Clinical trial NCT06072833: Characterizing and Addressing Financial Toxicity in AYAs With Cancer
Official title: Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer in Adolescence
Keywords: Cancer
Adolescents
Young Adults
Financial Needs
Social Needs
Minority health
Caregivers
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Patient Advocate Foundation
First posted: 2023-10-10
Enrollment: 46
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants who screen positive all move forward to receive the intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Number of (OR percentage of) participants who completed the intervention
timeFrame: Up to 6 months
measure: Percentage of eligible participants who consented to be in study
timeFrame: Up to 6 months
Secondary outcomes:
measure: Comprehensive Score of Financial Toxicity (COST measure)
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Melissa Beauchemin
role: PRINCIPAL_INVESTIGATOR
References:
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citation: de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.
citation: Danhauer SC, Canzona M, Tucker-Seeley RD, Reeve BB, Nightingale CL, Howard DS, Puccinelli-Ortega N, Little-Greene D, Salsman JM. Stakeholder-informed conceptual framework for financial burden among adolescents and young adults with cancer. Psychooncology. 2022 Apr;31(4):597-605. doi: 10.1002/pon.5843. Epub 2021 Nov 5.
citation: Beauchemin MP, Elkin EB, Wright JD, Kukafka R, Hershman DL, Kahn J. Incorporating systematic financial screening into the electronic health record. Journal of Clinical Oncology. 2021;39(28_suppl):184-184.