Financial StressNCT05876325
Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program
A study testing FINassist Patient and FINassist Caregiver in people with Financial Stress and Pediatric Cancer, run by Jean Edward at 1 site in United States.
Trial summary
The overall objective of this study was to develop and evaluate FINassist (Financial and Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology financial and legal navigation program. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Financial Stress, Pediatric Cancer
- What is being tested?
- FINassist Patient and FINassist Caregiver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregivers of patients who have any cancer or hematologic disorder diagnosis at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
- Patients with childhood cancers and/or hematologic disorders at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
- 18 years and older
Who cannot join
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky DanceBlue Pediatric Hematology/oncology clinic
Lexington, Kentucky, 40506
About this study
Official title: Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families
The overall objective of this study was to develop and evaluate FINassist (Financial and Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology financial and legal navigation program. The program leverages Medical Legal Partnerships to enhance cost of care conversations with pediatric oncology patients and caregivers. FINassist optimizes the team-based care model by integrating clinicians, social workers, financial navigators, and legal advocates who work in tandem to enhance cost of care conversations with patients and caregivers, identify and intervene on patient socio-legal needs, and advocate for system-level changes.
- Conditions
- Financial Stress, Pediatric Cancer
- Being tested
- FINassist Patient, FINassist Caregiver
- Keywords
- Financial toxicity, Hardship, Cost conversations, FINassist
- 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.
FINassist PatientOther
The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved
FINassist CaregiverOther
The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved
| Study group | Role | What they receive |
|---|---|---|
| Financial Navigation and Insurance Assistance (FINassist) | Experimental | FINassist is a comprehensive oncology financial and legal navigation program in oncology care Receives: Other: FINassist Patient; Other: FINassist Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants enrolled
Feasibility was defined as 60% or higher enrolled participant retention and resolution of financial or legal issue (based on existing oncology financial navigation studies)
Measured: 12 months
FINassist Adherence
Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution
Measured: through issue resolution up to 12 months
FINassist Retention
percentage of participants that complete both pre and post-intervention surveys
Measured: through study completion up to 12 months
FINassist Acceptability assessed by 5-item survey
Acceptability is measured using a 5 item post-intervention survey of relevance, helpfulness, convenience, recommendation to others, and value. Ratings on a scale from 0 to 10 where a higher score means greater acceptability
Measured: Post intervention at 12 months
Change in Total Financial Toxicity
Measured using the COmprehensive Score for financial Toxicity (COST) tool, a measure that describes the financial distress experienced by cancer patients. Scores range from 0-44 with a higher score representing better financial well-being.
Measured: Baseline and post intervention, approximately 12 weeks
Change in Participant Quality of Life (physical and mental)
Measured using the 10-item PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Global Health scale. A 7-item summary assessment of a child's self-reported health with higher scores representing better quality of life. Values range from 7-35, with higher scores representing better health.
Measured: Baseline and post intervention, approximately 12 weeks
Change in Participant Quality of Life (Depression)
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 and post intervention, approximately 12 weeks
Change in Participant Quality of Life (Anxiety)
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 and post intervention, approximately 12 weeks
Change in Patient-Provider Trust
Measured using the the Health Care Relationship (HCR) Trust Scale. The HCR-Trust scale is scored from 0 to 4 with a maximum score of 52. Higher scores represent more trust in healthcare providers
Measured: Baseline and post intervention, approximately 12 weeks
Resolution of Socio-legal Issue
Number of participants that resolved a legal or financial case as a result of FINassist
Measured: 12 months
Change in PROMIS Parent Proxy Global Health
used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Overall evaluation of physical, mental health, and social health.
Measured: Baseline and post intervention, approximately 12 weeks
Change in PROMIS Parent Proxy Pain Interference
used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
Measured: Baseline and post intervention, approximately 12 weeks
Change in PROMIS Parent Proxy Fatigue
used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion.
Measured: Baseline and post intervention, approximately 12 weeks
Secondary outcomes (1)
Number of Participants Receiving Financial Benefit
financial benefit defined as economic hardship avoided or decreased public/government income
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Apr 2021
- Primary completion1 Sep 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Financial StressStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jean Edward
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor-investigator, Jean Edward, University of Kentucky
- Investigators
- Jean Edward, PhD, RN, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876325
- Sponsor's protocol ID
- 57238
- Status last verified
- Jul 2024
- First submitted
- 16 May 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Edward J, Northrip KD, Rayens MK, Welker A, O'Farrell R, Knuf J, Fariduddin H, Costich J, D'Orazio J. Financial-legal navigation reduces financial toxicity of pediatric, adolescent, and young adult cancers. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae025. doi: 10.1093/jncics/pkae025.
PubMed 38552323
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families
- ClinicalTrials.gov ID
- NCT05876325
- Acronym / sponsor ID
- 57238
- Conditions
- Financial Stress, Pediatric Cancer
- Keywords
- Financial toxicity, Hardship, Cost conversations, FINassist
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Jean EdwardUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 May 2023 (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 was to develop and evaluate FINassist (Financial and Insurance Navigation Assistance), a patient-centered, interdisciplinary team-based oncology financial and legal navigation program. The program leverages Medical Legal Partnerships to enhance cost of care conversations with pediatric oncology patients and caregivers. FINassist optimizes the team-based care model by integrating clinicians, social workers, financial navigators, and legal advocates who work in tandem to enhance cost of care conversations with patients and caregivers, identify and intervene on patient socio-legal needs, and advocate for system-level changes.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Financial Navigation and Insurance Assistance (FINassist) | Experimental | Other: FINassist Patient, Other: FINassist CaregiverFINassist is a comprehensive oncology financial and legal navigation program in oncology care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Caregivers of patients who have any cancer or hematologic disorder diagnosis at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
- Patients with childhood cancers and/or hematologic disorders at the DanceBlue Pediatric Hematology/oncology clinic at Kentucky Children's hospital
- 18 years and older
Key exclusion criteria (1 listed)
- Unable to provide consent
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 |
|---|---|---|
| FINassist PatientThe FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved | Other | Financial Navigation and Insurance Assistance (FINassist) |
| FINassist CaregiverThe FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved | Other | Financial Navigation and Insurance Assistance (FINassist) |
Primary outcome
Number of participants enrolled
Time frame: 12 months
Feasibility was defined as 60% or higher enrolled participant retention and resolution of financial or legal issue (based on existing oncology financial navigation studies)
FINassist Adherence
Time frame: through issue resolution up to 12 months
Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution
FINassist Retention
Time frame: through study completion up to 12 months
percentage of participants that complete both pre and post-intervention surveys
FINassist Acceptability assessed by 5-item survey
Time frame: Post intervention at 12 months
Acceptability is measured using a 5 item post-intervention survey of relevance, helpfulness, convenience, recommendation to others, and value. Ratings on a scale from 0 to 10 where a higher score means greater acceptability
Change in Total Financial Toxicity
Time frame: Baseline and post intervention, approximately 12 weeks
Measured using the COmprehensive Score for financial Toxicity (COST) tool, a measure that describes the financial distress experienced by cancer patients. Scores range from 0-44 with a higher score representing better financial well-being.
Change in Participant Quality of Life (physical and mental)
Time frame: Baseline and post intervention, approximately 12 weeks
Measured using the 10-item PROMIS® (Patient-Reported Outcomes Measurement Information System) Parent Proxy Global Health scale. A 7-item summary assessment of a child's self-reported health with higher scores representing better quality of life. Values range from 7-35, with higher scores representing better health.
Change in Participant Quality of Life (Depression)
Time frame: Baseline and post intervention, approximately 12 weeks
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.
Change in Participant Quality of Life (Anxiety)
Time frame: Baseline and post intervention, approximately 12 weeks
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.
Change in Patient-Provider Trust
Time frame: Baseline and post intervention, approximately 12 weeks
Measured using the the Health Care Relationship (HCR) Trust Scale. The HCR-Trust scale is scored from 0 to 4 with a maximum score of 52. Higher scores represent more trust in healthcare providers
Resolution of Socio-legal Issue
Time frame: 12 months
Number of participants that resolved a legal or financial case as a result of FINassist
Change in PROMIS Parent Proxy Global Health
Time frame: Baseline and post intervention, approximately 12 weeks
used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Overall evaluation of physical, mental health, and social health.
Change in PROMIS Parent Proxy Pain Interference
Time frame: Baseline and post intervention, approximately 12 weeks
used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
Change in PROMIS Parent Proxy Fatigue
Time frame: Baseline and post intervention, approximately 12 weeks
used to measure child QOL (when applicable), with summary scores for proxy measures of global health, pain interference, and fatigue Range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion.
1 secondary outcome
Number of Participants Receiving Financial Benefit
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Derived from this study: PubMed 38552323Edward J, Northrip KD, Rayens MK, Welker A, O'Farrell R, Knuf J, Fariduddin H, Costich J, D'Orazio J. Financial-legal navigation reduces financial toxicity of pediatric, adolescent, and young adult cancers. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae025. doi: 10.1093/jncics/pkae025.
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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. This study is not recruiting at the moment.
Jean Edward, PhD, RN principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FINassist Patient and FINassist Caregiver in people with Financial Stress and Pediatric Cancer, run by Jean Edward 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 1 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: finished, as of the sponsor's last update on 22 Jul 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants enrolled (time frame: 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05876325, which also lists 1 linked publication.
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 22 Jul 2024.