NCT07332312

A Culturally Informed Patient Navigation Program (CFPN) to Reduce Delays Between Diagnosis and Treatment in American Indian and Alaska Native Cancer Patients Living in Rural California

Developing a Culturally Informed Patient Navigation Program to Reduce Delays From Diagnosis to Treatment for Native Americans in a Rural Setting

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This clinical trial develops and tests whether a culturally informed patient navigation program, Community-Focused Patient Navigation (CFPN), works to reduce delays between diagnosis and treatment in American Indian and Alaska Native (AIAN) cancer patients living in rural California. AIAN communities face some of the most severe cancer disparities in the United States, including higher death rates, later-stage diagnoses, and limited access to timely, culturally responsive care. This may be due to barriers such as rural isolation, divided referral systems, or a lack of trust in mainstream healthcare systems. Patient navigation is a care delivery model designed to guide a patient through the healthcare system and address the barriers that prevent patients from accessing timely and effective care. The CFPN program is culturally tailored and designed with AIAN communities in mind. The program provides the patient with a treatment plan based on the patient's unique needs, goals, and barriers. This may be an effective way to reduce delays between diagnosis and treatment in AIAN cancer patients living in rural California.

Detailed description

PRIMARY OBJECTIVES: I. Conduct a comprehensive community-informed planning process to co-design the Community-Focused Patient Navigation (CFPN) program. II. Develop and implement an evidence and practice-informed, culturally responsive, CFPN program. III. Evaluate the implementation and impact of the CFPN program using Practical, Robust Implementation and Sustainability Model (PRISM) and the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) frameworks, along with Indigenous evaluation practices. OUTLINE: Participants are assigned to 1 of 2 objectives. OBJECTIVE 1: Participants are assigned to 1 of 3 groups. GROUP I: Participants serve on a Community Advisory Board (CAB) to guide the co-design process of the CFPN program on study. GROUP II: Participants complete a focus group over 1-2 hours in support of the co-design process of the CFPN program on study. GROUP III: Participants complete a key informant interview (KII) over 30 minutes in support of the co-design process of the CFPN program on study. OBJECTIVE 2: Patients engage with the CFPN program navigator as needed and receive a treatment plan based on the patient's needs, goals, and barriers on study. Patients also receive opioid misuse education and care coordination on study.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

Type	Name	Description
OTHER	Discussion	Serve on CAB
OTHER	Discussion	Complete focus group
OTHER	Educational Intervention	Receive opioid misuse education and care coordination
OTHER	Electronic Health Record Review	Ancillary studies
OTHER	Interview	Complete KII
OTHER	Interview	Ancillary studies
BEHAVIORAL	Patient Navigation	Engage with CFPN program navigator
OTHER	Survey Administration	Ancillary studies
PROCEDURE	Tailored Intervention	Receive treatment plan

Timeline

• Start date: 2026-06-30
• Primary completion: 2027-11-13
• Completion: 2028-11-13
• First posted: 2026-01-12
• Last updated: 2026-03-16

Locations

2 sites across 1 country: United States