Mindfulness and Self-compassion Focussed Walking

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Various Types of Physical Activity on Tumor-specific Symptoms of Fatigue in Breast Cancer Patients Undergoing Chemotherapy and / or Radiotherapy

Conditions
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Breast Cancer, Fatigue

Intervention / Treatment
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* Behavioral: Mindfulness and Self-Compassion focussed exercises during walking training
* Behavioral: Walking training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Walking-Group<br>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). | Behavioral: Walking training<br>* Walking training with moderate intensity<br>|
| Experimental: Mindfulness and Self-Compassion focussed Walking-Group<br>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. | Behavioral: Mindfulness and Self-Compassion focussed exercises during walking training<br>* Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity<br>|
| No Intervention: TAU-Group<br>Participants in this group receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Heart rate variability | Polar watch V800 | Change from baseline to 12, 24 and 52 weeks | 
| Alpha-Amylase | extraction from saliva measurements | Change from baseline to 12, 24 and 52 weeks | 
| cardiac function parameters | Examination by sonography | Change from baseline to 12, 24 and 52 weeks | 
| Immune defence | Measurement of leukocytes by blood sampling | Change from baseline to 12, 24 and 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tumor-specific fatigue syndrome, mindfulness, self-compassion