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

The University of Alabama at Birmingham

Status: Enrolling

Conditions: Oncology; Financial Toxicity; Counseling

Treatments: Behavioral: Financial navigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07281287

IRB-300012763

1K01CA296932 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Patients receiving standard-of-care-delivered financial navigation

Experimental group

Treatment:

Behavioral: Financial navigation

Historical control patients who did not receive financial navigation

No Intervention group