跳至主要内容
临床试验/NCT06033716
NCT06033716已完成不适用

Exploring the Developmental Changes and Relationship Between Resilience and Anxiety and Depression in Elderly Gastric Cancer Survivors: Based on Latent Growth Modeling and Cross-lagged Modeling

Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 412 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
412
试验地点
1
主要终点
resilience

研究概览

简要总结

This study will explore the dynamic interaction between mental resilience, anxiety and depression in elderly patients with gastric cancer 1 year after surgery, in order to better understand the role of these two factors in patients' mental health, and provide accurate insights for clinical practice and targeted psychological support strategies.

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
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with gastric cancer by endoscopy or pathology
  • age ≥60 years old
  • radical gastrectomy was proposed
  • be able to communicate simply in writing and verbal

排除标准

  • received preoperative radiotherapy or chemotherapy;
  • combined with other sites of malignant tumors;
  • combined with severe heart, liver, lung and renal insufficiency;
  • recent using hormones, immunosuppressants;
  • with physical disabilities.

结局指标

主要结局

resilience

时间窗: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)

The Chinese version of 10-item Connor-Davidson Resilience Scale (CD-RISC-10), translated and revised by Chinese scholars, was used in this study. Cronbach's alpha for the Chinese version was 0.855, indicating good internal consistency. It was also applied to cancer patients in China. Each of which was scored on a 5-point Likert scale, ranging from 1 to 5 points, from "Never" to "Almost always", with higher scores representing a higher level of psychological resilience.

anxiety

时间窗: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)

Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.

depression

时间窗: immediately after surgery (T1), three month post-surgery (T2), six months post-surgery (T3), 12 months post-surgery (T4)

Chinese version of the Hospital Anxiety and Depression Scale (HADS) was used in this study to assess the anxiety and depression of elderly cancer patients, which was developed by Zigmond AS et al. The scale consists of 14 items, including anxiety and depression subscales. Each item is rated on a 4 point scale, and the scores of the anxiety and depression scales range from 0 to 21 points. The Cronbach's α coefficient of the HADS for this study was 0.85.

次要结局

未报告次要终点

研究者

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

Yinning Guo

Principal Investigator

Nanjing Medical University

研究点 (1)

Loading locations...

相似试验