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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-08365 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UP-25-00814 | |||
| 19PS-25-8 | Other Identifier | USC / Norris Comprehensive Cancer Center | |
| P30CA014089 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| American Cancer Society, Inc. | OTHER |
| Pfizer | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Objective 1 group I (CAB) | Other | Participants serve on a CAB to guide the co-design process of the CFPN program on study. |
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| Objective 1 group II (focus group) | Other | Participants complete a focus group over 1-2 hours in support of the co-design process of the CFPN program on study. |
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| Objective 1 group III (KII) | Other | Participants complete a KII over 30 minutes in support of the co-design process of the CFPN program on study. |
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| Objective 2 (CFPN program) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discussion | Other | Serve on CAB |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claradina Soto | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toiyabe Indian Health Project | Recruiting | Bishop | California | 93514 | United States |
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| Discussion | Other | Complete focus group |
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| Educational Intervention | Other | Receive opioid misuse education and care coordination |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Interview | Other | Complete KII |
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| Interview | Other | Ancillary studies |
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| Patient Navigation | Behavioral | Engage with CFPN program navigator |
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| Survey Administration | Other | Ancillary studies |
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| Tailored Intervention | Procedure | Receive treatment plan |
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| 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. | Through study completion, up to 2 years |
| USC / Norris Comprehensive Cancer Center | Recruiting | Los Angeles | California | 90033 | United States |
|
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D007407 | Interviews as Topic |
| D062526 | Patient Navigation |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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