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临床试验/NCT03372356
NCT03372356Unknown不适用

Psychosocial Screening for Neuroendocrine Tumor Patients

Peking University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年8月9日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
DT

研究概览

简要总结

This is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. The application involves monitoring using the NCCN Distress Thermometer(DT), Hospital Anxiety and Depression Scale(HADS), Self-Perceived Burden Scale(SPBS) and Connor-Davidson Resilience Scale(CD-RISC). These assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. Patients will have the option of filling out questionnaires more frequently if desired.

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

  • sign written informed consent form;
  • age ≥ 18 years;
  • pathologically confirmed well-differentiated neuroendocrine tumors, G1-2 (Ki67≤20%);

排除标准

  • <18 years;
  • Neuroendocrine carcinoma;
  • History of psychiatric or psychologic illness;
  • History of previous cancers or cancer distress;
  • Patients with central nervous system(CNS) disorder;
  • Severe, uncontrolled medical condition that would affect patients' compliance;

结局指标

主要结局

DT

时间窗: every 3 month until 24 month

Distress Thermometer

次要结局

  • HADS(every 3 month until 24 month)
  • SPBS(every 3 month until 24 month)
  • CD-RISC(every 3 month until 24 month)

研究者

发起方
Peking University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shen Lin

MD, Professor, Chief of Department of GI Oncology, Peking University Cancer Hospital

Peking University

研究点 (1)

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