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

NCT07281287 | Recruiting

• 2 other identifiers: IRB-3000127631K01CA296932
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oncology; Financial Toxicity; Counseling

Keywords

Financial Navigation; Out of pocket cost; Oncology; oncology Financial hardship

Outcome Measures

Primary Outcomes (6)

• Change in financial hardship

  Change in patient-reported financial distress (COmprehensive Score for financial Toxicity)

  6 months post-initiation of systemic therapy

• Change in financial difficulties

  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

  Change in patient-reported quality of life (PROMIS v1.1 Global Health)

  6 months post-initiation of systemic therapy

• Change in psychological distress

  Change in patient-reported psychological distress (National Comprehensive Cancer Network Distress Thermometer)

  6 months post-initiation of systemic therapy

• Utilization of implementation strategies

  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

  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

Study Arms (2)

Patients receiving standard-of-care-delivered financial navigation

EXPERIMENTAL

Behavioral: Financial navigation

Historical control patients who did not receive financial navigation

NO INTERVENTION

Interventions

Financial navigation BEHAVIORAL

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.

Patients receiving standard-of-care-delivered financial navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Aim 2:
• Patients with cancer seen at the UAB Medical Oncology clinic
• Patients with non-missing patient-reported outcome data
• Aim 3:
• Patients who have received oncology financial navigation
• Providers (oncology financial navigators, social workers, nurse managers, oncologists) involved with the oncology financial navigation program
• Health system team members (billing specialists, cancer service line leadership) involved with the oncology financial navigation program

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Courtney Williams, DrPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayden Reeves, BS

CONTACT

205-996-4109; haydenreeves@uabmc.edu

Courtney Williams, DrPH

CONTACT

205-975-0462; courtneywilliams@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This will be a secondary data analysis of patient-reported data routinely collected since 2020 for patients with cancer seen at the UAB Medical Oncology clinic. All patients with data will be included in the analysis, as this is an evaluation of oncology financial navigation integration into real-world clinical teams. Therefore, due to a lack of comparable controls during the oncology financial navigation intervention, we will use historical controls matched by sociodemographic and cancer characteristics for comparison.

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 15, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)