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

NCT07332312 | Recruiting DMC

• 4 other identifiers: 19PS-25-8NCI-2025-08365UP-25-00814P30CA014089
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Malignant Solid Neoplasm; Hematopoietic and Lymphatic System Neoplasm

Outcome Measures

Primary Outcomes (6)

• Focus group themes and emerging codes

  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

  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

  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

  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

  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

  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

Study Arms (4)

Objective 1 group I (CAB)

OTHER

Participants serve on a CAB to guide the co-design process of the CFPN program on study.

Other: Discussion

Objective 1 group II (focus group)

OTHER

Participants complete a focus group over 1-2 hours in support of the co-design process of the CFPN program on study.

Other: Discussion

Objective 1 group III (KII)

OTHER

Participants complete a KII over 30 minutes in support of the co-design process of the CFPN program on study.

Other: Interview

Objective 2 (CFPN program)

EXPERIMENTAL

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: Educational Intervention; Other: Electronic Health Record Review; Other: Interview; Behavioral: Patient Navigation; Other: Survey Administration; Procedure: Tailored Intervention

Interventions

Discussion OTHER

Serve on CAB

Also known as: Discuss

Objective 1 group I (CAB)

Educational Intervention OTHER

Receive opioid misuse education and care coordination

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Objective 2 (CFPN program)

Interview OTHER

Complete KII

Objective 1 group III (KII)

Patient Navigation BEHAVIORAL

Engage with CFPN program navigator

Also known as: Patient Navigator Program

Objective 2 (CFPN program)

Survey Administration OTHER

Ancillary studies

Objective 2 (CFPN program)

Tailored Intervention PROCEDURE

Receive treatment plan

Objective 2 (CFPN program)

Electronic Health Record Review OTHER

Ancillary studies

Objective 2 (CFPN program)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• Pfizer: collaborator
• University of Southern California: lead
• American Cancer Society, Inc.: collaborator

Study Sites (2)

Toiyabe Indian Health Project

Bishop, California, 93514, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods; Interviews as Topic; Patient Navigation

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Claradina Soto

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: January 12, 2026
• Study Start: April 17, 2026
• Primary Completion (Estimated): November 13, 2027
• Study Completion (Estimated): November 13, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (2)