Patient OutcomesNCT07217574
Program in Oncology for Tribal Health Systems.
A study testing C3PO in people with Patient Outcomes, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Outcomes
- What is being tested?
- C3PO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2026to Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants in the Phase 1 open pilot will not be eligible for the Phase 2 RCT.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Amanda Janitz, Ph.D., Amanda-Janitz@ouhsc.edu
About this study
Official title: Care Coordination and Communication Program in Oncology for Tribal Health Systems (C3PO)
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.
Read the 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.
- Conditions
- Patient Outcomes
- Being tested
- C3PO
- Keywords
- American Indian (AI), American Native (AN)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C3POOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Open Pilot Study | Experimental | 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 Receives: Other: C3PO |
| C3PO Intervention | Experimental | In Phase II of the study, patients will be randomized 1:1 by site 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. Receives: Other: C3PO |
| Usual Care | Active comparator | Patients randomized to the usual care group will receive navigation services only and will not participate in the C3PO intervention during the initial 3 months. However, after this 3-month period, they will become eligible to receive the C3PO intervention, following the same process as the initial intervention group. Receives: Other: C3PO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (2)
Number of Missed Visits
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.
Measured: 2 years
Time from Diagnosis to Initial Treatment
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start11 Feb 2026
- Primary completionMar 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 187 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Amanda Janitz, Ph.D., Principal investigator, University of Oklahoma Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217574
- Sponsor's protocol ID
- Tribal Health C3PO (Pilot)
- Other IDs
- U19MD020537
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Coordination and Communication Program in Oncology for Tribal Health Systems (C3PO)
- ClinicalTrials.gov ID
- NCT07217574
- Acronym / sponsor ID
- Tribal Health C3PO (Pilot)
- Conditions
- Patient Outcomes
- Keywords
- American Indian (AI), American Native (AN)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 187 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 16 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Pilot Study | Experimental | Other: C3PODuring 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 |
| C3PO Intervention | Experimental | Other: C3POIn Phase II of the study, patients will be randomized 1:1 by site 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. |
| Usual Care | Active comparator | Other: C3POPatients randomized to the usual care group will receive navigation services only and will not participate in the C3PO intervention during the initial 3 months. However, after this 3-month period, they will become eligible to receive the C3PO intervention, following the same process as the initial intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Participants in the Phase 1 open pilot will not be eligible for the Phase 2 RCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C3POParticipants 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. | Other | C3PO Intervention, Open Pilot Study, Usual Care |
Primary outcome
Perceptions of Cancer Care Coordination Needs
Time frame: Six months
All participants will complete the Patient Satisfaction with Cancer Care (PSCC) at baseline and monthly during the study duration.
2 secondary outcomes
Number of Missed Visits
Time frame: 2 years
Time from Diagnosis to Initial Treatment
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Janitz, Ph.D. principal investigator
University of Oklahoma Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C3PO in people with Patient Outcomes, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amanda Janitz, Ph.D. (405-271-2229 ext. 48081, Amanda-Janitz@ou.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptions of Cancer Care Coordination Needs (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.