[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07217574":3,"trial-entities:NCT07217574":90,"trial-summary:NCT07217574":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":38,"secondary_outcomes":43,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":61,"locations":64,"central_contacts":79,"overall_officials":84,"references":88,"see_also_links":89},"NCT07217574","Tribal Health C3PO","Program in Oncology for Tribal Health Systems.","Care Coordination and Communication Program in Oncology for Tribal Health Systems (C3PO)","RECRUITING","2031-03","2026-06","2026-06-11","2026-02-11","University of Oklahoma","OTHER",false,"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.","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.",[19],"Patient Outcomes",[21,22],"American Indian (AI)","American Native (AN)","INTERVENTIONAL","SUPPORTIVE_CARE",[26],"NA",{"count":28,"type":29},187,"ESTIMATED",[31],{"type":14,"name":32,"description":33,"armGroupLabels":34},"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 arise.",[35,36,37],"C3PO Intervention","Open Pilot Study","Usual Care",[39],{"measure":40,"description":41,"timeFrame":42},"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.","1 year",[44,48],{"measure":45,"description":46,"timeFrame":47},"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.","2 years",{"measure":49,"description":50,"timeFrame":51},"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.","3 years","ALL","18 Years",null,{"inclusion":56,"exclusion":58,"raw_text":60},[57],"Participants must be at least 18 years of age, within eight weeks of newly diagnosed cancer confirmed by pathology\u002Fimaging, navigated through the NANP at SCC and have verbal fluency in English.",[59],"Participants in the Phase 1 open pilot will not be eligible for the Phase 2 RCT.","Inclusion Criteria:\n\n* Participants must be at least 18 years of age, within eight weeks of newly diagnosed cancer confirmed by pathology\u002Fimaging, navigated through the NANP at SCC and have verbal fluency in English.\n\nExclusion Criteria:\n\n* Participants in the Phase 1 open pilot will not be eligible for the Phase 2 RCT.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":66,"status":8,"city":67,"state":68,"zip":69,"country":70,"contacts":71,"geoPoint":76},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73117","United States",[72],{"name":73,"role":74,"email":75},"Amanda Janitz, Ph.D.","CONTACT","Amanda-Janitz@ouhsc.edu",{"lat":77,"lon":78},35.46756,-97.51643,[80],{"name":73,"role":74,"phone":81,"phoneExt":82,"email":83},"405-271-2229","48081","Amanda-Janitz@ou.edu",[85],{"name":73,"affiliation":86,"role":87},"University of Oklahoma Stephenson Cancer Center","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Malignant Neoplasm",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This study has two phases, starting with a pilot phase for up to 15 patients, followed by a randomized controlled trial (RCT) involving 187 participants. In the RCT, some participants will receive C3PO, while others will receive standard navigation services, with all participants eventually accessing C3PO after 6 months.","completed","Improving Cancer Care for Native American Patients","This study, called the Program in Oncology for Tribal Health Systems, is testing a new way to help Native American cancer patients. It's called C3PO, and it adds monthly team meetings to the usual navigation services you might receive. These meetings bring together healthcare providers to discuss your clinical care and social needs. The goal is to improve how well your cancer care is coordinated and to address any communication barriers. You might be able to join if you are at least 18 years old, have a new cancer diagnosis within the last eight weeks, are navigated through the Native American Navigator Program (NANP) at Stephenson Cancer Center (SCC), and speak English. The study will look at your perceptions of cancer care coordination needs after one year. The current status of this study is unclear.","Your perceptions of cancer care coordination needs will be measured at 1 year.",135,"If you join, you will complete baseline assessments, monthly surveys, and exit interviews. The C3PO meetings will discuss treatment side effects, other health conditions, approvals for referred care, and barriers like transportation or financial issues.","Not stated in the trial record.",[32],"v2"]