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").
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
107
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, Germany
Functional Assessment of Cancer Therapy - General (FACT-G)
Assessing full scale, range 0-108, higher score meaning a better outcome
Time frame: Change from date of inclusion (baseline) at 12 weeks and at 24 weeks
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Assessing full scale, range 0-40, higher score meaning a better outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
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Flourishing Scale (FS-D)
Assessing full scale, range 8-56, higher score meaning a better outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Date of inclusion (baseline)
Body weight
kg
Time frame: 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)
Time frame: Date of inclusion (baseline)
Behavioral questions: sport
Sports behavior on average per week in the last month in minutes
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks