Mindfulness and Self-compassion Focussed Walking (MSCW)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Fatigue
• Intervention / Treatment: Behavioral: Walking training; Behavioral: Mindfulness and Self-Compassion focussed exercises during walking training

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 Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yves L. Steininger, M.Sc. M.Sc.; Phone Number: +491635820041; Email: yves.steininger@charite.de
• Study Contact Backup: Name: Andreas Ströhle, Prof.; Phone Number: +4930450517034; Email: andreas.stroehle@charite.de

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charite Universitatsmedizin Berlin
    • Contact: Andreas Ströhle, Prof.; Phone Number: +4930450517034; Email: andreas.stroehle@charite.de
    • Contact: Yves Steininger, M.Sc. M.Sc.; Phone Number: 01635820041; Email: yves.steininger@charite.de
  • Berlin, Germany, 10117
    • Recruiting
    • Sana-Klinikum Lichtenberg, Berlin
    • Contact: Yves Steininger, M.Sc.M.Sc.; Phone Number: +491635820041; Email: yves.steininger@charite.de
    • Contact: Thomas Kasal; Phone Number: +491733852791; Email: thomas.kasal@gym-tv.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Walking-Group; 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; Walking training with moderate intensity
EXPERIMENTAL: Mindfulness and Self-Compassion focussed Walking-Group; 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; Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity
NO_INTERVENTION: TAU-Group; Participants in this group receive no intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Sana-Klinikum Lichtenberg; Vivantes Klinikum am Urban; Park-Klinik Berlin Weißensee; Steffen Lohrer Stiftung
• Investigators: Study Director: Andreas Ströhle, Prof., Charite Universitatsmedizin Berlin

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: November 30, 2019
• First Submitted That Met QC Criteria: December 9, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 8, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: mindfulness; self-compassion; tumor-specific fatigue syndrome
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Fatigue
• Other Study ID Numbers: MSCW2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No