and monthly during the study duration.

Secondary outcomes

  1. Number of Missed Visits

    Time frame: 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.

  2. Time from Diagnosis to Initial Treatment

    Time frame: 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.

Other outcomes

  1. Treatment Interruptions

    Time frame: 4 year

    For treatment alignment, we will assess for alignment between treatment recommended and fitness (measured as met vs. not met) and alignment between treatment received and recommended (measured as met vs. not met). Alignment between fitness and treatment will be assessed using National Comprehensive Cancer Network (NCCN) recommendations and agreed upon by the physicians.

  2. Treatment Intensity

    Time frame: 4 year

    For treatment intensity, we will evaluate relative dose intensity defined as the ratio of the total dose of treatment actually delivered relative to the standard treatment dose. Doses of treatments will be captured for initial treatment and characterized as full dose vs. dose reduced. For complications, the treatment modifications (dose reductions and delays) will be abstracted for medical therapies.

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Janitz, Ph.D.

CONTACT

[email protected]

405-271-2229 ext. 48081

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Care Coordination and Communication Program in Oncology for Tribal Health Systems (C3PO)

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Oct 16, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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