Financial Toxicity in Diverse Cancer Populations and Care Settings
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 625
- 试验地点
- 10
- 主要终点
- Financial toxicity score
研究概览
简要总结
This study will seek to generate the early data needed to understand the relationship between constructs and measures of patients' coping resources and psychological response and measures of patients' financial toxicity. To collect this early descriptive data, the overall goal of this study is to identify social, behavioral, and knowledge factors associated with financial toxicity outcomes. Identifying these factors will ultimately help elucidate targets for behavioral, psychosocial, and/or educational and coaching interventions.
详细描述
PRIMARY OBJECTIVES:
- Examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity.
- Identify the feasibility of collecting these measures in a Spanish-speaking cancer patient population.
- Describe the relationship between financial toxicity and clinical outcomes (survival and disease status). This is an exploratory aim.
- a) Describe the correlation between measures of self-efficacy, quality of social support, financial literacy and clinical and demographic patient characteristics with outcome measure of financial toxicity, by tumor type and age subgroups. b) Describe response rate to the financial toxicity measure (>50% completed items on the survey instrument), by tumor type and age subgroups. This is an exploratory aim.
OUTLINE:
Participants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must be able to read and speak English or Spanish
- •Participant must have diagnosis of cancer within the past 365 days; all disease sites and all stages are eligible for enrollment
排除标准
- •Unable to give consent
研究组 & 干预措施
Observational (survey)
Participants will complete a survey packet that is estimated to take about 30 minutes. The survey packet will be collected at baseline and at 6 months.
干预措施: Survey Administration (Other)
结局指标
主要结局
Financial toxicity score
时间窗: At 6 months
Will be measured using the ENRICh instrument. Will conduct descriptive and univariate/multivariate analyses on this association of primary interest, including Chi-square test, t-test (or non-parametric test as appropriate). Other univariate associations between financial toxicity and other covariates obtained from survey measures, considered descriptive, will be performed. will test the primary association between the Hope State measure and financial toxicity using multivariate generalized linear mixed models, accounting for longitudinal changes in outcome scores over time, as well as adjusting for covariates and potential time interactions. The mixed effects structure will also be used, via a random intercept term, to account for site-to-site differences (e.g. clustering). Standard model selection procedures (forward, backward, or stepwise selection or shrinkage penalty) will be applied to determine the final multivariate model.
次要结局
未报告次要终点