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

May 7, 2026 updated by: University of Southern California

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Bishop, California, United States, 93514
        • Recruiting
        • Toiyabe Indian Health Project
        • Principal Investigator:
          • Tina Cassar
        • Contact:
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC / Norris Comprehensive Cancer Center
        • Contact:
          • Claradina Soto
          • Phone Number: 323-442-8219
          • Email: toya@usc.edu
        • Principal Investigator:
          • Claradina Soto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • CAB: Self-identify as AIAN or have experience working with the AIAN community
  • CAB: Are 18 years or older
  • CAB: Live within Toiyabe Indian Health Program (TIHP) catchment area(s)
  • CAB: Are either a cancer patient/survivor/caregiver and/or a family member of an individual(s) affected by cancer, OR a Board member (ex: Tribal Health Board or Elders Board)
  • FOCUS GROUP: Self-identify as AIAN or a family member of an AIAN individual affected by cancer
  • FOCUS GROUP: Are 18 years or older
  • FOCUS GROUP: Live within TIHP catchment area(s)
  • FOCUS GROUP: Are either a cancer patient/survivor/caregiver and/or a family member of an individual(s) affected by cancer, OR a Board member (ex: Tribal Health Board or Elders Board)
  • KII: Be a TIHP healthcare staff member
  • KII: Be 18 years or older
  • KII: Work with AIAN cancer patients in TIHP catchment area
  • CFPN PROGRAM IMPLEMENTATION: Have any type of cancer, are in any treatment stage along the cancer continuum
  • CFPN PROGRAM IMPLEMENTATION: Self-identify as AIAN or be a TIHP patient
  • CFPN PROGRAM IMPLEMENTATION: Live in the TIHP service area
  • CFPN PROGRAM IMPLEMENTATION: Receive cancer-related services from TIHP

Exclusion Criteria:

  • FOCUS GROUP: Individual with no experience with cancer either as a patient or know someone who is/was a cancer patient at TIHP
  • CFPN PROGRAM IMPLEMENTATION: Not a TIHP patient
  • CFPN PROGRAM IMPLEMENTATION: Does not currently have cancer or has not previously had cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Objective 1 group I (CAB)
Participants serve on a CAB to guide the co-design process of the CFPN program on study.
Other: Discussion
Serve on CAB
Other Names:
  • Discuss
Other: Discussion
Complete focus group
Other Names:
  • Discuss
Other: Objective 1 group II (focus group)
Participants complete a focus group over 1-2 hours in support of the co-design process of the CFPN program on study.
Other: Discussion
Serve on CAB
Other Names:
  • Discuss
Other: Discussion
Complete focus group
Other Names:
  • Discuss
Other: Objective 1 group III (KII)
Participants complete a KII over 30 minutes in support of the co-design process of the CFPN program on study.
Other: Interview
Ancillary studies
Other: Interview
Complete KII
Experimental: Objective 2 (CFPN program)
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.
Other: Survey Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Electronic Health Record Review
Ancillary studies
Other: Interview
Complete KII
Other: Educational Intervention
Receive opioid misuse education and care coordination
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Behavioral: Patient Navigation
Engage with CFPN program navigator
Other Names:
  • Patient Navigator Program
Procedure: Tailored Intervention
Receive treatment plan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus group themes and emerging codes
Time Frame: Through study completion, up to 2 years
Will compare themes and emerging codes utilizing qualitative coding computer software. A report will summarize participant responses for each focus group and will be discussed with the Toiyabe Indian Health Program (THIP) co-principal investigator (Co-PI) and staff prior to sharing with the Community Advisory Board (CAB) members.
Through study completion, up to 2 years
Key informant interview findings and proposed strategies
Time Frame: Through study completion, up to 2 years
Will prepare a report with the findings and proposed strategies and discuss it with TIHP Co-PI and CAB.
Through study completion, up to 2 years
Qualitative Effectiveness of Community-Focused Patient Navigation (CFPN) program
Time Frame: Through study completion, up to 2 years
Data collected in interviews focusing on patient's cancer journey and experience with the CFPN program will be analyzed using Dedoose software and an inductive qualitative approach. Two-coder teams will code separately and discuss discrepancies and reconciliations, and the codes will be applied to transcripts and fieldnotes.
Through study completion, up to 2 years
Quantitative Effectiveness of Community-Focused Patient Navigation (CFPN) program
Time Frame: Through study completion, up to 2 years
Using Patient Satisfaction With Cancer Care Scale (Jean-Pierre, 2010) to collect data regarding the effectiveness of the CFPN program. Data will be analyzed using SAS to measure the unilateral satisfaction construct through descriptive statistics (e.g., means, medians, frequencies) and summarizing single-group satisfaction at post-intervention.
Through study completion, up to 2 years
Implementation of Community-Focused Patient Navigation (CFPN) program
Time Frame: Through study completion, up to 2 years
Data will be collected via a study-specific patient survey to examine acceptability, appropriateness, and feasibility of the CFPN program. Data will be analyzed using SAS to calculate means, standard deviations, and ranges.
Through study completion, up to 2 years
Attrition
Time Frame: Through study completion, up to 2 years
Number of patients lost to follow up will be examined to establish the reach of the Community-Focused Patient Navigation (CFPN) program.
Through study completion, up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)
Pfizer
American Cancer Society, Inc.

Investigators

  • Principal Investigator: Claradina Soto, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2026

Primary Completion (Estimated)

November 13, 2027

Study Completion (Estimated)

November 13, 2028

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 7, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19PS-25-8 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2025-08365 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • UP-25-00814

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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