[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658192":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":57,"studyPopulation":49,"armGroups":58,"interventions":72,"overallOfficials":84,"centralContacts":89,"locations":94,"responsibleParty":107,"collaborators":110,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":49,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":138,"overallStatus":143,"whyStopped":49,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"University of Louisville","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":49},[9,13],{"measure":10,"description":11,"timeFrame":12},"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.","From baseline to 12-, 30- (primary), and 48-weeks; and also measured every 6 weeks as screener",{"measure":14,"description":15,"timeFrame":16},"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.","Measured at 30-weeks and 48-weeks",[18,22,26,30,34,37,41,45],{"measure":19,"description":20,"timeFrame":21},"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.","Baseline to 12-, 30-, and 48-weeks",{"measure":23,"description":24,"timeFrame":25},"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.","Baseline to 12-, 30- and 48-weeks",{"measure":27,"description":28,"timeFrame":29},"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.\n\nCost-related health literacy will also be measured using a single item, yes\u002Fno 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",{"measure":31,"description":32,"timeFrame":33},"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.","Baseline to 12-, 30-, and 48-weeks.",{"measure":35,"description":36,"timeFrame":25},"Change in Participant Quality of Life (Anxiety)","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.",{"measure":38,"description":39,"timeFrame":40},"Changes in Participant Quality of Life (Depression)","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.",{"measure":42,"description":43,"timeFrame":44},"Change in Distress","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.",{"measure":46,"description":47,"timeFrame":48},"Financial Savings","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.",null,{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":49,"timePerspective":49,"maskingInfo":55},"RANDOMIZED","PARALLEL","The Oncology Financial and Legal Navigation (OFLN) intervention will used a stepped-intensity model to provide low- and high-intensity navigation services.","SUPPORTIVE_CARE",{"masking":56,"maskingDescription":49,"whoMasked":49},"NONE","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\u002Flegal 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\u002Flegal navigation program to help address your needs.",[59,66],{"label":60,"type":61,"description":62,"interventionNames":63},"Oncology Financial and Legal Navigation (OFLN) Stepped Arm","EXPERIMENTAL","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.",[64,65],"Other: Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity","Other: Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity",{"label":67,"type":68,"description":69,"interventionNames":70},"Oncology Financial and Legal Navigation (OFLN) Standard","ACTIVE_COMPARATOR","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.",[71],"Other: Oncology Financial and Legal Navigation (OFLN) Standard",[73,77,80],{"type":6,"name":74,"description":75,"armGroupLabels":76,"otherNames":49},"Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity","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.",[60],{"type":6,"name":67,"description":78,"armGroupLabels":79,"otherNames":49},"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\u002Fvideo 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.",[67],{"type":6,"name":81,"description":82,"armGroupLabels":83,"otherNames":49},"Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity","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\u002Fvideocall 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.",[60],[85],{"name":86,"affiliation":87,"role":88},"Jean Edward, PhD, RN, FAAN","University of Louisville-Brown Cancer Center","PRINCIPAL_INVESTIGATOR",[90],{"name":86,"role":91,"phone":92,"phoneExt":49,"email":93},"CONTACT","502-852-4356","jean.edward@louisville.edu",[95],{"facility":87,"status":49,"city":96,"state":97,"zip":98,"country":99,"countryCode":100,"cosmosGeoPoint":101,"geoPoint":106,"contacts":49},"Louisville","Kentucky","40202","United States","US",{"type":102,"coordinates":103},"Point",[104,105],-85.75941,38.25424,{"lat":105,"lon":104},{"type":88,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"Jean Edward","Professor, Associate Dean for Faculty Development and Mentoring School of Nursing; Deputy Director of Nursing Research, Brown Cancer Center",[111,114],{"name":112,"class":113},"National Institutes of Health (NIH)","NIH",{"name":115,"class":6},"James Graham Brown Cancer Center","100658192","implementing-stepped-financial-and-legal-navigation-to-mitigate-financial-toxicity-in-adolescent-and-young-adult-cancer-patients-oncology-financial-and-legal-navigation-ofln-100658192",false,"NCT07849699","Implementing Stepped Financial and Legal Navigation to Mitigate Financial Toxicity in Adolescent and Young Adult Cancer Patients Oncology Financial and Legal Navigation (OFLN)","OFLN","Inclusion Criteria:\n\n* Newly diagnosed with cancer within the past 12 months\n* Able to read and speak English or Spanish\n* Actively receiving healthcare at the University of Louisville\n\nExclusion Criteria:\n\n* Cognitive impairments that would interfere with participation\n* Unable to read and speak English or Spanish","ALL","18 Years","39 Years",{"count":127,"type":128},294,"ESTIMATED","INTERVENTIONAL",[131],"NA","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.",[134,135,136,137],"Financial Toxicity","Cancer","Adolescent","Young Adult Cancer Survivors",[139,140,141,142],"Financial toxicity","Adolescent and Young Adult","Oncology financial and legal navigation","Hardship","NOT_YET_RECRUITING","2026-09-30",{"date":146,"type":147},"2026-10-05","ACTUAL",{"date":149,"type":128},"2027-02-01",{"date":151,"type":128},"2031-06-01",{"name":5,"class":6},1]