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Imfinzi NSCLC
Imfinzi NSCLC
JOURNAL ONKOLOGIE – STUDIE
TK-Onko

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

Rekrutierend

NCT-Nummer:
NCT04411251

Studienbeginn:
Juli 2020

Letztes Update:
16.07.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
-

Kontakt

Studienlocations
(1 von 1)

Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
14109 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Miriam Rösner, Study nurse
Phone: 00493080505682
E-Mail: m.roesner@immanuel.de
» Ansprechpartner anzeigen

Studien-Informationen

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").
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

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 outcome:

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) (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. Mindfulness (Freiburger Fragebogen zur Achtsamkeit, FFA) (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. International Physical Activity Questionnaire (IPAQ) (Time Frame - Date of inclusion (baseline), after 12 weeks, after 24 weeks):
MET minutes represent the amount of energy expended carrying out physical activity. To get a continuous variable score from the IPAQ (MET minutes a week) we will consider walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS, assessing full scale, range 0-56, higher score meaning a better outcome

10. 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

11. Allgemeine Selbstwirksamkeit Kurzskala (AKSU) (Time Frame - Date of inclusion (baseline), after 12 weeks, after 24 weeks):
mean score of the 3 items, range 1-5

12. 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

13. 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

14. 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

15. 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

16. 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

17. Body weight (Time Frame - Date of inclusion (baseline), after 12 weeks, after 24 weeks):
kg

18. Waist-to-hip ratio (Time Frame - Date of inclusion (baseline), after 12 weeks, after 24 weeks):
(WHR)

19. Weekly Diary (Time Frame - 1x/week after inclusion):
exercise behaviour and severity of complaints (numeric rating scales) of the last week

20. 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)

21. 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

22. Heart Rate (HR) (Time Frame - Up to 24 weeks):
Continuous measuring by Garmin Vivosmart HR4 devices

23. Heart Rate Variability (HRV) (Time Frame - Up to 24 weeks):
Continuous measuring by Garmin Vivosmart HR4 devices

24. Number of Steps (Time Frame - Up to 24 weeks):
Continuous measuring by Garmin Vivosmart HR4 devices

Studien-Arme

  • Experimental: Outdoor
    Nature-centered therapy in a near-natural area
  • Active Comparator: Indoor
    Conventional therapy in rooms mainly in a hospital building

Geprüfte Regime

  • Nature-near integrative day care unit programme:
    Interventions based on the Mindfulness-Based Stress Reduction (MBSR) programme and complementary medicine
  • Conventional integrative day care unit programme:
    Interventions based on the Mindfulness-Based Stress Reduction (MBSR) programme and complementary medicine

Quelle: ClinicalTrials.gov


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