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

University of Louisville

Summary

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.

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…

Eligibility

Age range: 18–39 years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Interventions

Other
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.
Other
Oncology Financial and Legal Navigation (OFLN) Standard
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.
Other
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/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.

Location

University of Louisville-Brown Cancer Center
Louisville, Kentucky

Description

Eligibility

Age range

18–39 years

Sex

All

Healthy volunteers

Detailed criteria

Interventions

Other

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.

Other

Oncology Financial and Legal Navigation (OFLN) Standard

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.

Other

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/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.