Program in Oncology for Tribal Health Systems.
ConditionPatient Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Participants in the Phase 1 open pilot will not be eligible for the Phase 2 RCT.
Trial design
Design model
Single group
Treatments tested in this trial
C3PO
Other interventionParticipants 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.
Treatment groups
187 Participants
are divided into 3 treatment groupsGroup A: Open Pilot StudyExperimental treatment 1 intervention
Group B: C3PO InterventionExperimental treatment 1 intervention
Group C: Usual CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
1 yearSecondary outcomes
1
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.
Time frame
2 years2
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.
Time frame
3 yearsOther outcomes
1
Treatment Interruptions
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.
Time frame
4 year2
Treatment Intensity
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.
Time frame
4 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oklahoma
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov