Breast Cancer, Fatigue
Conditions
Keywords
tumor-specific fatigue syndrome, mindfulness, self-compassion
Brief summary
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.
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.
Interventions
BEHAVIORALMindfulness and Self-Compassion focussed exercises during walking training
Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity
BEHAVIORALWalking training
Walking training with moderate intensity
Sponsors
Sana-Klinikum Lichtenberg
Park-Klinik Berlin Weißensee
Vivantes Klinikum am Urban
Steffen Lohrer Stiftung
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor specific fatigue symptomatology | 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
| Measure | Time frame | Description |
|---|---|---|
| Self-Compassion | 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 |
| Mindfulness | 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 |
| Anxiety and depression | 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 |
| Stress | 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 |
| Disease-specific quality of life | 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 |
| Heart rate variability | Change from baseline to 12, 24 and 52 weeks | Polar watch V800 |
| Alpha-Amylase | Change from baseline to 12, 24 and 52 weeks | extraction from saliva measurements |
| cardiac function parameters | Change from baseline to 12, 24 and 52 weeks | Examination by sonography |
| Immune defence | Change from baseline to 12, 24 and 52 weeks | Measurement of leukocytes by blood sampling |
| Anxiety | 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 |
Countries
Germany
Contacts
Primary ContactYves L. Steininger, M.Sc. M.Sc.
Backup ContactAndreas Ströhle, Prof.
Outcome results
None listed