Financial Navigation for Economic Burden in Cancer
(OFLN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Jean Edward, PhD, RN, FAAN
Principal Investigator
University of Louisville-Brown Cancer Center
Are You a Good Fit for This Trial?
This trial is for adolescents and young adults who have been diagnosed with cancer and are experiencing financial or legal challenges related to their illness. Participants must be able to take part in navigation services.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive either the Stepped or Standard Oncology Financial and Legal Navigation (OFLN) intervention based on randomization
Follow-up
Participants are monitored for changes in financial toxicity, quality of life, and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Oncology Financial and Legal Navigation (OFLN) Standard
- Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity
- Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity
Trial Overview
The study compares different levels of support (low, standard, high-intensity) from a financial and legal navigation program designed to help cancer patients manage money-related stress. Participants are randomly assigned to these groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Louisville
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
James Graham Brown Cancer Center
Collaborator
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