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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").
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outdoor | Experimental | Nature-centered therapy in a near-natural area |
|
| Indoor | Active Comparator | Conventional therapy in rooms mainly in a hospital building |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nature-near integrative day care unit programme | Behavioral | Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative interviews | Qualitative assessment will be carried out in qualitative interviews in 20 patients participating in the study. The interviews will be recorded, transcribed and analyzed with qualitative content analysis. | 12 weeks and 24 weeks after inclusion |
Inclusion Criteria:
- cancer diagnosis
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus | Berlin | 14109 | Germany |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Conventional integrative day care unit programme | Behavioral | Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme |
|
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 |