Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
2018年1月9日 更新者：Fred Hutchinson Cancer Center
Prospective Assessment of Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
We are interested in studying whether and how medical problems other than primary cancer before hematopoietic cell transplantation would impact the profiles of quality of life and toxicities post-transplantation for patients with blood cancers.
We want to see if by assessing comorbidities (such as diabetes) early on, we can identify those patients who will have more toxicities or limitations in their quality of life after transplant.
The generated information could set the stage for future intervention studies aiming to improve quality of life for patients with blood cancers after transplantation.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
252
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
-
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Washington
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Seattle、Washington、美国、98109
- Fred Hutchinson Cancer Research Center
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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
19年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients diagnosed with hematological malignancies who are being treated with allogeneic hematopoietic cell transplantation (HCT) at the Seattle Cancer Care Alliance.
描述
Inclusion Criteria:
- Allogeneic HCT candidates who are >18 years of age
- Able to speak and read English
- Able to provide informed consent
- Access to a telephone for study-related communications
- Diagnosed with a hematological malignant disease
- Willing to complete survey packets at 5 time-points, spanning two years
Exclusion Criteria:
- HCT candidates who are 18 years or younger at the time of study enrollment
- HCT candidates who cannot read, write, or speak English
- Patients with diagnoses of non-malignant diseases, or solid tumors are primary disease
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
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The MD Anderson Symptom Inventory
大体时间：Change from Baseline in Symptoms at 3,6,12,and 24 months
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A 19-item instrument, it assesses physical symptoms and their interference with life.
|
Change from Baseline in Symptoms at 3,6,12,and 24 months
|
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The Functional Assessment of Cancer Therapy Bone Marrow Transplant Scale
大体时间：Change from Baseline in Symptoms at 3,6,12,and 24 months
|
A 49-item questionnaire measuring quality of life in bone marrow transplant patients, it measures physical, functional, social/family and emotional well-being in addition to bone marrow transplant-specific concerns.
|
Change from Baseline in Symptoms at 3,6,12,and 24 months
|
|
The EQ-5D
大体时间：Change from Baseline in Symptoms at 3,6,12,and 24 months
|
This measure is used to measure utilities that can be used to calculate a quality adjusted survival score.
|
Change from Baseline in Symptoms at 3,6,12,and 24 months
|
|
The Social Activity Log
大体时间：Change from Baseline in Symptoms at 3,6,12,and 24 months
|
This measure captures the frequency and diversity of social activities outside of daily responsibilities.
|
Change from Baseline in Symptoms at 3,6,12,and 24 months
|
|
ENRICHD Social Support Instrument
大体时间：Change from Baseline in Symptoms at 3,6,12,and 24 months
|
This measures social support, including participation in social activities and perception of social support.
|
Change from Baseline in Symptoms at 3,6,12,and 24 months
|
|
The Cancer and Treatment Distress Scale
大体时间：Change from Baseline in Symptoms at 3,6,12,and 24 months
|
This is a 25-item scale assessing distress related to perceived demands from events specific to cancer survivors.
|
Change from Baseline in Symptoms at 3,6,12,and 24 months
|
|
The Patient Health Questionnaire-9
大体时间：Change from Baseline in Symptoms at 3,6,12,and 24 months
|
The PHQ-9 measures measures depression and parallels the nine diagnostic symptom criteria of the DSM-IV for Major Depressive Disorder.
|
Change from Baseline in Symptoms at 3,6,12,and 24 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE)
大体时间：at 90 days
|
We will measure toxicities using the NCI CTCAE
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at 90 days
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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
- 首席研究员：Mohamed L Sorror, MD; MSc、Fred Hutchinson Cancer Center
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
2012年10月1日
初级完成 (实际的)
2016年6月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2013年8月15日
首先提交符合 QC 标准的
2013年8月26日
首次发布 (估计)
2013年8月29日
研究记录更新
最后更新发布 (实际的)
2018年1月11日
上次提交的符合 QC 标准的更新
2018年1月9日
最后验证
2018年1月1日
更多信息
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.