Financial ToxicityOFLNNCT07849699
Implementing Stepped Financial and Legal Navigation to Mitigate Financial Toxicity in Adolescent and Young Adult Cancer Patients Oncology Financial and Legal Navigation (OFLN)
A study testing Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity, Oncology Financial and Legal Navigation (OFLN) Standard and Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity in people with Financial Toxicity and Cancer, run by University of Louisville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Financial Toxicity, Cancer, Adolescent
- What is being tested?
- Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity, Oncology Financial and Legal Navigation (OFLN) Standard and Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 294 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2027to 1 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairments that would interfere with participation
- Unable to read and speak English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Louisville-Brown Cancer Center
Louisville, Kentucky, 40202
About this study
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.
Read the detailed 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-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/legal 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/legal navigation program to help address your needs.
- Conditions
- Financial Toxicity, Cancer, Adolescent, Young Adult Cancer Survivors
- Being tested
- Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity, Oncology Financial and Legal Navigation (OFLN) Standard, Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity
- Keywords
- Financial toxicity, Adolescent and Young Adult, Oncology financial and legal navigation, Hardship
- Medical subject headings
- Financial Stress, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncology Financial and Legal Navigation (OFLN) Stepped: Low IntensityOther
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.
Oncology Financial and Legal Navigation (OFLN) StandardOther
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.
Oncology Financial and Legal Navigation (OFLN) Stepped: High-IntensityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity; Other: Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity |
| 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. Receives: Other: Oncology Financial and Legal Navigation (OFLN) Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (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: Measured at 30-weeks and 48-weeks
Secondary outcomes (8)
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.
Measured: Baseline to 12-, 30-, and 48-weeks
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.
Measured: Baseline to 12-, 30- and 48-weeks
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.
Cost-related health literacy will also be measured using a single item, yes/no 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?"
Measured: From baseline to 12-, 30-, and 48-weeks
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.
Measured: Baseline to 12-, 30-, and 48-weeks.
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.
Measured: Baseline to 12-, 30- and 48-weeks
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.
Measured: Baseline to 12-, 30- and 48-weeks.
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.
Measured: Baseline to 12-, 30-, and 48-weeks. Also used as a 6-week screener.
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: Measured at 30- and 48-weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial ToxicityStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The Oncology Financial and Legal Navigation (OFLN) intervention will used a stepped-intensity model to provide low- and high-intensity navigation services.
- Masking
- None (open label)
- Enrolment
- 294 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), James Graham Brown Cancer Center
- Responsible party
- Principal investigator, Jean Edward, University of Louisville
- Investigators
- Jean Edward, PhD, RN, FAAN, Principal investigator, University of Louisville-Brown Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849699
- Sponsor's protocol ID
- 26.0292 OFLN
- Acronym
- OFLN
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Stepped Financial and Legal Navigation to Mitigate Financial Toxicity in Adolescent and Young Adult Cancer Patients Oncology Financial and Legal Navigation (OFLN)
- ClinicalTrials.gov ID
- NCT07849699
- Acronym / sponsor ID
- OFLN / 26.0292 OFLN
- Conditions
- Financial Toxicity, Cancer, Adolescent, Young Adult Cancer Survivors
- Keywords
- Financial toxicity, Adolescent and Young Adult, Oncology financial and legal navigation, Hardship
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 294 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), James Graham Brown Cancer Center
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 30 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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-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/legal 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/legal navigation program to help address your needs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The Oncology Financial and Legal Navigation (OFLN) intervention will used a stepped-intensity model to provide low- and high-intensity navigation services.
| Arm | Type | Receives |
|---|---|---|
| Oncology Financial and Legal Navigation (OFLN) Stepped Arm | Experimental | Other: Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity, Other: Oncology Financial and Legal Navigation (OFLN) Stepped: High-IntensityOnce 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. |
| Oncology Financial and Legal Navigation (OFLN) Standard | Active comparator | Other: Oncology Financial and Legal Navigation (OFLN) StandardPatients 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Cognitive impairments that would interfere with participation
- Unable to read and speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oncology Financial and Legal Navigation (OFLN) Stepped: Low IntensityBaseline 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) Stepped Arm |
| Oncology Financial and Legal Navigation (OFLN) StandardOnce 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) Standard |
| Oncology Financial and Legal Navigation (OFLN) Stepped: High-IntensityOnce 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. | Other | Oncology Financial and Legal Navigation (OFLN) Stepped Arm |
Primary outcome
Change in Financial Toxicity: Psychological Response
Time frame: From baseline to 12-, 30- (primary), and 48-weeks; and also measured every 6 weeks as screener
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.
Implementation Outcomes
Time frame: Measured at 30-weeks and 48-weeks
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.
8 secondary outcomes
Change in Financial Toxicity: Material Burden
Time frame: Baseline to 12-, 30-, and 48-weeks
Change in Financial Toxicity: Coping Burden
Time frame: Baseline to 12-, 30- and 48-weeks
Change in Cost-related Health Literacy
Time frame: From baseline to 12-, 30-, and 48-weeks
Change in Participant Quality of Life
Time frame: Baseline to 12-, 30-, and 48-weeks.
Change in Participant Quality of Life (Anxiety)
Time frame: Baseline to 12-, 30- and 48-weeks
Changes in Participant Quality of Life (Depression)
Time frame: Baseline to 12-, 30- and 48-weeks.
Change in Distress
Time frame: Baseline to 12-, 30-, and 48-weeks. Also used as a 6-week screener.
Financial Savings
Time frame: Measured at 30- and 48-weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Edward, PhD, RN, FAAN principal investigator
University of Louisville-Brown Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oncology Financial and Legal Navigation (OFLN) Stepped: Low Intensity, Oncology Financial and Legal Navigation (OFLN) Standard and Oncology Financial and Legal Navigation (OFLN) Stepped: High-Intensity in people with Financial Toxicity and Cancer, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean Edward, PhD, RN, FAAN (502-852-4356, jean.edward@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Financial Toxicity: Psychological Response (time frame: From baseline to 12-, 30- (primary), and 48-weeks; and also measured every 6 weeks as screener). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.