跳至主要内容
临床试验/NCT04592250
NCT04592250
进行中(未招募)
不适用

Financial Toxicity in Diverse Cancer Populations and Care Settings

M.D. Anderson Cancer Center10 个研究点 分布在 1 个国家目标入组 625 人2020年9月12日

概览

阶段
不适用
干预措施
Survey Administration
疾病 / 适应症
Hematopoietic and Lymphoid Cell Neoplasm
发起方
M.D. Anderson Cancer Center
入组人数
625
试验地点
10
主要终点
Financial toxicity score
状态
进行中(未招募)
最后更新
16天前

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: 1. Examine the associations between measures of self-efficacy, quality of social support, and financial literacy with the outcome measure of financial toxicity. 2. Identify the feasibility of collecting these measures in a Spanish-speaking cancer patient population. 3. Describe the relationship between financial toxicity and clinical outcomes (survival and disease status). This is an exploratory aim. 4. 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.

注册库
clinicaltrials.gov
开始日期
2020年9月12日
结束日期
2028年9月1日
最后更新
16天前
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

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

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.

研究点 (10)

Loading locations...

相似试验