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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Nature-near integrative day care unit programme
* Behavioral: Conventional integrative day care unit programme


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - cancer diagnosis Exclusion Criteria: cognitive impairment that would interfere with questionnaire replies or the intervention pregnancy or lactation known serious mental illness participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Outdoor<br>Nature-centered therapy in a near-natural area | Behavioral: Nature-near integrative day care unit programme<br>* Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme<br>|
| Active Comparator: Indoor<br>Conventional therapy in rooms mainly in a hospital building | Behavioral: Conventional integrative day care unit programme<br>* Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - General (FACT-G) | Assessing full scale, range 0-108, higher score meaning a better outcome | Change from date of inclusion (baseline) at 12 weeks and at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | Assessing full scale, range 0-40, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Functional Assessment of Cancer Therapy: Fatigue (FACT-F) | Assessing full scale, range 0-52, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| WHO-Five Well-Being Index (WHO-5) | Assessing full scale, range 0-25, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Perceived Benefits of Nature Questionnaire (PBNQ) | mean score of the 11 items, range 1-7, lower score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Perceived Stress Scale (PSS-10) | Assessing full scale, range 0-40, lower score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Hospital Anxiety and Depression Scale (HADS) | Assessing full scale, range 0-42, lower score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Flourishing Scale (FS-D) | Assessing full scale, range 8-56, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Freiburg Mindfulness Inventory (FMI) | Assessing full scale, range 0-56, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Insomnia Severity Index (ISI) | Assessing full scale, range 0-28, lower score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Self-Efficacy Scale - Short Form (ASKU) | mean score of the 3 items, range 1-5 | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Self-Compassion Scale (SCS-D) | mean score of 12 items, range 1-5, higher score meaning a better outcome | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Behavioral questions: alcohol consumption | Number of alcoholic beverages on average per week in the last month | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Behavioral questions: relaxation | Relaxation behavior on average per week in the last month in minutes | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Behavioral questions: cigarettes | Number of cigarettes on average per week in the last month in minutes | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Sociodemographic Measurements | Age, gender, education level, household income, employment status, marital status, complete family history, current and previous diseases and co-morbidities, current medication intake | Date of inclusion (baseline) | 
| Body weight | kg | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 
| Expectation questions | For intervention 1 and intervention 2 on a 5-point likert scale from 1 (nothing at all) to 5 (very strong) | Date of inclusion (baseline) | 
| Behavioral questions: sport | Sports behavior on average per week in the last month in minutes | Date of inclusion (baseline), after 12 weeks, after 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nature, Mind-Body Therapies, Mindfulness, Yoga, Meditation