Recruiting

CFPN

Sponsor:

University of Southern California

Code:

NCT07332312

Conditions

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Discussion

Discussion

Educational Intervention

Electronic Health Record Review

Interview

Study Details

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

Hematopoietic and Lymphatic System Neoplasm

Malignant Solid Neoplasm

Study ID

NCT07332312

Start date

Apr 17, 2026

Status verified date

May, 2026

Completion date

Nov 13, 2028

Anticipated

Primary completion date

Nov 13, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

71 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Objective 1 group I (CAB)

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

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: 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.

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.

Interventions

Discussion

Serve on CAB

Discussion

Complete focus group

Educational Intervention

Receive opioid misuse education and care coordination

Electronic Health Record Review

Ancillary studies

Interview

Complete KII

Interview

Ancillary studies

Patient Navigation

Engage with CFPN program navigator

Survey Administration

Ancillary studies

Tailored Intervention

Receive treatment plan

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Toiyabe Indian Health Project

Recruiting

Bishop, California, United States, 93514

Contacts

Tina Cassar

760-872-2622tina.cassar@toiyabe.us

Principal Investigator:

Tina Cassar

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Claradina Soto

323-442-8219toya@usc.edu

Principal Investigator:

Claradina Soto

More Information

Sponsor

University of Southern California

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-05-11.