An interventional study of Discussion and Discussion in Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, sponsored by University of Southern California. Recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by University of Southern California · Not applicable, Interventional, and Supportive care
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.
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.
University of Southern California is the lead sponsor of 773 studies on the registry; 135 are open to participants now.
Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants serve on a CAB to guide the co-design process of the CFPN program on study.
Other: Discussion
Participants complete a focus group over 1-2 hours in support of the co-design process of the CFPN program on study.
Other: Discussion
Participants complete a KII over 30 minutes in support of the co-design process of the CFPN program on study.
Other: Interview
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 · Other: Electronic Health Record Review · Other: Interview · Behavioral: Patient Navigation · Other: Survey Administration · Procedure: Tailored Intervention
Serve on CAB
Also known as: Discuss
Complete focus group
Also known as: Discuss
Receive opioid misuse education and care coordination
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Ancillary studies
Complete KII
Ancillary studies
Engage with CFPN program navigator
Also known as: Patient Navigator Program
Ancillary studies
Receive treatment plan
Focus group themes and emerging codes
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.
Time frame: Through study completion, up to 2 years
Key informant interview findings and proposed strategies
Will prepare a report with the findings and proposed strategies and discuss it with TIHP Co-PI and CAB.
Time frame: Through study completion, up to 2 years
Qualitative Effectiveness of Community-Focused Patient Navigation (CFPN) program
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.
Time frame: Through study completion, up to 2 years
Quantitative Effectiveness of Community-Focused Patient Navigation (CFPN) program
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.
Time frame: Through study completion, up to 2 years
Implementation of Community-Focused Patient Navigation (CFPN) program
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.
Time frame: Through study completion, up to 2 years
Attrition
Number of patients lost to follow up will be examined to establish the reach of the Community-Focused Patient Navigation (CFPN) program.
Time frame: Through study completion, up to 2 years
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Southern California