NCT04340219已完成不适用
A Prospective Cohort Study Investigating Oncology-patient-reported Anxiety, Mood, and Quality of Life During the COVID-19 Pandemic (ONCOVID Trial)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Depression at baseline measured by the 7-item depression subscale of the 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression); in terms of proportions (0-4 vs ≥ 5).
研究概览
简要总结
ONCOVID is a prospective cohort study investigating oncology-patient-reported anxiety, mood, and quality of life during the COVID-19 pandemic. Participants complete a survey consisting of sociodemographic information and self-administered questionnaires (COVID-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, and WHO Quality of Life-BREF). Data collection occurs at baseline and follow-up surveys are performed after 6, 12, and 24 weeks.
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
- 否
入选标准
- •≥ 18 years of age
- •Histologically confirmed cancer
- •Receive systemic therapy (including chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, endocrine therapy, or investigational agent) (either exclusively or in combination with other anticancer therapy) between February 14, 2020 and March 31, 2020 (Note: Patients whose systemic treatment administration was initially planned for this period but was modified, delayed, stopped, or withheld due to COVID-19 measures are also eligible for inclusion)
排除标准
- •Insufficient understanding of the Dutch language
- •Severe cognitive impairment
- •Acute psychiatric crisis
- •Not able to give informed consent
- •Confirmed or clinically suspected COVID-19
- •Endocrine therapy in (neo)adjuvant setting (Note: Patients whose (neo)adjuvant systemic treatment was initially planned as chemotherapy, targeted small-molecule therapy, anticancer monoclonal antibody, immunotherapy, or investigational agent (either exclusively or in combination in combination with other anticancer therapy) but was modified to endocrine therapy due to COVID-19 measures are also eligible for inclusion)
结局指标
主要结局
Depression at baseline measured by the 7-item depression subscale of the 21-item Depression, Anxiety, and Stress Scale (DASS-21) (DASS-21-Depression); in terms of proportions (0-4 vs ≥ 5).
时间窗: Week 0
Stress at baseline measured by the 7-item stress subscale of the DASS-21 (DASS-21-Stress); in terms of proportions (0-7 vs ≥ 8).
时间窗: Week 0
Distress at baseline measured by the COVID-19 Peritraumatic Distress Index (CPDI); in terms of proportions (0-28 vs ≥ 29).
时间窗: Week 0
Anxiety at baseline measured by the 7-item anxiety subscale of the DASS-21 (DASS-21-Anxiety); in terms of proportions (0-3 vs ≥ 4).
时间窗: Week 0
次要结局
- Depression at baseline measured by the DASS-21-Depression; in terms of continuous values.(Week 0)
- Domain-specific quality of life at baseline measured by the 3-item social relationships domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Social relationships); in terms of continuous values.(Week 0)
- Domain-specific quality of life at baseline measured by the 6-item psychological health domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Psychological health); in terms of continuous values.(Week 0)
- Change from baseline in distress measured by CDPI; in terms of continuous values.(24 weeks)
- Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Physical health; in terms of continuous values.(24 weeks)
- Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Social relationship; in terms of continuous values.(24 weeks)
- Change from baseline in domain-specific quality of life measured by the WHOQOL-BREF-Environment; in terms of continuous values.(24 weeks)
- Distress measured at baseline by the CPDI; in terms of continuous values.(Week 0)
- Stress at baseline measured by the DASS-21-Stress; in terms of continuous values.(Week 0)
- Domain-specific quality of life at baseline measured by the 7-item physical health domain of the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire (WHOQOL-BREF-Physical health); in terms of continuous values.(Week 0)
- Change from baseline in stress measured by the DASS-21-Stress; in terms of continuous values.(24 weeks)
- Anxiety at baseline measured by the DASS-21-Anxiety; in terms of continuous values.(Week 0)
- Change from baseline in domain-specific quality of life at baseline measured by the WHOQOL-BREF-Psychological health; in terms of continuous values.(24 weeks)
- The real-life impact of COVID-19 on systemic treatment administration will be assessed using descriptive statistics(Week 0-6-12-24)
- Domain-specific quality of life at baseline measured by the 8-item environment domain of the WHOQOL-BREF questionnaire (WHOQOL-BREF-Environment); in terms of continuous values.(Week 0)
- Change from baseline in depression measured by the DASS-21-Depression; in terms of continuous values.(24 weeks)
- Overall perception of quality of life and overall perception of health at baseline measured by the two items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire-in terms of continuous values.(Week 0)
- Change from baseline in anxiety measured by the DASS-21-Anxiety; in terms of continues values.(24 weeks)
- Change from baseline in overall perception of quality of life and overall perception of health measured by the 2 items from the Overall QOL and General Health in the WHOQOL-BREF questionnaire; in terms of continuous values.(24 weeks)
研究者
研究点 (1)
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