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.
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
Cognitive impairments that would interfere with participation
Unable to read and speak English or Spanish
Parallel
Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity
Other interventionBaseline 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.
Oncology Financial and Legal Navigation (OFLN) Standard
Other interventionOnce 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.
Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity
Other interventionOnce 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.
Change in Financial Toxicity: Psychological Response
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.
Implementation Outcomes
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.
Change in Financial Toxicity: Material Burden
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.
Change in Financial Toxicity: Coping Burden
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.
Change in Cost-related Health Literacy
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?"
Change in Participant Quality of Life
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.
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University of Louisville
Lead sponsor
National Institutes of Health (NIH)
Collaborator
James Graham Brown Cancer Center
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
