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

Charite University, Berlin, Germany1 site in 1 country107 target enrollmentJuly 14, 2020

ConditionsCancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Charite University, Berlin, Germany
Enrollment: 107
Locations: 1
Primary Endpoint: Functional Assessment of Cancer Therapy - General (FACT-G)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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").

Registry

clinicaltrials.gov

Start Date

July 14, 2020

End Date

May 1, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Andreas Michalsen

Prof. Dr. med.

Charite University, Berlin, Germany

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

Outcomes

Primary Outcomes

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

Behavioral questions: alcohol consumption(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Behavioral questions: cigarettes(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)
Sociodemographic Measurements(Date of inclusion (baseline))
Expectation questions(Date of inclusion (baseline))
Functional Assessment of Cancer Therapy: Fatigue (FACT-F)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Body weight(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Functional Assessment of Cancer Therapy - Breast Cancer (FACT-B)(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)
Flourishing Scale (FS-D)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Hospital Anxiety and Depression Scale (HADS)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Self-Efficacy Scale - Short Form (ASKU)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Self-Compassion Scale (SCS-D)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Behavioral questions: sport(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Freiburg Mindfulness Inventory (FMI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Insomnia Severity Index (ISI)(Date of inclusion (baseline), after 12 weeks, after 24 weeks)
Behavioral questions: relaxation(Date of inclusion (baseline), after 12 weeks, after 24 weeks)