Behaviors and Mental Disorders

All Conditions

Financial Stress

Stress, Psychological

Behavioral Symptoms

Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete:

* Baseline survey in-person, by telephone, or virtually.
* PediRISE program orientation with study team member, in-person or virtual.
* Optional meeting with certified benefits counselor.
* Receive fixed funds twice a month for 6 months.
* Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.
* End of study survey.

Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete:

* Baseline survey in-person, by telephone, or virtually, and orientation with study team member.
* Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.
* End of study survey.

A centrally administered, income-poverty targeted intervention that includes twice-monthly direct provision of unrestricted cash transfers along with benefits counseling to mitigate the risk of loss of means-tested benefits. Funds will be dispersed to families via provided debit card or through personal banking, PayPal, or Venmo.

PediRISE Resource Program

Kira Bona, MD, MPH

The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program.

The names of the study groups in this research study are:

* PediRISE Program Group
* Usual Care Group

This is a pilot, multi-center, randomized research study for the feasibility of the administration of the PediRISE program among 40 poverty exposed children with newly diagnosed cancer. Randomization means there is an equal chance of being assigned to the PediRISE Program Group or the Usual Care Group.

Study procedures include screening for eligibility, study visits, and completion of surveys and questionnaires.

Participation in this study will last for about 6-months.

It is expected that about 40 pediatric participants with parents/guardians will take part in this research study.

This study is being supported by grants from the American Cancer Society and the Children's Cancer Research Fund.

PediRISE Feasibility

Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Dr. Kira Bona. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Feasibility of intervention is defined as \>75% of screened participants consent to randomization.

Feasibility of the intervention is defined as \<20% of randomized participants who do not complete 6-month survey in PediRiSE Program group.

Feasibility of the intervention is defined as \<20% of randomized participants who do not complete 6-month survey in Usual Care Group.

American Cancer Society, Inc.

Children's Cancer Research Fund

Dana-Farber Cancer Institute

Principal Investigator

Neoplasms

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Active navigation with the study-based financial navigator scheduling four check-in meetings throughout the study with the participant. All participants will complete an assessment at baseline, 3 months and 6 months and be invited to participate in an optional interview after the 6-month assessment.

Ad hoc navigation in which participant is provided study-based financial navigator to contact as needed. All participants will complete an assessment at baseline, 3 months and 6 months and be invited to participate in an optional interview after the 6-month assessment.

No access to a study-based financial navigator, but access to a national hotline through the Leukemia \& Lymphoma Society. All participants will complete an assessment at baseline, 3 months and 6 months and be invited to participate in an optional interview after the 6-month assessment.

Providing financial navigation to blood cancer survivors.

Providing financial navigation via active navigation, ad hoc navigation or no study-based navigation.

Susan K Parsons, MD, MRP

Young adult cancer survivors (18-39y) are at increased risk of financial distress. This study seeks to better understand the financial challenges experienced by these individuals via quantitative serial assessments, study-based financial navigator encounters and an end of study qualitative interview.

This fully remote, multi-site study will evaluate the role of financial navigators in relieving financial distress in young adults (18-39y) who have completed treatment for blood cancer at least three years ago. Serial Assessments at study entry, 3-months, and 6-months measure financial distress measured using the study's primary outcome measure the Personal Financial Wellness Scale™ (PFW) (see below), hypothesized effect modifiers (emotional distress, self-efficacy, cognitive functioning), as well as care seeking, household finances and insurance characteristics. Randomization will occur following completion of baseline measures (see below for description of study arms). In addition to a formal evaluation of the intervention at 3- and 6-months, an optional interview will occur following the 6-month assessment/navigation intervention period to gain further insight from participants about the acceptability of the intervention. For ethical considerations related to the topic of study, all participants will be provided with the Leukemia \& Lymphoma Society's information specialist hotline.

This is a multi-site, three-arm, financial navigation intervention

Financial Navigation Study Among Young Adult Blood Cancer Survivors

Evaluating the Role of Financial Navigation in Alleviating Financial Distress Among Young Adult Survivors of Blood Cancer

To evaluate the change in financial distress associated with randomization group assignment from baseline to 6-month follow up as measured by the 8-item Personal Financial Wellness Scale (PFW). The PFW scores range from 1-10 where lower scores indicate greater financial distress.

As part of Aim 1, we will explore whether changes in financial distress (baseline to 6-months) are moderated by emotional distress, self-efficacy, and cognitive functioning, as measured by Patient-Reported Measurement Information System (PROMIS) 4-item short forms for emotions distress (depression and anxiety) and self-efficacy, as well as the 4-item cognitive functioning scale from the Quality of Life in Neurological Disorders (Neuro-Qol) battery. For each of these short forms, high scores connote better functioning.

The Leukemia and Lymphoma Society

Tufts Medical Center

Quality of Life

Patients only participated in financial navigation program.

Patients and their caregivers participated as a dyad in financial navigation program.

The CC Links intervention is built on a platform of interdisciplinary team-based science, which ensured that the financial navigator worked closely with other members of the healthcare team including oncologists, nurses, transplant coordinators, social workers, and case managers, to help enhance financial hardship screening and connect survivors and caregivers with financial assistance services.

CC Links

Jean S Edward, PhD, RN

This trial is a mixed-methods, non-randomized design guided by the Consolidated Framework for Implementation Research (CFIR) to develop, implement, and evaluate Coverage and Cost-of-Care Links (CC Links) -a novel financial navigation intervention for hematologic cancer survivors and their caregivers.

The CC Links intervention included an oncology financial navigator who worked in the Hematology-Oncology Clinic. The navigator's functions included: screening for financial hardship to identify unmet financial needs (using the Comprehensive Score for Financial Toxicity (COST) and National Comprehensive Cancer Network's Distress Thermometer; initiating cost of care conversations; providing cost of care estimates; ensuring adequate health insurance coverage and assisting with applying for additional coverage; assisting with internal financial assistance program applications; connecting survivors/caregivers with disease specific resources and other external assistance programs; coordinating discharge planning; referring survivors to social workers and other staff/resources as needed; and, coordinating financial assistance services as survivors/caregivers transition between outpatient and inpatient settings.

Coverage and Cost-of-Care (CC) Links- Financial Navigation Program

Coverage and Cost-of-Care Links Financial Navigation Program in Hematology and Blood and Bone Marrow Transplantation (BMT)

"Coping behaviors" was measured using a series of 9 yes/no items that first assess whether any recommended cancer care was skipped for any reason (yes/no), and then whether the reason for not receiving the care that they or their doctor believed necessary was due to any of 8 listed reasons (yes/no for each). Typical reasons included 'Couldn't afford care,' 'Insurance company wouldn't approve or pay for care,' and 'Had problems getting to the doctor's office.' The sum of the number of yes responses is the total score, with higher scores indicating greater coping behaviors in response to financial hardship. The items in this scale are from the Medical Expenditure Panel Survey - Experiences with Cancer Survivorship Survey (MEPS-ECSS).

"Material conditions" was measured using 8 items (6 from the Medical Expenditure Panel Survey: Experiences with Cancer Survivorship Supplement (MEPS-ECSS) and 2 from demographic survey) that measure the financial condition of the participant with cancer and their family. Six of the items are yes/no and these include questions on borrowing money or go into debt, filing for bankruptcy, and concerns about having to pay large medical bills because of the cost of cancer treatment. The remaining two items are ordinal and measure the amount of debt related to cancer costs (options range from $0 to $100,00+), and the how they perceive their household's income currently (choices range from 'living comfortably on present income' to 'finding it very difficult on present income'). The latter two items are rescaled to 0-1 variables, so they have the same ranges as the yes/no items and are summed to create the total score. Higher scores indicate greater financial hardship.

Psychological response (i.e. financial toxicity) was 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.' Sample items include 'My out-of-pocket expense are more than I thought they would be' and 'I am frustrated that I cannot work or contribute as much as I usually do.' Lower values indicate greater financial toxicity.

Health-related QOL was measured using four Patient-Reported Outcomes Measurement Information System (PROMIS) scales.xx Each of these were scored and standardized by submitting the raw values to the HealthMeasures scoring service. We used the standardized values of the total scores throughout the analysis for this study. The four scales include the PROMIS physical health and emotional health subscales (from the 10-item PROMIS Scale v1.2 - Global Health),xx the 4-item PROMIS- Anxiety Short Form, and the 6-item PROMIS-Depression Short Form. The physical (physical health, function, pain, and fatigue items) and emotional health (QOL, mental health, social activities, and emotional problem items) subscales are each based on 4 items, with higher scores indicating a more positive health self-assessment. For the anxiety and depression scales, higher scores indicate a greater manifestation of symptoms.

Distress was measured using the National Comprehensive Cancer Network's (NCCN) Distress Thermometer and its accompanying 40-item problem list. A cutoff score of 4 indicated clinically elevated distress levels

Amount of money saved per patient including grants and financial assistance received, total charges, financial assistance adjustments, insurance payments, and insurance charges.

Jean Edward

Associate Professor

Rare Diseases

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Participants will be randomized in a 1:1 ratio and stratified according to treatment group and household material hardship (HMH) severity group and participant parents/guardians will complete:

* Remote baseline visit with introduction to PediCARE intervention by central study team
* Parent completion of baseline survey.
* Receipt of monthly PediCARE resource provisions x 6-months.
* Parent completion of 3-month follow-up survey.
* Parent completion of 6-month follow up survey and end of intervention period.

Participants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity group and participant parent/guardians will complete:

* Remote baseline visit
* Parent completion of baseline survey.
* Receipt of site-specific routine supportive care x6-month study period
* Parent completion of 3-month follow-up survey
* Parent completion of 6-month follow-up survey

A household material hardship intervention with monthly, direct provision of groceries and transportation. Resources will be centrally administered by the Dana-Farber Cancer Institute study team.

PediCARE Intervention

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.

The names of the intervention groups in this research study are:

* Usual supportive care
* PediCARE + usual supportive care

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma.

Participants will be randomized into one of two groups: Usual Supportive Care vs. PediCARE + Usual Supportive Care. Randomization means a participant is placed into a group by chance.

Participation in this research study is expected to last 6-months.

It is expected about 130 people will participate in this research study.

PediCARE Health Equity Intervention in High-Risk Neuroblastoma

A Randomized Phase II Trial Evaluation of the Addition of the Pediatric Cancer Resource Equity (PediCARE) Health Equity Intervention to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to the study PI Dr. Kira Bona. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

As measured by the Kessler-6 Psychological Distress Scale (K6), a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores \> or = 7 suggest "high" distressed and those \> or = 13 meet criteria for serious or debilitating psychological distress. A t-test of differences in mean change scores of parent/guardian psychological distress from T1 (baseline) to T2 (3 months) will be used to compare across PediCARE and usual supportive care arms. The distribution of parent psychological distress scores across PediCARE and usual supportive care arms will also be descriptively characterized. The descriptive analyses will be intention-to-treat, defined as all randomized participants with at least one post-baseline contact or follow-up measure.

Feasibility of conducting a centrally-administered companion health equity intervention study among COG trial-enrolled participants will be described using proportions and 95% confidence intervals. Successful feasibility is defined as \>75% consent to participation and randomization and \<20% attrition. Feasibility metrics will be collected and monitored in real time throughout the duration of the study (about 5 years). An interim analysis for early stopping will also be conducted halfway through accrual (n=40 participants) to assess futility of the feasibility endpoint.

Household Material Hardship (HMH) information will via parent/guardian-completed survey instruments using standardized measures of housing, food, utility, and transportation insecurity. HMH scores will be calculated based on parent/guardian responses and will range from 0-4 based on the number of discrete areas of insecurity endorsed by participants. A t-test of differences in mean HMH change scores from T1 (baseline) to T2 (month 3) will be used to compare across PediCARE and usual supportive care arms. Investigators will also characterize the distribution between T1 and T2 HMH scores across PediCARE and usual supportive care arms on the ordinal scale from 0 to 4 using a chi-square test.

Patients only participated in FINassist program

Caregivers of minor patients only participated in FINassist program

The FINassist intervention provides access to social, financial and legal services over the duration of 12 months or until issues are resolved

FINassist

Jean Edward, PhD, RN

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.

Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program

Leveraging Medical Legal Partnerships to Enhance Patient-Centered, Team-Based Cost Conversations With Pediatric Oncology Patients and Families

Feasibility is defined by number of participants enrolled

Adherence is defined by the percentage of participants that maintain communication with the team and provide documents necessary for issue resolution

percentage of participants that complete both pre and post-intervention surveys

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 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 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.

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 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 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

Number of participants that resolved a legal or financial case as a result of FINassist

financial benefit defined as economic hardship avoided or decreased public/government income

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PediRISE Feasibility	NCT06283251	Pediatric Cance... Financial Stres... Financial Hards... Disparities	PediRISE Resour...	- 17 Years	Dana-Farber Cancer Institute
Financial Navigation Study Among Young Adult Blood Cancer Survivors	NCT05620979	Survivorship Cancer Financial Stres...	Providing finan...	18 Years - 39 Years	Tufts Medical Center
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program	NCT05465577	Financial Stres... Hematologic Can... Survivorship	CC Links	18 Years - 100 Years	University of Kentucky
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program	NCT05465577	Financial Stres... Hematologic Can... Survivorship	CC Links	18 Years - 100 Years	University of Kentucky
PediCARE Health Equity Intervention in High-Risk Neuroblastoma	NCT06335745	Neuroblastoma High-risk Neuro... Pediatric Cance... Disparities Financial Stres... Poverty	PediCARE Interv...	0 Years - 17 Years	Dana-Farber Cancer Institute
Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program	NCT05876325	Financial Stres... Pediatric Cance...	FINassist FINassist	18 Years - 65 Years	University of Kentucky
Financial and Insurance Assistance- Oncology Financial and Legal Navigation Program	NCT05876325	Financial Stres... Pediatric Cance...	FINassist FINassist	18 Years - 65 Years	University of Kentucky

Spots Global Cancer Trial Database for financial stress