Prospective Assessment of Associations Between Pre-transplant Comorbidities and Post-transplant Toxicities and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- The EQ-5D
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The EQ-5D
时间窗: 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.
The Cancer and Treatment Distress Scale
时间窗: 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.
The MD Anderson Symptom Inventory
时间窗: Change from Baseline in Symptoms at 3,6,12,and 24 months
A 19-item instrument, it assesses physical symptoms and their interference with life.
The Social Activity Log
时间窗: 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.
ENRICHD Social Support Instrument
时间窗: 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.
The Patient Health Questionnaire-9
时间窗: 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.
The Functional Assessment of Cancer Therapy Bone Marrow Transplant Scale
时间窗: 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.
次要结局
- National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE)(at 90 days)