Evaluating the Implementation and Impact of Standard-of-care Delivered Oncology Financial Navigation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Financial navigation.
- Who it may be relevant to
- Registry conditions: Oncology, Financial Toxicity, Counseling. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Financial 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.
Primary outcome measures
- Change in financial hardship [Time frame: 6 months post-initiation of systemic therapy]
- Change in financial difficulties [Time frame: 6 months post-initiation of systemic therapy]
- Change in quality of life [Time frame: 6 months post-initiation of systemic therapy]
- Change in psychological distress [Time frame: 6 months post-initiation of systemic therapy]
- Utilization of implementation strategies [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 [Time frame: Annually through study completion, an average of 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Identifiers
NCT: NCT07281287 · IRB-300012763 · 1K01CA296932