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NCT Number: NCT07281287

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

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.

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Key information

Conditions

Oncology Behavior Behavioral Symptoms Counseling Financial Stress Financial Toxicity Neoplasms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Aim 1:

Inclusion criteria

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

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

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

Exclusion criteria

None.

Aim 3:

Inclusion criteria

  • 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

Exclusion criteria

None.

Treatment and study plan

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.

Primary outcomes

  1. Change in financial hardship

    Time frame: 6 months post-initiation of systemic therapy

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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Courtney Williams, DrPH

CONTACT

[email protected]

205-975-0462

Hayden Reeves, BS

CONTACT

[email protected]

205-996-4109

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2025
Primary completion
2029
Study completion
2030
First posted
Dec 15, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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