Mindfulness and Self-compassion Focussed Walking

Not Applicable

• Conditions: Breast Cancer; Fatigue
• Interventions: Behavioral: Walking training; Behavioral: Mindfulness and Self-Compassion focussed exercises during walking training

• Registration Number: NCT04193644
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study Start: 2019-08-08
• Study First Submitted: 2019-11-30
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-09
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Walking-Group	Walking training	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).
Mindfulness and Self-Compassion focussed Walking-Group	Mindfulness and Self-Compassion focussed exercises during walking training	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Immune defence	Change from baseline to 12, 24 and 52 weeks	Measurement of leukocytes by blood sampling
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	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
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
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
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
Heart rate variability	Change from baseline to 12, 24 and 52 weeks	Polar watch V800
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

Trial Locations

Locations (2)

Sana-Klinikum Lichtenberg, Berlin; 🇩🇪 Berlin, Germany

Charite Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany