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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Focus group themes and emerging codes [Time frame: Through study completion, up to 2 years]
• Key informant interview findings and proposed strategies [Time frame: 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]
• Quantitative Effectiveness of Community-Focused Patient Navigation (CFPN) program [Time frame: Through study completion, up to 2 years]
• Implementation of Community-Focused Patient Navigation (CFPN) program [Time frame: Through study completion, up to 2 years]
• Attrition [Time frame: Through study completion, up to 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Toiyabe Indian Health Project — Bishop
• USC / Norris Comprehensive Cancer Center — Los Angeles

Identifiers

NCT: NCT07332312 · 19PS-25-8 · NCI-2025-08365 · UP-25-00814 · 19PS-25-8 · P30CA014089

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗