Hematopoietic and Lymphatic System NeoplasmNCT07332312
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
A study testing Discussion, Educational Intervention and Electronic Health Record Review in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Southern California at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Discussion, Educational Intervention and Electronic Health Record Review
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2026to 13 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Toiyabe Indian Health Project
Bishop, California, 93514
Tina Cassar, 760-872-2622, tina.cassar@toiyabe.us
Tina Cassar
- Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Claradina Soto, 323-442-8219, toya@usc.edu
Claradina Soto
About this study
Official title: Developing a Culturally Informed Patient Navigation Program to Reduce Delays From Diagnosis to Treatment for Native Americans in a Rural Setting
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Discussion, Educational Intervention, Electronic Health Record Review, Interview, Patient Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiscussionOther
Also called Discuss
Serve on CAB
DiscussionOther
Also called Discuss
Complete focus group
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive opioid misuse education and care coordination
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Complete KII
InterviewOther
Ancillary studies
Patient NavigationBehavioural
Also called Patient Navigator Program
Engage with CFPN program navigator
Survey AdministrationOther
Ancillary studies
Tailored InterventionProcedure or surgery
Receive treatment plan
| Study group | Role | What they receive |
|---|---|---|
| Objective 1 group I (CAB) | Other | Participants serve on a CAB to guide the co-design process of the CFPN program on study. Receives: Other: Discussion |
| 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. Receives: Other: Discussion |
| 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. Receives: Other: Interview |
| 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. Receives: Other: Educational Intervention; Other: Electronic Health Record Review; Other: Interview; Behavioral: Patient Navigation; Other: Survey Administration; Procedure: Tailored Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start17 Apr 2026
- Primary completion13 Nov 2027 (estimated)
- Study completion13 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc., Pfizer
- Responsible party
- Sponsor
- Investigators
- Claradina Soto, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332312
- Sponsor's protocol ID
- 19PS-25-8
- Other IDs
- NCI-2025-08365, UP-25-00814, 19PS-25-8, P30CA014089
- Status last verified
- May 2026
- First submitted
- 3 Dec 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Culturally Informed Patient Navigation Program to Reduce Delays From Diagnosis to Treatment for Native Americans in a Rural Setting
- ClinicalTrials.gov ID
- NCT07332312
- Acronym / sponsor ID
- 19PS-25-8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc., Pfizer
- Study start
- 17 Apr 2026 (actual)
- Primary completion
- 13 Nov 2027 (estimated)
- Study completion
- 13 Nov 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Objective 1 group I (CAB) | Other | Other: DiscussionParticipants serve on a CAB to guide the co-design process of the CFPN program on study. |
| Objective 1 group II (focus group) | Other | Other: DiscussionParticipants complete a focus group over 1-2 hours in support of the co-design process of the CFPN program on study. |
| Objective 1 group III (KII) | Other | Other: InterviewParticipants complete a KII over 30 minutes in support of the co-design process of the CFPN program on study. |
| Objective 2 (CFPN program) | Experimental | Other: Educational Intervention, Other: Electronic Health Record Review, Other: Interview, Behavioral: Patient Navigation, Other: Survey Administration, Procedure: Tailored InterventionPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DiscussionAlso: DiscussServe on CAB | Other | Objective 1 group I (CAB) |
| DiscussionAlso: DiscussComplete focus group | Other | Objective 1 group II (focus group) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive opioid misuse education and care coordination | Other | Objective 2 (CFPN program) |
| Electronic Health Record ReviewAncillary studies | Other | Objective 2 (CFPN program) |
| InterviewComplete KII | Other | Objective 1 group III (KII) |
| InterviewAncillary studies | Other | Objective 2 (CFPN program) |
| Patient NavigationAlso: Patient Navigator ProgramEngage with CFPN program navigator | Behavioural | Objective 2 (CFPN program) |
| Survey AdministrationAncillary studies | Other | Objective 2 (CFPN program) |
| Tailored InterventionReceive treatment plan | Procedure or surgery | Objective 2 (CFPN program) |
Primary outcome
Focus group themes and emerging codes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claradina Soto principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Discussion, Educational Intervention and Electronic Health Record Review in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by University of Southern California at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Focus group themes and emerging codes (time frame: Through study completion, up to 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.