Implementing Stepped Financial and Legal Navigation to Mitigate Financial Toxicity in Adolescent and Young Adult Cancer Patients Oncology Financial and Legal Navigation (OFLN) (OFLN)
The overall objective of this study is to test the effectiveness and implementability of stepped Oncology Financial and Legal Navigation (OFLN) in a noninferiority randomized controlled trial (RCT) using a hybrid type 1 (effectiveness-implementation) design.
Study Overview
Status
Detailed Description
The purpose of this study is to help with any financial and legal needs you may have, which will be provided through an Oncology Financial and Legal Navigation (OFLN) program. This is a randomized study, which means that after you agree to participate in this study, you will be randomly selected, like a flip of a coin, to receive either 1) OFLN A - Stepped Intervention or 2) OFLN B - Standard Intervention. The Stepped Intervention will provide a low and high intensity OFLN. The Standard Intervention will only provide high intensity OFLN. The low- intensity OFLN will include a personalized self-managed navigation program, while the high intensity OFLN will be guided by a navigator. Regardless of which OFLN intervention you are assigned to, you will receive assistance with your financial/legal needs. By participating in this program, you will be asked to work closely with study team at the University of Louisville (UofL) Health Brown Cancer Center and Triage Cancer-a financial/legal navigation program to help address your needs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jean Edward, PhD, RN, FAAN
- Phone Number: 502-852-4356
- Email: jean.edward@louisville.edu
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40202
- University of Louisville-Brown Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Newly diagnosed with cancer within the past 12 months
- Able to read and speak English or Spanish
- Actively receiving healthcare at the University of Louisville
Exclusion Criteria:
- Cognitive impairments that would interfere with participation
- Unable to read and speak English or Spanish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Oncology Financial and Legal Navigation (OFLN) Stepped Arm
Once randomized to the stepped Oncology Financial and Legal Navigation (OFLN) intervention arm, patients with a lower financial toxicity at baseline will be assigned to the low-intensity OFLN and patients with high financial toxicity will be assigned to the high-intensity OFLN. |
Baseline needs will be reviewed by Triage Cancer navigators who will build and personalize a self-managed navigation program and mail introductory packets and resource materials to participant along with an email link with personalized program which includes a customized package of Triage Cancer's educational resources (e.g., webinars, quick guides, interactive tools. Participants will have roughly 4 weeks to complete their program, lasting ~4 hours, and any self-directed activities. Completion verification and engagement tracking questions are included in weekly check-in surveys to monitor progress. Following each 6-week screening, participants whose financial toxicity (FT) scores remain stable or improve will continue to receive an email with resources customized to newly identified needs until 30 weeks. Participants whose financial toxicity (FT) worsens and who meet criteria for stepping up following screenings (within the 30-week period) will be stepped into the high intensity arm. Once enrolled in the high-intensity Oncology Financial and Legal Navigation (OFLN) arm, participants will be contacted by Triage Cancer navigators via email to schedule an initial phone consultation to review needs and collect pertinent information on insurance and employment, income, billing and other details to help connect participants with appropriate resources. Triage Cancer navigators will meet with all enrolled participants for a minimum of 6 phone/videocall appointments starting with an initial consultation at baseline and follow-up appointments every 6 weeks following financial toxicity screenings, and as needed. All participants will receive navigation services for 30 weeks. Additional intensive legal services (i.e., legal counseling or representation) that require a jurisdiction-specific licensed lawyers will be provided by the research team's supervising attorney. |
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Active Comparator: Oncology Financial and Legal Navigation (OFLN) Standard
Patients randomized to the standard Oncology Financial and Legal Navigation (OFLN) arm will receive standard navigation services which includes access to a virtual, navigator-led program. |
Once randomized in the standard Oncology Financial and Legal Navigation (OFLN) arm, participants will be contacted by Triage Cancer navigators via email to schedule an initial phone consultation to review needs and collect pertinent information on insurance and employment, income, billing and other details to help connect participants with appropriate resources. Triage Cancer navigators will meet with all enrolled participants for a minimum of 6 phone/video call appointments starting with an initial consultation at baseline and follow-up appointments every 6 weeks following financial toxicity screenings, and as needed. All participants will receive navigation services for 30 weeks. Additional intensive legal services (i.e., legal counseling or representation) that require a jurisdiction-specific licensed lawyers will be provided by the research team's supervising attorney. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Financial Toxicity: Psychological Response
Time Frame: From baseline to 12-, 30- (primary), and 48-weeks; and also measured every 6 weeks as screener
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Financial toxicity (psychological response) will be 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. Lower values indicate greater financial toxicity. |
From baseline to 12-, 30- (primary), and 48-weeks; and also measured every 6 weeks as screener
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Implementation Outcomes
Time Frame: Measured at 30-weeks and 48-weeks
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Intervention acceptability, appropriateness and feasibility will be measured using the Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM) and Feasibility of Intervention Measure (FIM) with 12 items total, 3 subscales (4 items per subscale). Each item is rated on a 5-point Likert scale, with each subscale scored by summing the four items to yield a possible score ranging from 4 to 20. Higher scores indicate greater intervention acceptability, appropriateness, or feasibility, respectively. |
Measured at 30-weeks and 48-weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Financial Toxicity: Material Burden
Time Frame: Baseline to 12-, 30-, and 48-weeks
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Financial toxicity (material burden) will be measured using the 15-item Economic Strain and Resilience in Cancer (ENRICh) scale which assesses overall financial toxicity across three subdomains: material burden, coping burden, and psychological distress. Items are scored on a 0-10 scale, with subdomain scores ranging from 0 to 10, where 0 indicates the least financial burden and 10 indicates the greatest financial burden. Higher material burden scores indicate greater financial hardship, including greater financial depletion related to out-of-pocket costs, use of savings, debt, and lost income. |
Baseline to 12-, 30-, and 48-weeks
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Change in Financial Toxicity: Coping Burden
Time Frame: Baseline to 12-, 30- and 48-weeks
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Financial toxicity (coping burden) will be measured using the 15-item Economic Strain and Resilience in Cancer (ENRICh) scale which assesses overall financial toxicity across three subdomains: material burden, coping burden, and psychological distress. Items are scored on a 0-10 scale, with subdomain scores ranging from 0 to 10, where 0 indicates the least financial burden and 10 indicates the greatest financial burden. Higher material burden scores indicate greater financial hardship, including greater financial depletion related to out-of-pocket costs, use of savings, debt, and lost income. |
Baseline to 12-, 30- and 48-weeks
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Change in Cost-related Health Literacy
Time Frame: From baseline to 12-, 30-, and 48-weeks
|
Cost-related health literacy will be measured using the 21-item Health Insurance Literacy Measure (HILM), which assesses confidence and health insurance-related behaviors related to choosing and using health insurance. The HILM includes four subscales: confidence in choosing health insurance, comparing health insurance plans, confidence in using health insurance, and being proactive in using health insurance. Items are rated on 4-point ordinal scales, with a total score ranging from 21 to 84. Higher scores indicate greater health insurance literacy, including greater confidence and greater likelihood of engaging in health insurance-literate behaviors. Cost-related health literacy will also be measured using a 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?" |
From baseline to 12-, 30-, and 48-weeks
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Change in Participant Quality of Life
Time Frame: Baseline to 12-, 30-, and 48-weeks.
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Quality of life will be assessed using the 7-item Functional Assessment of Cancer Therapy-General (FACT-G7), which assesses physical, emotional, and functional well-being over the past 7 days. Items are rated on a 5-point Likert-type scale from 0 (not at all) to 4 (very much), with negatively worded items reverse-scored. Total scores range from 0 to 28, with higher scores indicating better quality of life. |
Baseline to 12-, 30-, and 48-weeks.
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Change in Participant Quality of Life (Anxiety)
Time Frame: Baseline to 12-, 30- and 48-weeks
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Anxiety was measured using the 4-item Patient-Reported Outcomes Measurement Information System PROMIS® Anxiety short form. Scores range from 4 to 20. Higher scores indicate more of the construct being measured. |
Baseline to 12-, 30- and 48-weeks
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Changes in Participant Quality of Life (Depression)
Time Frame: Baseline to 12-, 30- and 48-weeks.
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Depression was measured using the 6-item Patient-Reported Outcomes Measurement Information System PROMIS® Depression Short Form. Scores range from 6 to 30. Higher scores indicate more of the construct being measured. |
Baseline to 12-, 30- and 48-weeks.
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Change in Distress
Time Frame: Baseline to 12-, 30-, and 48-weeks. Also used as a 6-week screener.
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Distress will be measured using the National Comprehensive Cancer Network's (NCCN) 1-item Distress Thermometer and its accompanying 39-item problem list. A cutoff score of 4 indicates clinically elevated distress levels. |
Baseline to 12-, 30-, and 48-weeks. Also used as a 6-week screener.
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Financial Savings
Time Frame: Measured at 30- and 48-weeks.
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Financial savings will be measured by assessing the amount of money saved per patient as result of participating in the intervention including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges. |
Measured at 30- and 48-weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jean Edward, PhD, RN, FAAN, University of Louisville-Brown Cancer Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26.0292 OFLN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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