Skip to main content
OpenTrials
Completed

NCT Number: NCT05465577

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CC Links

Other

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.

Primary outcomes

  1. Change in coping behaviors

    Time frame: Approximately 8 months (baseline and following resolution of financial needs)

    "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).

  2. Change in material conditions

    Time frame: Approximately 8 months (baseline and following resolution of financial needs)

    "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.

  3. Change in psychological response (financial toxicity)

    Time frame: Approximately 8 months (baseline and following resolution of financial needs)

    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.

  4. Change in health-related quality of life

    Time frame: Approximately 8 months (baseline and following resolution of financial needs)

    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.

  5. Change in distress.

    Time frame: Approximately 8 months (baseline and following resolution of financial needs)

    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

Secondary outcomes

  1. Financial Savings

    Time frame: Approximately at 8 months (following resolution of financial needs)

    Amount of money saved per patient including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges.

Sponsors and collaborators

Lead sponsor

Jean Edward

Other

Registry information

Official study title

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

Acronym: CC Links

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2022
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.