Developing a Culturally Informed Patient Navigation Program to Reduce Delays From Diagnosis to Treatment for Native Americans in a Rural Setting
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.
Detailed description
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.
Arms & interventions
- OtherDiscussion
Serve on CAB
- OtherDiscussion
Complete focus group
- OtherEducational Intervention
Receive opioid misuse education and care coordination
- OtherElectronic Health Record Review
Ancillary studies
- OtherInterview
Complete KII
- OtherInterview
Ancillary studies
- BehavioralPatient Navigation
Engage with CFPN program navigator
- OtherSurvey Administration
Ancillary studies
- ProcedureTailored Intervention
Receive treatment plan
Outcome measures
Primary
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 criteria
Study locations (2)
Toiyabe Indian Health Project
Bishop, California, 93514
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033