Patient Outcomes
Conditions
Keywords
American Indian (AI), American Native (AN)
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.
Interventions
OTHERC3PO
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.
Sponsors
University of Oklahoma
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTAmanda Janitz, Ph.D.
PRINCIPAL_INVESTIGATORAmanda Janitz, Ph.D.
University of Oklahoma Stephenson Cancer Center
Outcome results
None listed