Clinical trial NCT05465577: Coverage and Cost-of-Care (CC) Links- Financial Navigation Program
Official title: Coverage and Cost-of-Care Links Financial Navigation Program in Hematology and Blood and Bone Marrow Transplantation (BMT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Financial Stress
Hematologic Cancer
Survivorship
Keywords: financial navigation
quality of life
hardship
caregivers
financial toxicity
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in coping behaviors
timeFrame: Approximately 8 months (baseline and following resolution of financial needs)
measure: Change in material conditions
timeFrame: Approximately 8 months (baseline and following resolution of financial needs)
measure: Change in psychological response (financial toxicity)
timeFrame: Approximately 8 months (baseline and following resolution of financial needs)
measure: Change in health-related quality of life
timeFrame: Approximately 8 months (baseline and following resolution of financial needs)
measure: Change in distress.
timeFrame: Approximately 8 months (baseline and following resolution of financial needs)
Secondary outcomes:
measure: Financial Savings
timeFrame: Approximately at 8 months (following resolution of financial needs)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Jean S Edward, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: