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

Cancer Clinical Trial

— TK-Onko  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411251
• Other study ID #: TK-Onko
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cancer
• Neoplasms

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