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Completed

NCT Number: NCT04411251

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").

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Key information

Conditions

Cancer Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus

Berlin, 14109, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nature-near integrative day care unit programme

Behavioral

Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme

Conventional integrative day care unit programme

Behavioral

Interventions based on the Mind Body Medicine in Integrative and Complementary Medicine (MICOM) programme

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Body weight

    Time frame: Date of inclusion (baseline), after 12 weeks, after 24 weeks

    kg

  17. 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)

  18. 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

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: TK-Onko

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2020
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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