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

Primary Purpose

Financial Stress, Hematologic Cancer, Survivorship

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CC Links
Sponsored by
Jean Edward
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Financial Stress focused on measuring financial navigation, quality of life, hardship, caregivers, financial toxicity

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Financial Navigation- Patients Only

Financial Navigation- Patient and Caregiver

Arm Description

Patients only participated in financial navigation program.

Patients and their caregivers participated as a dyad in financial navigation program.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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

Secondary Outcome Measures

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

Full Information

First Posted
July 15, 2022
Last Updated
July 15, 2022
Sponsor
Jean Edward
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1. Study Identification

Unique Protocol Identification Number
NCT05465577
Brief Title
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program
Acronym
CC Links
Official Title
Coverage and Cost-of-Care Links Financial Navigation Program in Hematology and Blood and Bone Marrow Transplantation (BMT)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
February 1, 2022 (Actual)
Study Completion Date
February 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jean Edward

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Financial Stress, Hematologic Cancer, Survivorship
Keywords
financial navigation, quality of life, hardship, caregivers, financial toxicity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Financial Navigation- Patients Only
Arm Type
Experimental
Arm Description
Patients only participated in financial navigation program.
Arm Title
Financial Navigation- Patient and Caregiver
Arm Type
Experimental
Arm Description
Patients and their caregivers participated as a dyad in financial navigation program.
Intervention Type
Other
Intervention Name(s)
CC Links
Intervention Description
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 Outcome Measure Information:
Title
Change in coping behaviors
Description
"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).
Time Frame
Approximately 8 months (baseline and following resolution of financial needs)
Title
Change in material conditions
Description
"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.
Time Frame
Approximately 8 months (baseline and following resolution of financial needs)
Title
Change in psychological response (financial toxicity)
Description
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)
Title
Change in health-related quality of life
Description
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.
Time Frame
Approximately 8 months (baseline and following resolution of financial needs)
Title
Change in distress.
Description
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
Time Frame
Approximately 8 months (baseline and following resolution of financial needs)
Secondary Outcome Measure Information:
Title
Financial Savings
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean S Edward, PhD, RN
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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