Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Conditions
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.
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.
Interventions
OTHERDiscussion
Serve on CAB
OTHEREducational Intervention
Receive opioid misuse education and care coordination
OTHERElectronic Health Record Review
Ancillary studies
OTHERInterview
Complete KII
BEHAVIORALPatient Navigation
Engage with CFPN program navigator
OTHERSurvey Administration
Ancillary studies
PROCEDURETailored Intervention
Receive treatment plan
Sponsors
University of Southern California
National Cancer Institute (NCI)
American Cancer Society, Inc.
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Focus group themes and emerging codes | Through study completion, up to 2 years | 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. |
| Key informant interview findings and proposed strategies | Through study completion, up to 2 years | Will prepare a report with the findings and proposed strategies and discuss it with TIHP Co-PI and CAB. |
| Qualitative Effectiveness of Community-Focused Patient Navigation (CFPN) program | Through study completion, up to 2 years | 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. |
| Quantitative Effectiveness of Community-Focused Patient Navigation (CFPN) program | Through study completion, up to 2 years | 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. |
| Implementation of Community-Focused Patient Navigation (CFPN) program | Through study completion, up to 2 years | 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. |
| Attrition | Through study completion, up to 2 years | Number of patients lost to follow up will be examined to establish the reach of the Community-Focused Patient Navigation (CFPN) program. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORClaradina Soto
University of Southern California
Outcome results
None listed