The overall objective of this study is to develop and implement CC LinksTele (Coverage and Cost-of-Care Links- Telehealth)- a multilevel intervention designed to empower pediatric cancer patients, caregivers, and healthcare teams with the resources to reduce financial toxicity by addressing patient and caregiver financial health literacy (individual-level) and cancer care delivery pathways and workflows to address financial hardship (health system-level).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
124
Study participants will be contacted by a TRIAGE Cancer staff member via phone and will receive one-on-one education, coaching and/or navigation of cancer-related financial and/or legal issues. These navigation sessions can take an average of 1 to 3 hours depending on the participants needs.
University of Kentucky
Lexington, Kentucky, United States
Program Acceptability
Acceptability will be measured as mean post-intervention ratings of greater than 7-10 on financial navigation program relevance, helpfulness, convenience, recommendation to others and value (0=not at all to 10=extremely).
Time frame: 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.
Time frame: 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. standardized values of the total scores were used 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.
Time frame: 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
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Time frame: Approximately 8 months (baseline and following resolution of financial needs)
Change in health insurance literacy
single item, yes/no question "Did you ever have a problem understanding health insurance or medical bills related to your cancer, its treatment, or the lasting effects of that treatment?"
Time frame: Approximately 8 months (baseline and following resolution of financial needs)
Program Feasibility
Feasibility will be measured using the entire sample of program participants and will be defined by number enrolled
Time frame: 8 months
Program Adherence
Adherence will be measured using the entire sample of program participants and will be defined by percentage of participants that maintain communication and provide required information to resolve financial issues
Time frame: 8 months
Financial Savings
Amount of money saved per patient including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges.
Time frame: Approximately at 8 months (following resolution of financial needs)