Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
TK-Onko
Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
1 other identifier
interventional
107
1 country
1
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").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable cancer
Started Jul 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
July 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedJune 2, 2023
June 1, 2023
1.8 years
May 25, 2020
June 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (18)
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Functional Assessment of Cancer Therapy: Fatigue (FACT-F)
Date of inclusion (baseline), after 12 weeks, after 24 weeks
WHO-Five Well-Being Index (WHO-5)
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Perceived Benefits of Nature Questionnaire (PBNQ)
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Perceived Stress Scale (PSS-10)
Date of inclusion (baseline), after 12 weeks, after 24 weeks
- +13 more secondary outcomes
Other Outcomes (1)
Qualitative interviews
12 weeks and 24 weeks after inclusion
Study Arms (2)
Outdoor
EXPERIMENTALNature-centered therapy in a near-natural area
Indoor
ACTIVE COMPARATORConventional therapy in rooms mainly in a hospital building
Interventions
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
Eligibility Criteria
You may qualify if:
- \- cancer diagnosis
You may not qualify if:
- cognitive impairment that would interfere with questionnaire replies or the intervention
- pregnancy or lactation
- known serious mental illness
- participation in another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109, Germany
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med.
Study Record Dates
First Submitted
May 25, 2020
First Posted
June 2, 2020
Study Start
July 14, 2020
Primary Completion
May 1, 2022
Study Completion
May 1, 2022
Last Updated
June 2, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share