Characterizing and Addressing Financial Toxicity in AYAs With Cancer

January 9, 2024 updated by: Melissa Beauchemin, Columbia University

Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • M B

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient Financial Education / Navigation
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of (OR percentage of) participants who completed the intervention
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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)
Time Frame: Baseline, 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Patient Advocate Foundation

Investigators

  • Principal Investigator: Melissa Beauchemin, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

October 3, 2023

First Submitted That Met QC Criteria

October 3, 2023

First Posted (Actual)

October 10, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU2405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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