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

Not Applicable

Completed

• Conditions: Cancer

• Registration Number: NCT04411251
• Lead Sponsor: Charite University, Berlin, Germany

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").

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-28
• Study First Posted: 2020-06-02
• Study Start: 2020-07-14
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-01
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy - General (FACT-G)	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 Outcome Measures

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

Trial Locations

Locations (1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus; 🇩🇪 Berlin, Germany