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RecruitingInterventional

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

NCT ID: NCT07281287Sponsor: University of Alabama at BirminghamLast updated: 2026-02-24

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. 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.

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

Arms & interventions

  • BehavioralFinancial 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.

Outcome measures

Primary

  • Change in financial hardship

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

    Time frame: 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)

    Time frame: 6 months post-initiation of systemic therapy

  • Change in quality of life

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

    Time frame: 6 months post-initiation of systemic therapy

  • Change in psychological distress

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

    Time frame: 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)

    Time frame: 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

    Time frame: Annually through study completion, an average of 4 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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 locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

Recruiting
Hayden Reeves, BS · Contact
Courtney Williams, DrPH · Contact