Breast Cancer Clinical Trial
— MSCWOfficial title:
Effects of Various Types of Physical Activity on Tumor-specific Symptoms of Fatigue in Breast Cancer Patients Undergoing Chemotherapy and / or Radiotherapy
This research study is evaluating the effects of two training programs (1. Walking, 2. Mindfulness and Self-compassion focussed Walking) on tumor-specific symptoms of fatigue in women with breast cancer undergoing chemo- and/or radiotherapy.
Status | Recruiting |
Enrollment | 135 |
Est. completion date | December 31, 2022 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charite Universitätsmedizin Berlin | Berlin | |
Germany | Sana-Klinikum Lichtenberg, Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany | Park-Klinik Berlin Weißensee, Sana-Klinikum Lichtenberg, Steffen Lohrer Stiftung, Vivantes Klinikum am Urban |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tumor specific fatigue symptomatology | Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome | Change from baseline to 12, 24 and 52 weeks | |
Secondary | Disease-specific quality of life | 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 | Change from baseline to 12, 24 and 52 weeks | |
Secondary | Self-Compassion | 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 | Change from baseline to 6, 12, 24 and 52 weeks | |
Secondary | Mindfulness | 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 | Change from baseline to 6, 12, 24 and 52 weeks | |
Secondary | Anxiety and depression | 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 | Change from baseline to 12, 24 and 52 weeks | |
Secondary | Stress | Perceived Stress Scale (PSS), minimum value 0, maximum value 40 for PSS total score, higher values mean a worse outcome | Change from baseline to 12, 24 and 52 weeks | |
Secondary | Anxiety | State-Trait Anxiety Inventory (STAI) - Trait Dimension, minimum value 10, maximum value 80 for STAI total score, higher values mean a better outcome | Change from baseline to 12, 24 and 52 weeks | |
Secondary | Heart rate variability | Polar watch V800 | Change from baseline to 12, 24 and 52 weeks | |
Secondary | Alpha-Amylase | extraction from saliva measurements | Change from baseline to 12, 24 and 52 weeks | |
Secondary | cardiac function parameters | Examination by sonography | Change from baseline to 12, 24 and 52 weeks | |
Secondary | Immune defence | Measurement of leukocytes by blood sampling | Change from baseline to 12, 24 and 52 weeks |
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