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临床试验/NCT06277479
NCT06277479已完成不适用

Late Effects and Health-Related Quality of Life in Survivors of Allogeneic Hematopoietic - a Cross-sectional Study

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 1,262 人开始时间: 2024年5月25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
1,262
试验地点
1
主要终点
EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100)

研究概览

简要总结

The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.

详细描述

Objective

The cross-sectional study aims to describe the burden of late effects and survivorship-specific health-related quality of life in a nationwide cohort of patients treated with allo-HSCT in Denmark. Further, identify demographic, medical or personal factors associated with better self-reported health and quality of life.

Method

An observational, descriptive, cross-sectional study using clinical data and self-reported questionnaires to assess the occurrence of comorbidities and self-reported late effects in survivors treated with allo-HSCT in Denmark between 1970 and 2024.

Study population

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All survivors treated for malignant or non-malignant hematological disease with allogeneic hematopoietic stem cell transplantation at the age of 18-79 years from 1970-2024 in Denmark are eligible

排除标准

  • Patient unable to read and understand danish are excluded from study participation

结局指标

主要结局

EORTC Quality of Life Survivorship Core questionnaire (EORTC-QOL-SURV100)

时间窗: may 2024 - August 2024

The QLQ-SURV100 is based on the EORTC Quality of Life core questionnaire (QLQ-C30). Applicable to disease-free cancer survivors. It consists of 100 questions divided over thirteen functional scales (i.e. Physical; Role ; Emotional; and Cognitive functioning; Body image; Symptom awareness; Positive health behavior change; Positive life outlook; Positive impact on behavior towards others; Positive social functioning; Work; Sexual functioning; Global health status), nine symptom scales (i.e. Social isolation; Fatigue; Pain; Sleep problems; Health distress; Negative health outlook; Social interference; Sexual problems), one Symptom checklist assessing chronic side effects of cancer treatments, and twelve single items. Score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QL represents a high QL, but a high score for a symptom item represents a high level of symptomatology.

次要结局

  • Modified 7-day Lee Chronic-versus-Host Disease Symptom Scale(may 2024 - august 2024)
  • Health literacy Questionnaire (HLQ)(may 2024 - august 2024)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mette Schaufuss Engedal

Clinical nurse specialist, Ph.d student

Rigshospitalet, Denmark

研究点 (1)

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