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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04411251
Other study ID # TK-Onko
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 14, 2020
Est. completion date May 1, 2022

Study information

Verified date June 2023
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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").


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nature-near integrative day care unit programme
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
Conventional integrative day care unit programme
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme

Locations

Country Name City State
Germany Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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)
Secondary Body weight kg Date of inclusion (baseline), after 12 weeks, after 24 weeks
Secondary 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)
Secondary 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
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