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
NCT ID: NCT07332312
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
71 participants
INTERVENTIONAL
2026-01-30
2028-11-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cancer Prevention and Treatment Demonstration for Ethnic and Racial Minorities
NCT00453661
Enhancing Cancer Prevention and Control Pathways-Native Health Initiative
NCT04259762
CoGENES Randomized Controlled Trial (RCT)
NCT07229443
Support Program for Adoption of Cancer Screening Interventions at a Rural Community-Based Organization
NCT04208724
Enhancing Prevention Pathways Toward Tribal Colorectal Health
NCT02882620
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Objective 1 group I (CAB)
Participants serve on a CAB to guide the co-design process of the CFPN program on study.
Discussion
Serve on CAB
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.
Discussion
Complete focus group
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.
Interview
Complete KII
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.
Electronic Health Record Review
Ancillary studies
Interview
Ancillary studies
Patient Navigation
Engage with CFPN program navigator
Survey Administration
Ancillary studies
Tailored Intervention
Receive treatment plan
Educational Intervention
Receive opioid misuse education and care coordination
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Discussion
Serve on CAB
Discussion
Complete focus group
Educational Intervention
Receive opioid misuse education and care coordination
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* CFPN PROGRAM IMPLEMENTATION: Not a TIHP patient
* CFPN PROGRAM IMPLEMENTATION: Does not currently have cancer or has not previously had cancer
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
American Cancer Society, Inc.
OTHER
Pfizer
INDUSTRY
University of Southern California
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claradina Soto
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Toiyabe Indian Health Project
Bishop, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Tina Cassar
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2025-08365
Identifier Type: REGISTRY
Identifier Source: secondary_id
UP-25-00814
Identifier Type: -
Identifier Source: secondary_id
19PS-25-8
Identifier Type: OTHER
Identifier Source: secondary_id
19PS-25-8
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.