NCT04411251已完成不适用
Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
Outdoor
Experimental
Nature-centered therapy in a near-natural area
干预措施: Nature-near integrative day care unit programme (Behavioral)
Indoor
Active Comparator
Conventional therapy in rooms mainly in a hospital building
干预措施: Conventional integrative day care unit programme (Behavioral)
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
- Sociodemographic Measurements(Date of inclusion (baseline))
- 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)
- Hospital Anxiety and Depression Scale (HADS)(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)
- 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)
- Expectation questions(Date of inclusion (baseline))
- Functional Assessment of Cancer Therapy: Fatigue (FACT-F)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
- Flourishing Scale (FS-D)(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
Andreas Michalsen
Prof. Dr. med.
Charite University, Berlin, Germany
研究点 (1)
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