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临床试验/NCT03818230
NCT03818230已完成不适用

An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients.

University of Manchester1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年8月21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
64
试验地点
1
主要终点
Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.

研究概览

简要总结

This is an exploratory prospective observational cohort study to establish the levels of psychological distress in early phase clinical trial patients and evaluate the psychological impact of early phase clinical trials on cancer patients. Participants will be requested to complete self-reported questionnaires, measuring levels of anxiety, depression and hope, at different time points along the clinical trials pathway.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Aged 18 years and older
  • Able to provide informed consent
  • Are being considered for an early phase clinical trial

排除标准

  • Patients unable to comprehend English language

结局指标

主要结局

Levels of anxiety and depression as per the Hospital Anxiety and Depression Scale questionnaire.

时间窗: Approximately 14 weeks.

次要结局

  • Levels of hope as per the Adult Hope Scale.(Approximately 14 weeks.)

研究者

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

Dr Natalie Cook

Honorary Consultant in Medical Oncology

University of Manchester

研究点 (1)

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