NCT07332312 · University of Southern California
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
What this study is about
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.
View original scientific description
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.
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
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.
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.
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Bishop, California
- Los Angeles, California
Collaborators
National Cancer Institute (NCI), American Cancer Society, Inc., Pfizer
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2026 · Source of record for eligibility and locations