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Recruiting NCT07217574

Program in Oncology for Tribal Health Systems.

No phase Interventional Patient Outcomes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C3PO.
Who it may be relevant to
Registry conditions: Patient Outcomes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other 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 aris

Primary outcome measures

  • Perceptions of Cancer Care Coordination Needs [Time frame: 1 year]
Secondary outcome measures (2)
  • Number of Missed Visits [Time frame: 2 years]
  • Time from Diagnosis to Initial Treatment [Time frame: 3 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • OU Health Stephenson Cancer Center — Oklahoma City

Identifiers

NCT: NCT07217574 · Tribal Health C3PO · U19MD020537

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗