An interventional study of Patient Financial Education / Navigation in Cancer in Adolescence, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 15 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Columbia University · Not applicable, Interventional, and Health services research
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 26 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
AYA patient participants:
Caregiver/financial partner participants:
Exclusion Criteria:
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.
Number 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.
Time frame: Up to 6 months
Number of Eligible Participants Who Received the Intervention
This is to measure interest and the need for help by community partners that can provide patient financial education and navigation.
Time frame: Up to 6 months
Comprehensive Score of Financial Toxicity (COST Measure) Score
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 .
Time frame: Baseline, 6 months
| Milestone | Participants Eligible (Screed Positive) |
|---|---|
| Started | 26 |
| Completed | 17 |
| Not completed | 9 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Lost to follow-up | 8 |
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.
| Participants | Participants Eligible (Screened Positive) |
|---|---|
| Number of Participants Who Completed the Intervention | 21 |
This is to measure interest and the need for help by community partners that can provide patient financial education and navigation.
| Participants | Patients Eligible (Screened Positive) |
|---|---|
| Number of Eligible Participants Who Received the Intervention | 23 |
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 .
| score on a scale | Participants Eligible (Screed Positive) |
|---|---|
| Baseline | 10.47 ± 4.78 |
| 6 months | 16.53 ± 8.58 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants Eligible (Screed Positive) | 0/26 (0%) | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Participants Eligible (Screened Positive) |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 25 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Participants Eligible (Screened Positive) |
|---|---|
| Female | 20 |
| Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Participants Eligible (Screened Positive) |
|---|---|
| Hispanic or Latino | 13 |
| Not Hispanic or Latino | 9 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Participants Eligible (Screened Positive) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 9 |
| White | 4 |
| More than one race | 1 |
| Unknown or Not Reported | 10 |
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