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

NCT07849699 | Not Yet Recruiting DMC

• 1 other identifier: 26.0292 OFLN
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adolescent and Young Adult Cancer; Financial Toxicity

Keywords

Financial toxicity; Adolescent and Young Adult; Oncology financial and legal navigation; Hardship

Outcome Measures

Primary Outcomes (2)

• 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

• 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. Higher scores indicate greater intervention acceptability, appropriateness and feasibility.

  Measured at 30-weeks and 48-weeks

Secondary Outcomes (8)

• Change in Financial Toxicity: Material Burden

  Baseline to 12-, 30-, and 48-weeks

• Change in Financial Toxicity: Coping Burden

  Baseline to 12-, 30- and 48-weeks

• Change in Cost-related Health Literacy

  From baseline to 12-, 30-, and 48-weeks

• Change in Participant Quality of Life

  Baseline to 12-, 30-, and 48-weeks.

• Change in Participant Quality of Life (Anxiety)

  Baseline to 12-, 30- and 48-weeks

Study Arms (2)

OFLN Stepped Arm

EXPERIMENTAL

Once randomized to the stepped 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.

Other: OFLN Stepped: Low Intensity; Other: OFLN Stepped: High-Intensity

OFLN Standard

ACTIVE COMPARATOR

Patients randomized to the standard OFLN arm will receive standard navigation services which includes access to a virtual, navigator-led program.

Other: OFLN Standard

Interventions

OFLN Stepped: Low Intensity OTHER

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.

OFLN Stepped Arm

OFLN Standard OTHER

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.

OFLN Standard

OFLN Stepped: High-Intensity OTHER

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.

OFLN Stepped Arm

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairments that would interfere with participation
• Unable to read and speak English or Spanish

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• James Graham Brown Cancer Center: collaborator
• University of Louisville: lead

Study Sites (1)

University of Louisville-Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Jean Edward, PhD, RN, FAAN

  University of Louisville-Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Edward, PhD, RN, FAAN

CONTACT

502-852-4356; jean.edward@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Associate Dean for Faculty Development and Mentoring School of Nursing; Deputy Director of Nursing Research, Brown Cancer Center

Model Details: The OFLN intervention will used a stepped-intensity model to provide low- and high-intensity navigation services.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)