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临床试验/NCT01148927
NCT01148927已完成不适用

A Pilot Study to Evaluate the Quality of Life of Long Term Survivors of Adult Acute Lymphoblastic Leukemia

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01)

研究概览

简要总结

Acute lymphoblastic leukemia (ALL) accounts for about 20% of adult leukemias. Treatment results in adult ALL have lagged behind the improvements achieved in the pediatric population. A modified version of the Dana Farber Cancer Institute pediatric protocol is used to treat adult patients with ALL. The results seem to be superior to those reported with other adult protocols. However, there is limited data on the impact of such intensified approaches and resulting toxicities on the quality of life (QOL) of these survivors. Identifying important factors affecting the QOL may permit attempts at early interventions and may help to further modify the regimen and mitigate these adverse effects on QOL.

This study is evaluating the quality of life of long term survivors of adult ALL. It involves the patients filling out several questionnaires that are well-validated measures assessing various QOL issues of concern to these patients. The following questionnaires are used in this study:

  • EORTC QLQ C30 to assess global health and major health domains
  • Brief Pain Inventory (BPI)
  • Personal Health Questionnaire (PHQ9) to assess psychosocial distress
  • Functional Assessment of Cancer Therapy (FACT) Fatigue Questionnaire
  • Peripheral Neuropathy Questionnaire

The data obtained from the questionnaires will be analyzed and the various domains of health will be quantified.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • previously diagnosed with adult ALL or T-lymphoblastic lymphoma
  • Age >/= 18
  • Have completed the two-year modified DFCI protocol at least three months earlier and are in continuous complete remission
  • Understand English and are able to fill out questionnaires

排除标准

  • 未提供

结局指标

主要结局

To evaluate the quality of life of the long-term survivors of adult acute lymphoblastic leukemia treated uniformly with the modified Dana Farber Cancer Institute ALL protocol (91-01)

时间窗: 9 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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