Effects of Various Types of Physical Activity on Tumor-specific Symptoms of Fatigue in Breast Cancer Patients Undergoing Chemotherapy and / or Radiotherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Tumor specific fatigue symptomatology
- Last Updated
- 4 years ago
Overview
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.
Investigators
Yves Steininger
Principal Investigator
Charite University, Berlin, Germany
Eligibility Criteria
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
Outcomes
Primary Outcomes
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 Outcomes
- Anxiety and depression(Change from baseline to 12, 24 and 52 weeks)
- Immune defence(Change from baseline to 12, 24 and 52 weeks)
- Mindfulness(Change from baseline to 6, 12, 24 and 52 weeks)
- Anxiety(Change from baseline to 12, 24 and 52 weeks)
- Alpha-Amylase(Change from baseline to 12, 24 and 52 weeks)
- cardiac function parameters(Change from baseline to 12, 24 and 52 weeks)
- Self-Compassion(Change from baseline to 6, 12, 24 and 52 weeks)
- Stress(Change from baseline to 12, 24 and 52 weeks)
- Heart rate variability(Change from baseline to 12, 24 and 52 weeks)
- Disease-specific quality of life(Change from baseline to 12, 24 and 52 weeks)