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临床试验/NCT06746948
NCT06746948已完成不适用

Prevalence and Influencing Factors of the Dyadic Psychological Stress Among Patients With Lung Cancer and Their Family Caregivers: A Cross-Sectional Study

未提供1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2021年1月1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
254
试验地点
1
主要终点
depression

研究概览

简要总结

A lung cancer diagnosis has a huge impact on the psychological well-being of both patients and family caregivers. However, the current psychological stress status among dyads remains unclear. The investigators aimed to determine the prevalence of anxiety and depression and identify the factors that influence patients with lung cancer and their caregivers. The investigators will conduct a cross-sectional study of 254 dyads of lung cancer patients and family caregivers from four tertiary hospitals in Hunan Province, China from January 2021 to June 2021. Besides, the investigators used several instruments to collect data on depression, anxiety, illness perception, mindfulness, self-compassion, and dyadic coping. The independent samples t-test, analysis of one-way variance, Spearman's correlation analysis, and multiple linear regression analysis were employed. The results will recommend oncology nurses promptly screen high-risk patient-caregiver dyads who may suffer from severe psychological stress and provide them with targeted psychosocial interventions.

研究设计

研究类型
Observational
观察模型
Family Based
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

  • As for patients: aged≥18 years; hospitalized patients with lung cancer diagnosed by pathological section or cytology; and relatively stable condition, conscious, and able to express their willingness correctly.
  • As for caregivers: aged ≥18 years; a primary caregiver with a cumulative caregiving time of more than 33 hours; and a family member of the patient with lung cancer, such as spouse, children, parents, or other relatives.

排除标准

  • As for patients: people with a combination of other cancers or serious life-threatening diseases; the presence of audiological disorders or previous mental or cognitive disorders, such as anxiety disorder, or depression disorder; and receiving mental disorder treatments.
  • As for caregivers: formal caregivers with employment relationships, such as nannies; the presence of audiological disorders or previous mental disorders or cognitive disorders, such as anxiety disorder, depression disorder; and receiving mental disorder treatments.

结局指标

主要结局

depression

时间窗: From enrollment through study completion, an average of 6 months

The investigators measured dyadic depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9), which is a 9-item questionnaire. Scores range from 0 to 27, with higher scores indicating more severe depression. According to Kroenke et al.'s scoring of the PHQ-9, a score of 0-4 indicates no depression, 5-9 indicates mild depression, 10-14 indicates moderate depression, 15-19 indicates moderate severe depression, and 20-27 indicates severe depression. The prevalence of depression is equal to the number of cases with a PHQ-9 score of 5 or greater divided by the total number of cases. Cronbach's alpha coefficients in this study were 0.85 and the KMO test value was 0.719, which showed good reliability and validity.

anxiety

时间窗: From enrollment through study completion, an average of 6 months

The investigators assessed anxious symptoms using the Generalized Anxiety Disorder-7 scale (GAD-7), which is a 7-item questionnaire. Scores range from 0 to 21, with higher scores indicating more severe anxiety. According to Spitzer et al's evaluation of GAD-7 scale, a score of 0-4 indicates no anxiety, 5-9 indicates mild anxiety, 10-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. The prevalence of anxiety was defined as the number of cases with a GAD-7 score of 5 or greater divided by the total number of cases. Cronbach's alpha coefficients in this study were 0.93, respectively and KMO test value was 0.927, which showed good reliability and validity.

次要结局

  • Illness Perception(From enrollment through study completion, an average of 6 months)
  • mindfulness(From enrollment through study completion, an average of 6 months)
  • self-compassion(From enrollment through study completion, an average of 6 months)
  • dyadic coping(From enrollment through study completion, an average of 6 months)

研究者

发起方
未提供

研究点 (1)

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