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临床试验/NCT07679165
NCT07679165已完成不适用

Dahua Hospital, Xuhui District, Shanghai

Jie Zeng1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2023年6月10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
176
试验地点
1
主要终点
Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale

研究概览

简要总结

Symptom management nursing intervention can improve the self-management efficacy, psychological resilience, and QoL of patients with advanced lung cancer.

详细描述

Self management efficacy is an important mediating variable in the impact of Symptom management nursing intervention on patients' quality of life. Psychological resilience plays a negative moderating role in the effect of Symptom management nursing intervention. Late stage lung cancer patients with low psychological resilience can obtain more significant self management efficacy and quality of life improvement from Symptom management nursing intervention, and are the key beneficiaries of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • According to the diagnostic criteria of primary lung cancer [9], the clinical stage was stage ⅢB-Ⅳ
  • aged 18-75 years old
  • Karnofsky performance status (KPS) ≥60 and expected survival ≥3 months
  • Patients had clear consciousness and normal cognitive function, and could complete the questionnaire independently or with the assistance of the researcher
  • have basic communication skills and can cooperate to complete the whole intervention
  • Patients or their families informed and signed the consent form.

排除标准

  • primary malignant tumors in other parts
  • history of severe heart, liver, kidney and other important organ failure, severe infection or mental illness
  • Unable to cooperate with the study due to cognitive impairment, visual and hearing impairment
  • participating in other similar nursing intervention studies.

结局指标

主要结局

Change in Quality of Life as measured by the Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale

时间窗: Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention)

The Functional Assessment of Cancer Therapy-Lung (FACT-L) scale will be used to assess changes in quality of life in patients with advanced lung cancer. The scale consists of 36 items across five domains: physical health status, social and family conditions, emotional well-being, functional capability, and lung cancer-specific supplementary concerns. Each item is scored on a 0-4 Likert scale, with total scores ranging from 0 to 144. Higher scores indicate better quality of life. The scale has demonstrated good reliability and validity in Chinese populations (Cronbach's α = 0.88-0.92).

次要结局

  • Change in Self-Management Efficacy as measured by the Strategies Used by People to Promote Health (SUPPH) Scale(Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention))
  • Change in Psychological Resilience as measured by the Connor-Davidson Resilience Scale (CD-RISC)(Baseline (within 24 hours of admission) and at 8 weeks (immediately post-intervention))

研究者

发起方
Jie Zeng
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Jie Zeng

Dahua Hospital, Xuhui District, Shanghai

Dahua Hospital, Xuhui District, Shanghai

研究点 (1)

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