Coverage and Cost-of-Care (CC) Links- Financial Navigation Program

Study Overview
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Brief Summary
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This trial is a mixed-methods, non-randomized design guided by the Consolidated Framework for Implementation Research (CFIR) to develop, implement, and evaluate Coverage and Cost-of-Care Links (CC Links) -a novel financial navigation intervention for hematologic cancer survivors and their caregivers.

Detailed Description
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The CC Links intervention included an oncology financial navigator who worked in the Hematology-Oncology Clinic. The navigator's functions included: screening for financial hardship to identify unmet financial needs (using the Comprehensive Score for Financial Toxicity (COST) and National Comprehensive Cancer Network's Distress Thermometer; initiating cost of care conversations; providing cost of care estimates; ensuring adequate health insurance coverage and assisting with applying for additional coverage; assisting with internal financial assistance program applications; connecting survivors/caregivers with disease specific resources and other external assistance programs; coordinating discharge planning; referring survivors to social workers and other staff/resources as needed; and, coordinating financial assistance services as survivors/caregivers transition between outpatient and inpatient settings.

Official Title
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Coverage and Cost-of-Care Links Financial Navigation Program in Hematology and Blood and Bone Marrow Transplantation (BMT)

Conditions
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Financial Stress, Hematologic Cancer, Survivorship

Intervention / Treatment
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* Other: CC Links


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hematological cancer patients from the Division of Hematology and Bone Marrow Transplantation at the University of Kentucky caregivers of cancer patients positive screening for financial hardship Exclusion Criteria: - unable to provide consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Financial Navigation- Patients Only<br>Patients only participated in financial navigation program. | Other: CC Links<br>* The CC Links intervention is built on a platform of interdisciplinary team-based science, which ensured that the financial navigator worked closely with other members of the healthcare team including oncologists, nurses, transplant coordinators, social workers, and case managers, to help enhance financial hardship screening and connect survivors and caregivers with financial assistance services.<br>|
| Experimental: Financial Navigation- Patient and Caregiver<br>Patients and their caregivers participated as a dyad in financial navigation program. | Other: CC Links<br>* The CC Links intervention is built on a platform of interdisciplinary team-based science, which ensured that the financial navigator worked closely with other members of the healthcare team including oncologists, nurses, transplant coordinators, social workers, and case managers, to help enhance financial hardship screening and connect survivors and caregivers with financial assistance services.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coping behaviors | Coping behaviors was measured using a series of 9 yes/no items that first assess whether any recommended cancer care was skipped for any reason (yes/no), and then whether the reason for not receiving the care that they or their doctor believed necessary was due to any of 8 listed reasons (yes/no for each). Typical reasons included 'Couldn't afford care,' 'Insurance company wouldn't approve or pay for care,' and 'Had problems getting to the doctor's office.' The sum of the number of yes responses is the total score, with higher scores indicating greater coping behaviors in response to financial hardship. The items in this scale are from the Medical Expenditure Panel Survey - Experiences with Cancer Survivorship Survey (MEPS-ECSS). | Approximately 8 months (baseline and following resolution of financial needs) | 
| Change in material conditions | Material conditions was measured using 8 items (6 from the Medical Expenditure Panel Survey: Experiences with Cancer Survivorship Supplement (MEPS-ECSS) and 2 from demographic survey) that measure the financial condition of the participant with cancer and their family. Six of the items are yes/no and these include questions on borrowing money or go into debt, filing for bankruptcy, and concerns about having to pay large medical bills because of the cost of cancer treatment. The remaining two items are ordinal and measure the amount of debt related to cancer costs (options range from $0 to $100,00+), and the how they perceive their household's income currently (choices range from 'living comfortably on present income' to 'finding it very difficult on present income'). The latter two items are rescaled to 0-1 variables, so they have the same ranges as the yes/no items and are summed to create the total score. Higher scores indicate greater financial hardship. | Approximately 8 months (baseline and following resolution of financial needs) | 
| Change in psychological response (financial toxicity) | Psychological response (i.e. financial toxicity) was measured using the 11-item Comprehensive Score for Financial Toxicity (COST) that measures emotional aspects of financial hardship (financial toxicity) among cancer patients. Each item is scored on a 5-point ordinal scale ranging from 0='Not at all' to 4='Very much.' Sample items include 'My out-of-pocket expense are more than I thought they would be' and 'I am frustrated that I cannot work or contribute as much as I usually do.' Lower values indicate greater financial toxicity. | Approximately 8 months (baseline and following resolution of financial needs) | 
| Change in health-related quality of life | Health-related QOL was measured using four Patient-Reported Outcomes Measurement Information System (PROMIS) scales.xx Each of these were scored and standardized by submitting the raw values to the HealthMeasures scoring service. We used the standardized values of the total scores throughout the analysis for this study. The four scales include the PROMIS physical health and emotional health subscales (from the 10-item PROMIS Scale v1.2 - Global Health),xx the 4-item PROMIS- Anxiety Short Form, and the 6-item PROMIS-Depression Short Form. The physical (physical health, function, pain, and fatigue items) and emotional health (QOL, mental health, social activities, and emotional problem items) subscales are each based on 4 items, with higher scores indicating a more positive health self-assessment. For the anxiety and depression scales, higher scores indicate a greater manifestation of symptoms. | Approximately 8 months (baseline and following resolution of financial needs) | 
| Change in distress. | Distress was measured using the National Comprehensive Cancer Network's (NCCN) Distress Thermometer and its accompanying 40-item problem list. A cutoff score of 4 indicated clinically elevated distress levels | Approximately 8 months (baseline and following resolution of financial needs) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Financial Savings | Amount of money saved per patient including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges. | Approximately at 8 months (following resolution of financial needs) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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financial navigation, quality of life, hardship, caregivers, financial toxicity