Clinical trial NCT04411251: Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
Official title: Integrative Oncology - Evaluation of a Oncology Day Care Unit Programme With Two Different Focuses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Nature
Mind-Body Therapies
Mindfulness
Yoga
Meditation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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").


Eligibility criteria: 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

Primary outcomes:
measure: Functional Assessment of Cancer Therapy - General (FACT-G)
timeFrame: Change from date of inclusion (baseline) at 12 weeks and at 24 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Functional Assessment of Cancer Therapy: Fatigue (FACT-F)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: WHO-Five Well-Being Index (WHO-5)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Perceived Benefits of Nature Questionnaire (PBNQ)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Flourishing Scale (FS-D)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Freiburg Mindfulness Inventory (FMI)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Self-Efficacy Scale - Short Form (ASKU)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Self-Compassion Scale (SCS-D)
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Behavioral questions: alcohol consumption
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Behavioral questions: relaxation
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Behavioral questions: cigarettes
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Sociodemographic Measurements
timeFrame: Date of inclusion (baseline)
measure: Body weight
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
measure: Expectation questions
timeFrame: Date of inclusion (baseline)
measure: Behavioral questions: sport
timeFrame: Date of inclusion (baseline), after 12 weeks, after 24 weeks
Other outcomes:
measure: Qualitative interviews
timeFrame: 12 weeks and 24 weeks after inclusion
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
References: