CancerTK-OnkoNCT04411251
Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
A study testing Nature-near integrative day care unit programme and Conventional integrative day care unit programme in people with Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
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"). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cancer
- What is being tested?
- Nature-near integrative day care unit programme and Conventional integrative day care unit programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jul 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cancer diagnosis
Who cannot join
- cognitive impairment that would interfere with questionnaire replies or the intervention
- pregnancy or lactation
- known serious mental illness
- participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Berlin, 14109
About this study
Official title: 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").
- Conditions
- Cancer
- Being tested
- Nature-near integrative day care unit programme, Conventional integrative day care unit programme
- Keywords
- Nature, Mind-Body Therapies, Mindfulness, Yoga, Meditation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nature-near integrative day care unit programmeBehavioural
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
Conventional integrative day care unit programmeBehavioural
Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme
| Study group | Role | What they receive |
|---|---|---|
| Outdoor | Experimental | Nature-centered therapy in a near-natural area Receives: Behavioral: Nature-near integrative day care unit programme |
| Indoor | Active comparator | Conventional therapy in rooms mainly in a hospital building Receives: Behavioral: Conventional integrative day care unit programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy - General (FACT-G)
Assessing full scale, range 0-108, higher score meaning a better outcome
Measured: 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)
Assessing full scale, range 0-40, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Functional Assessment of Cancer Therapy: Fatigue (FACT-F)
Assessing full scale, range 0-52, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
WHO-Five Well-Being Index (WHO-5)
Assessing full scale, range 0-25, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Perceived Benefits of Nature Questionnaire (PBNQ)
mean score of the 11 items, range 1-7, lower score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Perceived Stress Scale (PSS-10)
Assessing full scale, range 0-40, lower score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Hospital Anxiety and Depression Scale (HADS)
Assessing full scale, range 0-42, lower score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Flourishing Scale (FS-D)
Assessing full scale, range 8-56, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Freiburg Mindfulness Inventory (FMI)
Assessing full scale, range 0-56, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Insomnia Severity Index (ISI)
Assessing full scale, range 0-28, lower score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Self-Efficacy Scale - Short Form (ASKU)
mean score of the 3 items, range 1-5
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Self-Compassion Scale (SCS-D)
mean score of 12 items, range 1-5, higher score meaning a better outcome
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: alcohol consumption
Number of alcoholic beverages on average per week in the last month
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: relaxation
Relaxation behavior on average per week in the last month in minutes
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Behavioral questions: cigarettes
Number of cigarettes on average per week in the last month in minutes
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
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
Measured: Date of inclusion (baseline)
Body weight
kg
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Expectation questions
For intervention 1 and intervention 2 on a 5-point likert scale from 1 (nothing at all) to 5 (very strong)
Measured: Date of inclusion (baseline)
Behavioral questions: sport
Sports behavior on average per week in the last month in minutes
Measured: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start14 Jul 2020
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Michalsen, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411251
- Sponsor's protocol ID
- TK-Onko
- Acronym
- TK-Onko
- Status last verified
- Jun 2023
- First submitted
- 25 May 2020
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
- ClinicalTrials.gov ID
- NCT04411251
- Acronym / sponsor ID
- TK-Onko / TK-Onko
- Conditions
- Cancer
- Keywords
- Nature, Mind-Body Therapies, Mindfulness, Yoga, Meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 14 Jul 2020 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outdoor | Experimental | Behavioral: Nature-near integrative day care unit programmeNature-centered therapy in a near-natural area |
| Indoor | Active comparator | Behavioral: Conventional integrative day care unit programmeConventional therapy in rooms mainly in a hospital building |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cancer diagnosis
Key exclusion criteria (4 listed)
- cognitive impairment that would interfere with questionnaire replies or the intervention
- pregnancy or lactation
- known serious mental illness
- participation in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nature-near integrative day care unit programmeInterventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme | Behavioural | Outdoor |
| Conventional integrative day care unit programmeInterventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme | Behavioural | Indoor |
Primary outcome
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
18 secondary outcomes
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
Time frame: 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
WHO-Five Well-Being Index (WHO-5)
Time frame: 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
Perceived Stress Scale (PSS-10)
Time frame: 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
Flourishing Scale (FS-D)
Time frame: 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
Insomnia Severity Index (ISI)
Time frame: 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
Self-Compassion Scale (SCS-D)
Time frame: 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
Behavioral questions: relaxation
Time frame: 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
Sociodemographic Measurements
Time frame: Date of inclusion (baseline)
Body weight
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Expectation questions
Time frame: Date of inclusion (baseline)
Behavioral questions: sport
Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nature-near integrative day care unit programme and Conventional integrative day care unit programme in people with Cancer, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy - General (FACT-G) (time frame: Change from date of inclusion (baseline) at 12 weeks and at 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.