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临床试验/NCT06072833
NCT06072833
已完成
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Characterizing and Addressing Financial Toxicity in Adolescents and Young Adults With Cancer

Columbia University1 个研究点 分布在 1 个国家目标入组 26 人2023年11月15日

概览

阶段
不适用
干预措施
Patient Financial Education / Navigation
疾病 / 适应症
Cancer in Adolescence
发起方
Columbia University
入组人数
26
试验地点
1
主要终点
Number of Participants Who Completed the Intervention
状态
已完成
最后更新
上个月

概览

简要总结

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.

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2023年11月15日
结束日期
2025年2月28日
最后更新
上个月
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Principal Investigator
主要研究者

Melissa Beauchemin

Assistant Professor of Nursing

Columbia University

入排标准

入选标准

  • 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

排除标准

  • Unable to complete financial survey questions or contraindicated (as outlined in Protection of Human Subjects)

研究组 & 干预措施

Patients Eligible (screened positive)

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.

干预措施: Patient Financial Education / Navigation

结局指标

主要结局

Number of Participants Who Completed the Intervention

时间窗: 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

时间窗: 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.

次要结局

  • Comprehensive Score of Financial Toxicity (COST Measure) Score(Baseline, 6 months)

研究点 (1)

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