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The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family

The Financial Impact of Allogeneic Stem Cell Transplantation on Patient and Family: A Pilot Study

The purpose of this pilot study is to determine the feasibility of conducting a study of out-of-pocket costs and the long-term financial impact of allogeneic stem cell transplant.

研究概览

详细说明

Allogeneic hematopoietic stem cell transplantation (HSCT) is the indicated treatment for many life-threatening illnesses affecting both adults and children. Transplant recovery and late effects require long-term medical care. At the same time that the family faces a medical crisis, a resulting financial crisis may also be pending, but is often pushed to the background due to the necessity of first preserving life. A large proportion of patients undergoing HSCT incur significant financial burden from out-of-pocket costs and a decrease in household income. Predetermined variables, both medical and demographic, gathered at the pre-transplant clinical consultation have the potential to predict the patients at greatest financial risk. This study will describe both the out-of-pocket costs and the income changes that may result from HSCT to help patients and their caregivers have a clearer picture of these costs and develop a financial plan. Health care providers can utilize this information to better inform patients and connect them to resources.

研究类型

观察性的

注册 (实际的)

30

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota
    • New York
      • Buffalo、New York、美国、14263
        • Roswell Park Cancer Institute
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Medical College of Wisconsin

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Pediatric and adult allogeneic stem cell transplant recipients and their care givers from three U.S. transplant medical centers.

描述

Inclusion Criteria:

  1. Adult recipients and parents/guardians of pediatric (age 0-17 years) recipients of allogeneic HSCT
  2. Recipient has a primary caregiver, who is a member of the recipient's household
  3. Allogeneic HSCT using any donor cell source (related, unrelated, or cord blood)
  4. Any age at HSCT
  5. Diagnosis of primary disease for which HSCT is being performed must have been made within two years prior to transplantation
  6. Adult recipients, parents/guardians of pediatric recipients, and primary caregivers should be able to read, write, and understand the English language
  7. Signed informed consent from adult patient, caregiver and/or parent/guardian for study participation
  8. Signed consent to participate in the Center for International Blood and Marrow Transplant Research (CIBMTR) research database.

Exclusion Criteria:

  1. Recipients who have had a previous HSCT (autologous or allogeneic)
  2. Households with more than one transplant recipient

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
allogeneic stem cell recipients
Pediatric and adult allogeneic stem cell transplant recipients and their care givers.
Baseline financial survey pre-transplant, financial diary post-transplant every two weeks for 3 months, and financial questionnaire via phone survey at 6, 12, 18 and 24 months post-transplant.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To study the feasibility of using a patient maintained diary to capture out-of-pocket costs over the first 3 months following allogeneic HSCT
大体时间:Pre-transplant and for 3 months post-transplant
Pre-transplant and for 3 months post-transplant

次要结果测量

结果测量
大体时间
To determine the feasibility of conducting interviews to collect financial information at 6, 12, 18 and 24 months after allogeneic HSCT
大体时间:6, 12, 18 and 24 month time points post-transplant
6, 12, 18 and 24 month time points post-transplant

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Navneet Majhail, MD, MS、University of Minnesota / CIBMTR
  • 学习椅:Douglas Rizzo, MD, MS、Medical College of Wisconsin / CIBMTR

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年3月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2015年8月1日

研究注册日期

首次提交

2008年11月19日

首先提交符合 QC 标准的

2008年11月20日

首次发布 (估计)

2008年11月21日

研究记录更新

最后更新发布 (估计)

2015年10月6日

上次提交的符合 QC 标准的更新

2015年10月5日

最后验证

2015年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • CIBMTR HS 07-02

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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