Cancer in Adolescence
Conditions
Keywords
Cancer, Adolescents, Young Adults, Financial Needs, Social Needs, Minority health, Caregivers
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.
Interventions
BEHAVIORALPatient 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.
Sponsors
Columbia University
Patient Advocate Foundation
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Participants who screen positive all move forward to receive the intervention.
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Completed the Intervention | 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. |
| Number of Eligible Participants Who Received the Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comprehensive Score of Financial Toxicity (COST Measure) Score | 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 . |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMelissa Beauchemin
Columbia University
Participant flow
Pre-assignment details
Only patients were considered to be enrolled in this study. The enrollment number and number of participants completed represents only patients.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
None listed