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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01CA296932 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
Researchers will examine secondary, standard-of-care collected, patient-reported data, electronic medical record data, and qualitative interview data to answer these questions.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving standard-of-care-delivered financial navigation | Experimental |
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| Historical control patients who did not receive financial navigation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in financial hardship | Change in patient-reported financial distress (COmprehensive Score for financial Toxicity) | 6 months post-initiation of systemic therapy |
| 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) | 6 months post-initiation of systemic therapy |
| Change in quality of life | Change in patient-reported quality of life (PROMIS v1.1 Global Health) | 6 months post-initiation of systemic therapy |
| Change in psychological distress | Change in patient-reported psychological distress (National Comprehensive Cancer Network Distress Thermometer) | 6 months post-initiation of systemic therapy |
| Utilization of implementation strategies | 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) | 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 | Using qualitative interviews, we will assess patient, provider, and health system perspectives of oncology financial navigation implementation barriers addressed via implementation strategies |
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Aim 1:
Inclusion criteria: As oncology financial navigation will be implemented as standard of care, implementation outcomes will be evaluated for:
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:
Exclusion criteria: None.
Aim 3:
Inclusion criteria:
Exclusion criteria: None.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hayden Reeves, BS | Contact | 205-996-4109 | haydenreeves@uabmc.edu | |
| Courtney Williams, DrPH | Contact | 205-975-0462 | courtneywilliams@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Courtney Williams, DrPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Feb 28, 2025 | Dec 11, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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| Annually through study completion, an average of 4 years |