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

Purpose

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

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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
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
    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
    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: Educational Intervention
    Receive opioid misuse education and care coordination
    Other names:
    • Education for Intervention
    • Intervention by Education
    • Intervention through Education
    • Intervention, Educational
  • Other: Electronic Health Record Review
    Ancillary studies
  • Other: Interview
    Ancillary studies
  • Behavioral: Patient Navigation
    Engage with CFPN program navigator
    Other names:
    • Patient Navigator Program
  • Other: Survey Administration
    Ancillary studies
  • Procedure: Tailored Intervention
    Receive treatment plan

Recruiting Locations

Toiyabe Indian Health Project
Bishop, California 93514
Contact:
Tina Cassar
760-872-2622
tina.cassar@toiyabe.us

USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Contact:
Claradina Soto
323-442-8219
toya@usc.edu

More Details

Status
Recruiting
Sponsor
University of Southern California

Study Contact

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.