Characterizing and Addressing Financial Toxicity in AYAs with Cancer

Trial Title: Characterizing and Addressing Financial Toxicity in AYAs with Cancer

NCT ID: NCT06072833

Condition: Cancer in Adolescence

Conditions: Official terms:
Financial Stress

Conditions: Keywords:
Cancer
Adolescents
Young Adults
Financial Needs
Social Needs
Minority health
Caregivers

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Participants who screen positive all move forward to receive the intervention.

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Patient Financial Education / Navigation
Description: 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.
Arm group label: Patient Financial Education / Navigation

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.

Criteria for 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)

Gender: All

Minimum age: 15 Years

Maximum age: 39 Years

Healthy volunteers: No

Locations:

Facility:
Name: Columbia University Irving Medical Center

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: M B

Start date: November 15, 2023

Completion date: June 2025

Lead sponsor:
Agency: Columbia University
Agency class: Other

Collaborator:
Agency: Patient Advocate Foundation
Agency class: Other

Source: Columbia University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06072833