Counseling, Financial Toxicity, Oncology
Conditions
Keywords
Financial Navigation, Out of pocket cost, Oncology, oncology Financial hardship
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. 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
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.
Sponsors
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in financial hardship | 6 months post-initiation of systemic therapy | Change in patient-reported financial distress (COmprehensive Score for financial Toxicity) |
| Change in financial difficulties | 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) |
| Change in quality of life | 6 months post-initiation of systemic therapy | Change in patient-reported quality of life (PROMIS v1.1 Global Health) |
| Change in psychological distress | 6 months post-initiation of systemic therapy | Change in patient-reported psychological distress (National Comprehensive Cancer Network Distress Thermometer) |
| Utilization of implementation strategies | 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) |
| 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 | Using qualitative interviews, we will assess patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies |
Countries
United States
Contacts
CONTACTHayden Reeves, BS
CONTACTCourtney Williams, DrPH
PRINCIPAL_INVESTIGATORCourtney Williams, DrPH
University of Alabama at Birmingham
Outcome results
None listed