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JOURNAL ONKOLOGIE – STUDIE
MSCW

Mindfulness and Self-compassion Focussed Walking

Rekrutierend

NCT-Nummer:
NCT04193644

Studienbeginn:
August 2019

Letztes Update:
09.03.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms, Fatigue

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Charite University, Berlin, Germany

Collaborator:
Sana-Klinikum Lichtenberg, Park-Klinik Berlin Weißensee, Vivantes Klinikum am Urban, Steffen Lohrer Stiftung,

Studienleiter

Andreas Ströhle, Prof.
Study Director
Charite Universitätsmedizin Berlin

Kontakt

Studienlocations
(2 von 2)

Charite Universitätsmedizin Berlin
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yves Steininger, M.Sc. M.Sc.
Phone: 01635820041
E-Mail: yves.steininger@charite.de

Andreas Ströhle, Prof.
Phone: +4930450517034
E-Mail: andreas.stroehle@charite.de
» Ansprechpartner anzeigen
Sana-Klinikum Lichtenberg, Berlin
10117 Berlin
(Berlin)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Yves Steininger, M.Sc.M.Sc.
Phone: +491635820041
E-Mail: yves.steininger@charite.de

Thomas Kasal
Phone: +491733852791
E-Mail: thomas.kasal@gym-tv.net
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

This randomized research study is evaluating the effects of two training programs (1.

Walking, 2. Mindfulness and Self-compassion focussed Walking (MSCW)) on tumor-specific

symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy. The

results of both groups are compared with each other and with those of a control group.

The MSCW program combines endurance based physical activity in the form of medically

controlled walking, as well as standardized, evidence-based mindfulness exercise elements in

a training program.

The participants of both active groups (Walking and MSCW) practice for 12 weeks, once a week

for 60 minutes under the guidance of a trainer in a group and 2 additional times (60 minutes

each) independently at home.

The purpose of this study is to prevent a sharp decline in quality of life due to fatigue

symptoms by participating in the MSCW training program.

A total of 135 participants will be included in the study. All participants are followed for

1 year.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patients diagnosed with breast cancer who have started antineoplastic therapy

(chemotherapy / radiotherapy).

- Age ≥18 years

- The patient must be able to perform the study intervention (physically and

psychologically).

- oral and written consent to participate in the study.

Exclusion Criteria:

- distant metastases

- Severe mental and / or additional organic illnesses

- Clinically relevant cardiac arrhythmias or angina pectoris

- Severe pulmonary disease

- inadequate walking ability or gait disturbance (including neurological deficits,

endoprosthesis supply that lead to gait insecurity)

- regular meditation practice (several times a week)

- Planned start of meditation, relaxation, MBSR, yoga, Qi Gong courses over the next 24

weeks.

- Participation in other intervention studies on walking or meditation

- Insufficient knowledge of the German language

Studien-Rationale

Primary outcome:

1. Tumor specific fatigue symptomatology (Time Frame - Change from baseline to 12, 24 and 52 weeks):
Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome



Secondary outcome:

1. Disease-specific quality of life (Time Frame - Change from baseline to 12, 24 and 52 weeks):
Functional Assessment of Cancer Therapy - Breastcancer (FACT-B), minimum value 0, maximum value 148 for FACT-B total score, minimum value 0, maximum value 28 for subscores, higher values mean a better outcome

2. Self-Compassion (Time Frame - Change from baseline to 6, 12, 24 and 52 weeks):
Self-Compassion Scale German (SCS-D), minimum value 1, maximum value 5 for SCS-D total score, minimum value 1, maximum value 5 for subscores, higher values mean a better outcome

3. Mindfulness (Time Frame - Change from baseline to 6, 12, 24 and 52 weeks):
Southampton Mindfulness Questionnaire (SMQ), minimum value 0, maximum value 96 for SMQ total score, minimum value 0, maximum value 24 for subscores, higher values mean a better outcome

4. Anxiety and depression (Time Frame - Change from baseline to 12, 24 and 52 weeks):
Hospital Anxiety and Depression Scale (HADS), minimum value 0, maximum value 42 for HADS total score, minimum value 0, maximum value 21 for subscores, higher values mean a worse outcome

5. Stress (Time Frame - Change from baseline to 12, 24 and 52 weeks):
Perceived Stress Scale (PSS), minimum value 0, maximum value 40 for PSS total score, higher values mean a worse outcome

6. Anxiety (Time Frame - Change from baseline to 12, 24 and 52 weeks):
State-Trait Anxiety Inventory (STAI) - Trait Dimension, minimum value 10, maximum value 80 for STAI total score, higher values mean a better outcome

7. Heart rate variability (Time Frame - Change from baseline to 12, 24 and 52 weeks):
Polar watch V800

8. Alpha-Amylase (Time Frame - Change from baseline to 12, 24 and 52 weeks):
extraction from saliva measurements

9. cardiac function parameters (Time Frame - Change from baseline to 12, 24 and 52 weeks):
Examination by sonography

10. Immune defence (Time Frame - Change from baseline to 12, 24 and 52 weeks):
Measurement of leukocytes by blood sampling

Studien-Arme

  • Active Comparator: Walking-Group
    Participants in this group walk 45 minutes 3 times a week (plus 15 minutes of warm up and cool-down) in a moderate intensity range (64-76% HRmax).
  • Experimental: Mindfulness and Self-Compassion focussed Walking-Group
    Participants in this group walk 45 minutes 3 times a week (plus 15 minutes of warm up and cool-down) in a moderate intensity range (64-76% HRmax) and additionally practice mindfulness exercises and self-compassion exercises during the 60 minutes.
  • No Intervention: TAU-Group
    Participants in this group receive no intervention.

Geprüfte Regime

  • Mindfulness and Self-Compassion focussed exercises during walking training:
    Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity
  • Walking training:
    Walking training with moderate intensity

Quelle: ClinicalTrials.gov


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