Cancer
Conditions
Keywords
Nature, Mind-Body Therapies, Mindfulness, Yoga, Meditation
Brief summary
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).
Interventions
BEHAVIORALNature-near integrative day care unit programme
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
BEHAVIORALConventional integrative day care unit programme
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - General (FACT-G) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-40, higher score meaning a better outcome |
| Functional Assessment of Cancer Therapy: Fatigue (FACT-F) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-52, higher score meaning a better outcome |
| WHO-Five Well-Being Index (WHO-5) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-25, higher score meaning a better outcome |
| Perceived Benefits of Nature Questionnaire (PBNQ) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | mean score of the 11 items, range 1-7, lower score meaning a better outcome |
| Perceived Stress Scale (PSS-10) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-40, lower score meaning a better outcome |
| Hospital Anxiety and Depression Scale (HADS) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-42, lower score meaning a better outcome |
| Flourishing Scale (FS-D) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 8-56, higher score meaning a better outcome |
| Freiburg Mindfulness Inventory (FMI) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-56, higher score meaning a better outcome |
| Insomnia Severity Index (ISI) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Assessing full scale, range 0-28, lower score meaning a better outcome |
| Self-Compassion Scale (SCS-D) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | mean score of 12 items, range 1-5, higher score meaning a better outcome |
| Behavioral questions: alcohol consumption | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Number of alcoholic beverages on average per week in the last month |
| Behavioral questions: relaxation | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Relaxation behavior on average per week in the last month in minutes |
| Behavioral questions: cigarettes | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Number of cigarettes on average per week in the last month in minutes |
| Sociodemographic Measurements | Date of inclusion (baseline) | Age, gender, education level, household income, employment status, marital status, complete family history, current and previous diseases and co-morbidities, current medication intake |
| Body weight | Date of inclusion (baseline), after 12 weeks, after 24 weeks | kg |
| Expectation questions | Date of inclusion (baseline) | For intervention 1 and intervention 2 on a 5-point likert scale from 1 (nothing at all) to 5 (very strong) |
| Behavioral questions: sport | Date of inclusion (baseline), after 12 weeks, after 24 weeks | Sports behavior on average per week in the last month in minutes |
| Self-Efficacy Scale - Short Form (ASKU) | Date of inclusion (baseline), after 12 weeks, after 24 weeks | mean score of the 3 items, range 1-5 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative interviews | 12 weeks and 24 weeks after inclusion | 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. |
Countries
Germany
Outcome results
None listed