Characterizing and Addressing Financial Toxicity in AYAs With Cancer

Study Overview
=================
Brief Summary
-----------------
The overall aims of this study are to address two important gaps in care for AYA cancer patients: 1) a financial toxicity measurement tool to assess AYA-specific needs, and 2) an intervention for mitigating financial toxicity in this population. Aim 1 involves adapting the COSTA measure and assessing the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. Aim 2 and 3 involve the development and pilot testing of our novel financial education/ navigation (FE/FN) intervention.

Detailed Description
-----------------
Financial toxicity is the harmful personal financial burden faced by patients due to healthcare needs. A prevalent adverse outcome of cancer therapy, financial toxicity is associated with poorer health outcomes and increased mortality in adults with cancer. Among cancer survivors, financial burden disproportionately impacts adolescents and young adults (AYA: 15 - 39 years). Lack of financial security, insurance gaps or under-insurance, and interruptions in education or careers caused by cancer therapy make AYA cancer survivors particularly vulnerable to financial burden. Financial toxicity of cancer care is an actionable factor impacting outcomes among vulnerable AYA populations. In order to improve outcomes and reduce the burden of care among these populations, targeted, appropriate measures and then, age-specific interventions are needed. The study includes the following aims: Aim 1 involves the adaptation of the COST measure and assessment of the psychometric properties of the measure for a racial/ethnically diverse group of AYAs. The study team will administer COST and additional AYA-specific financial toxicity candidate items to N=150 AYAs. The study will assess validity of original COST through confirmatory factor analysis; assess reliability through test/retest; conduct exploratory factor analysis on modified COST incorporating added items; and describe AYA-reported acceptability of AYA financial toxicity assessment. In Aim 2, an adapted FN/FE intervention will be adapted for a racial/ethnically diverse group of AYAs. 6 focus groups (6 - 8 per group) will be conducted with a diverse AYAs and caregivers, and brief stakeholder discussions to understand unique AYA FE/FN needs and inform intervention refinement. Aim 3 will include a pilot test of our novel FE/FN intervention to AYAs. A FE/FN intervention will be delivered to at least N=30 AYAs, and assess feasibility by evaluating program completion (6-months), participant-reported acceptability. Evidence of efficacy will be recorded by measuring improvement in average financial toxicity score between baseline and 6-month time points.

Official Title
-----------------
Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer

Conditions
-----------------
Cancer in Adolescence

Intervention / Treatment
-----------------
* Behavioral: Patient Financial Education / Navigation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AYA patient participants: Age 15 - 39 years old English or Spanish-speaking Diagnosed with cancer that required treatment within past 18 months Not currently on hospice care Caregiver/financial partner participants: Parent or financially-responsible adult of non-adult AYA (<18 years) OR Identified by the AYA as caregiver, parent, or partner who is financially-responsible or a financial partner for AYA Exclusion Criteria: Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 39 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: Participants who screen positive all move forward to receive the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient Financial Education / Navigation<br>Individuals who screen positive will all move forward to receive the intervention. This intervention includes partnering with community-based organizations to deliver financial education, connection to resources, and counseling tailored to individual patients and spouses for 6-months. | Behavioral: Patient Financial Education / Navigation<br>* The investigator anticipates that this will include a baseline financial assessment and educational content, likely using a virtual platform. Participants will be connected with a PAF case manager. There will be monthly follow-ups to the participant for 6-months to address any financial concerns through additional counseling/navigation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of (OR percentage of) participants who completed the intervention | This is to assess the feasibility of intervention completion. Intervention completion is defined as participants who have demonstrated contact with community partners at any time before the end of 6 months. | Up to 6 months | 
| Percentage of eligible participants who consented to be in study | This is to measure interest and the need for help by community partners that can provide patient financial education and navigation. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comprehensive Score of Financial Toxicity (COST measure) | The COST is a patient-reported outcome measure that describes the financial distress experienced by cancer patients. It is a 11-item questionnaire with a score range of 0-44. Lower COST values indicate higher toxicity. Higher scores indicate lower financial toxicity . | Baseline, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Adolescents, Young Adults, Financial Needs, Social Needs, Minority health, Caregivers