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临床试验/NCT04411251
NCT04411251已完成不适用

Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2020年7月14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
107
试验地点
2
主要终点
Functional Assessment of Cancer Therapy - General (FACT-G)

研究概览

简要总结

The aim of this study is to investigate the effects of a nature-centred integrative oncology day care unit programme ("outdoor concept") compared with an already established integrative oncology day care unit programme ("indoor concept").

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • cancer diagnosis

排除标准

  • cognitive impairment that would interfere with questionnaire replies or the intervention
  • pregnancy or lactation
  • known serious mental illness
  • participation in another study

结局指标

主要结局

Functional Assessment of Cancer Therapy - General (FACT-G)

时间窗: Change from date of inclusion (baseline) at 12 weeks and at 24 weeks

Assessing full scale, range 0-108, higher score meaning a better outcome

次要结局

  • Behavioral questions: alcohol consumption(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Behavioral questions: cigarettes(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Perceived Benefits of Nature Questionnaire (PBNQ)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Perceived Stress Scale (PSS-10)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Sociodemographic Measurements(Date of inclusion (baseline))
  • Expectation questions(Date of inclusion (baseline))
  • Functional Assessment of Cancer Therapy: Fatigue (FACT-F)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Body weight(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • WHO-Five Well-Being Index (WHO-5)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Flourishing Scale (FS-D)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Self-Efficacy Scale - Short Form (ASKU)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Self-Compassion Scale (SCS-D)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Behavioral questions: sport(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Freiburg Mindfulness Inventory (FMI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Insomnia Severity Index (ISI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
  • Behavioral questions: relaxation(Date of inclusion (baseline), after 12 weeks, after 24 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Andreas Michalsen

Prof. Dr. med.

Charite University, Berlin, Germany

研究点 (2)

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