Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses (TK-Onko)

June 1, 2023 updated by: Andreas Michalsen, Charite University, Berlin, Germany

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 14109
        • Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Outdoor
Nature-centered therapy in a near-natural area
Behavioral: Nature-near integrative day care unit programme
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
Active Comparator: Indoor
Conventional therapy in rooms mainly in a hospital building
Behavioral: Conventional integrative day care unit programme
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - General (FACT-G)
Time Frame: 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
Change from date of inclusion (baseline) at 12 weeks and at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 0-40, higher score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Functional Assessment of Cancer Therapy: Fatigue (FACT-F)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 0-52, higher score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
WHO-Five Well-Being Index (WHO-5)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 0-25, higher score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Perceived Benefits of Nature Questionnaire (PBNQ)
Time Frame: 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
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Perceived Stress Scale (PSS-10)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 0-40, lower score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 0-42, lower score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Insomnia Severity Index (ISI)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 0-28, lower score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Self-Compassion Scale (SCS-D)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
mean score of 12 items, range 1-5, higher score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: alcohol consumption
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Number of alcoholic beverages on average per week in the last month
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: relaxation
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Relaxation behavior on average per week in the last month in minutes
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: cigarettes
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Number of cigarettes on average per week in the last month in minutes
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Sociodemographic Measurements
Time Frame: 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
Date of inclusion (baseline)
Body weight
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
kg
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Expectation questions
Time Frame: 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)
Date of inclusion (baseline)
Behavioral questions: sport
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Sports behavior on average per week in the last month in minutes
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Flourishing Scale (FS-D)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 8-56, higher score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Freiburg Mindfulness Inventory (FMI)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Assessing full scale, range 0-56, higher score meaning a better outcome
Date of inclusion (baseline), after 12 weeks, after 24 weeks
Self-Efficacy Scale - Short Form (ASKU)
Time Frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
mean score of the 3 items, range 1-5
Date of inclusion (baseline), after 12 weeks, after 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative interviews
Time Frame: 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.
12 weeks and 24 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2020

Primary Completion (Actual)

May 1, 2022

Study Completion (Actual)

May 1, 2022

Study Registration Dates

First Submitted

May 25, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

June 2, 2020

Study Record Updates

Last Update Posted (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

June 1, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TK-Onko

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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