Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation

February 20, 2026 updated by: Courtney Williams, University of Alabama at Birmingham

The purpose of this study is to understand the implementation and impact of a pragmatically-delivered oncology financial navigation program. The main questions it aims to answer are:

  1. How did oncology financial navigation implementation strategies affect implementation outcomes?
  2. What is the impact of financial navigation on patient financial hardship, quality of life, and psychological distress?
  3. How were implementation strategies utilized to overcome barriers to oncology financial navigation?

Researchers will examine secondary, standard-of-care collected, patient-reported data, electronic medical record data, and qualitative interview data to answer these questions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Guided by the RE-AIM Extension for Equitable Sustainability framework, the investigators will use a series of implementation and effectiveness aims to evaluate equitable implementation of oncology financial navigation into routine cancer care delivery. The investigators hypothesize the proposed assessment will identify potential areas to improve implementation of oncology financial navigation, which will result in better financial and clinical outcomes for patients with cancer. The investigators propose a pragmatic, hybrid effectiveness-implementation study to assess outcomes of oncology financial navigation delivered as routine cancer care and collect information on strategies to address implementation barriers. Outcomes will be assessed overall and for inequities by race, residence, and insurance status using the following specific aims:

Aim 1. Track oncology financial navigation implementation strategies and their effect on implementation outcomes

Aim 2. Evaluate oncology financial navigation effectiveness

Aim 3. Assess how implementation strategies were utilized to overcome barriers to oncology financial navigation

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Aim 1:

Inclusion criteria: As oncology financial navigation will be implemented as standard of care, implementation outcomes will be evaluated for:

  1. All patients with cancer seen at the University of Alabama at Birmingham (UAB) Medical Oncology clinic
  2. UAB oncology financial navigators

Exclusion criteria: None.

Aim 2:

Inclusion criteria: This will be a secondary data analysis of patient-reported data routinely collected since 2020, which will include:

  1. Patients with cancer seen at the UAB Medical Oncology clinic
  2. Patients with non-missing patient-reported outcome data

Exclusion criteria: None.

Aim 3:

Inclusion criteria:

  1. Patients who have received oncology financial navigation
  2. Providers (oncology financial navigators, social workers, nurse managers, oncologists) involved with the oncology financial navigation program
  3. Health system team members (billing specialists, cancer service line leadership) involved with the oncology financial navigation program

Exclusion criteria: None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients receiving standard-of-care-delivered financial navigation
Behavioral: Financial navigation
Oncology financial navigation is an evidence-based intervention which helps patients prepare for out-of-pocket treatment costs, optimize health insurance, and access financial resources to reduce cancer-related financial hardship.
No Intervention: Historical control patients who did not receive financial navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in financial hardship
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported financial distress (COmprehensive Score for financial Toxicity)
6 months post-initiation of systemic therapy
Change in financial difficulties
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported financial difficulties (trouble paying for basic needs, utilities, transportation or lodging for treatment, medications, medical supplies, upfront medical payments, insurance or medical bills, child or eldercare, and employment or disability issues)
6 months post-initiation of systemic therapy
Change in quality of life
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported quality of life (PROMIS v1.1 Global Health)
6 months post-initiation of systemic therapy
Change in psychological distress
Time Frame: 6 months post-initiation of systemic therapy
Change in patient-reported psychological distress (National Comprehensive Cancer Network Distress Thermometer)
6 months post-initiation of systemic therapy
Utilization of implementation strategies
Time Frame: Quarterly tracking of strategies with monthly assessment of implementation outcomes, through study completion, an average of 4 years
Track oncology financial navigation implementation strategies using the Expert Recommendations for Implementing Change (ERIC) implementation strategy taxonomy and their effect on implementation outcomes of Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM)
Quarterly tracking of strategies with monthly assessment of implementation outcomes, through study completion, an average of 4 years
Patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Time Frame: Annually through study completion, an average of 4 years
Using qualitative interviews, we will assess patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies
Annually through study completion, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Courtney Williams, DrPH, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

December 11, 2025

First Posted (Actual)

December 15, 2025

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-300012763
  • 1K01CA296932 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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