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临床试验/NCT01084694
NCT01084694已完成不适用

The Impact of Hematopoeitic Stem Cell Transplantation on Primary Caregiver Level of Burden and Distress

Northside Hospital, Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年4月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Brief Symptom Inventory and Burden Interview

研究概览

简要总结

The purpose of this study is to examine the impact that serving as a caregiver for a patient undergoing hematopoietic stem cell transplant has on the caregiver. This will include looking at the caregiver's level of burden, depression, anxiety, somatic symptoms, fatigue and overall distress. It will also look at whether caregiver burden leads to an increase in hospitalization and overall outcome.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Any patient undergoing autologous or allogeneic HSCT at The Blood and Marrow Transplant Program at Northside Hospital
  • Patients must have a single primary caregiver
  • Patients must be willing to comply with all assessments as outlined in the protocol
  • Patients must be willing to sign informed consent
  • Must be the primary caregiver for an autologous or allogenic HSCT patient at the Blood and Marrow Transplant Program at Northside Hospital
  • Caregiver must be willing to comply will all assessments as outlined in the protocol
  • Caregiver must be willing to sign consent

排除标准

  • 未提供

结局指标

主要结局

Brief Symptom Inventory and Burden Interview

时间窗: Baseline, Day 30 & 1 year

Brief Symptom Inventory (BSI) measures overall distress. Scores can range from 0-72 with the higher score representing a higher level of distress. Each question is 0-4 with 4 being higher levels of distress. Clinically significant level of distress is 25+. Burden Interview is scored on a continuum. No clinically range, but higher scores mean higher feelings of burden. Scores range from 0-88. Time frame: BSI scores and Burden scores were compared in caregivers of HSCT patients at preBMT and post BMT (30 days and 1 year).

次要结局

  • Common Characteristics of Caregivers(Baseline)
  • Length of Patient Hospitalization(pretransplant to 1 year post-transplant)
  • Overall Patient Survival(Pre-transplant to 1 year post-transplant)
  • Patient Distress, Fatigue & Pain Scores(Baseline, Day 30 & 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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