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NOT YET RECRUITING
NCT07849699
NA

Implementing Stepped Financial and Legal Navigation to Mitigate Financial Toxicity in Adolescent and Young Adult Cancer Patients Oncology Financial and Legal Navigation (OFLN)

Sponsor: University of Louisville

View on ClinicalTrials.gov

Summary

The overall objective of this study is to test the effectiveness and implementability of stepped OFLN in a noninferiority randomized controlled trial (RCT) using a hybrid type 1 (effectiveness-implementation) design.

Key Details

Gender

All

Age Range

18 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

294

Start Date

2027-02-01

Completion Date

2031-06-01

Last Updated

2026-09-30

Healthy Volunteers

No

Interventions

OTHER

OFLN Stepped: Low Intensity

Patients' baseline needs will be reviewed by Triage Cancer navigators who will build and personalize their self-managed navigation program and mail introductory packets and resource materials to patient. Pt will receive an email link to access their personalized program. The program will include a customized package of Triage Cancer's educational resources (e.g., webinars, quick guides, interactive tools. Patients 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 FT scores remain stable or improve will continue to receive an email with resources customized to newly identified needs until 30 weeks. Patients whose FT worsens and who meet criteria for stepping up following screenings (within the 30-week period) will be stepped into the high intensity arm.

OTHER

OFLN Standard

Once randomized in the standard OFLN arm, patients 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 patients with appropriate resources. Triage Cancer navigators will meet with all enrolled patients for a minimum of 6 phone/videocall appointments starting with an initial consultation at baseline and follow-up appointments every 6 weeks following FT screenings, and as needed. All patient 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.

OTHER

OFLN Stepped: High-Intensity

Once enrolled in the high-intensity OFLN arm, patients 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 patients with appropriate resources. Triage Cancer navigators will meet with all enrolled patients for a minimum of 6 phone/videocall appointments starting with an initial consultation at baseline and follow-up appointments every 6 weeks following FT screenings, and as needed. All patient 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.

Locations (1)

University of Louisville-Brown Cancer Center

Louisville, Kentucky, United States