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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

UAB oncology financial navigators

Disqualifiers

Patients with cancer seen at the UAB Medical Oncology clinic

Patients with non-missing patient-reported outcome data

Patients who have received oncology financial navigation

Providers (oncology financial navigators, social workers, nurse managers, oncologists) involved with the oncology financial navigation program

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Patients receiving standard-of-care-delivered financial navigationExperimental treatment 1 intervention
Group B: Historical control patients who did not receive financial navigationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in financial hardship

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

Time frame
6 months post-initiation of systemic therapy
2

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
3

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
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Alabama at Birmingham

Lead sponsor

National Cancer Institute (NCI)

Collaborator