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临床试验/NCT02312830
NCT02312830Enrolling By Invitation不适用

Belgian Cross-sectional Allogeneic Transplant Survivor Study

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 400 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
400
主要终点
composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation

研究概览

简要总结

With the increasing successful use of allogeneic hematopoietic stem cell transplantation (HSCT) to cure advanced hematological disease, it becomes essential to evaluate the long-term effects of such a drastic treatment.

This study investigates the prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation. Income, return to work, social isolation, pain, medication adherence, influenza vaccination status, alcohol use, smoking habits, drug use, healthy diet, prevention of UV exposure, physical activity, functional status/Quality of life (QoL), couple life/sexual function, depression, anxiety, spirituality and resilience will be studied.

详细描述

This is a cross sectional study, where participants are interviewed and fill in a self reported survey. The interview and survey are only taken once. It is non interventional because the patients only give us extra information, which is not usually recorded in our medical records.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability to read and write in Dutch
  • Age above 18 years at time of transplant
  • Transplanted in UZ Leuven between 1992 and 2012 with an allogeneic donor (i.e. being at least 2 years post-Tx)
  • Presenting for a periodic health check in UZLEUVEN from November 15th, 2014 to November 15th 2016
  • Willing to provide oral and written consent

排除标准

  • Unable to communicate fluently in Dutch
  • Presenting with major visual, hearing, cognitive or psychiatric conditions precluding participation
  • Presenting with relapse or other major illness, with less than 6 months expected survival
  • Hospitalized for a life-threatening condition

结局指标

主要结局

composite outcome: prevalence of several demographic, psychosocial and behavioral aspects of survivorship after an allogeneic transplantation

时间窗: The interview/survey will happen once per patient and will be offered to all transplant survivors (minimum 2 years post transplant) coming to the clinic between Nov 2014-Nov 2016. No follow up included.

This is a cross sectional study, assessing several aspects of survivorship with multiple validated questionnaires (EQ5D, PHQ9, GAD, SFQ, etc). These questionnaires are only taken once in all survivors approached for the study.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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