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Mindfulness and Self-compassion Focussed Walking (MSCW)

Primary Purpose

Breast Cancer, Fatigue

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Mindfulness and Self-Compassion focussed exercises during walking training
Walking training
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring tumor-specific fatigue syndrome, mindfulness, self-compassion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Charite Universitätsmedizin BerlinRecruiting
  • Sana-Klinikum Lichtenberg, BerlinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Walking-Group

Mindfulness and Self-Compassion focussed Walking-Group

TAU-Group

Arm Description

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).

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.

Participants in this group receive no intervention.

Outcomes

Primary Outcome Measures

Tumor specific fatigue symptomatology
Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome

Secondary Outcome Measures

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
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
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
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
Stress
Perceived Stress Scale (PSS), minimum value 0, maximum value 40 for PSS total score, higher values mean a worse outcome
Anxiety
State-Trait Anxiety Inventory (STAI) - Trait Dimension, minimum value 10, maximum value 80 for STAI total score, higher values mean a better outcome
Heart rate variability
Polar watch V800
Alpha-Amylase
extraction from saliva measurements
cardiac function parameters
Examination by sonography
Immune defence
Measurement of leukocytes by blood sampling

Full Information

First Posted
November 30, 2019
Last Updated
March 8, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
Sana-Klinikum Lichtenberg, Park-Klinik Berlin Weißensee, Vivantes Klinikum am Urban, Steffen Lohrer Stiftung
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1. Study Identification

Unique Protocol Identification Number
NCT04193644
Brief Title
Mindfulness and Self-compassion Focussed Walking
Acronym
MSCW
Official Title
Effects of Various Types of Physical Activity on Tumor-specific Symptoms of Fatigue in Breast Cancer Patients Undergoing Chemotherapy and / or Radiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Sana-Klinikum Lichtenberg, Park-Klinik Berlin Weißensee, Vivantes Klinikum am Urban, Steffen Lohrer Stiftung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Fatigue
Keywords
tumor-specific fatigue syndrome, mindfulness, self-compassion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Walking-Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Mindfulness and Self-Compassion focussed Walking-Group
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU-Group
Arm Type
No Intervention
Arm Description
Participants in this group receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Self-Compassion focussed exercises during walking training
Intervention Description
Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity
Intervention Type
Behavioral
Intervention Name(s)
Walking training
Intervention Description
Walking training with moderate intensity
Primary Outcome Measure Information:
Title
Tumor specific fatigue symptomatology
Description
Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome
Time Frame
Change from baseline to 12, 24 and 52 weeks
Secondary Outcome Measure Information:
Title
Disease-specific quality of life
Description
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
Time Frame
Change from baseline to 12, 24 and 52 weeks
Title
Self-Compassion
Description
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
Time Frame
Change from baseline to 6, 12, 24 and 52 weeks
Title
Mindfulness
Description
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
Time Frame
Change from baseline to 6, 12, 24 and 52 weeks
Title
Anxiety and depression
Description
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
Time Frame
Change from baseline to 12, 24 and 52 weeks
Title
Stress
Description
Perceived Stress Scale (PSS), minimum value 0, maximum value 40 for PSS total score, higher values mean a worse outcome
Time Frame
Change from baseline to 12, 24 and 52 weeks
Title
Anxiety
Description
State-Trait Anxiety Inventory (STAI) - Trait Dimension, minimum value 10, maximum value 80 for STAI total score, higher values mean a better outcome
Time Frame
Change from baseline to 12, 24 and 52 weeks
Title
Heart rate variability
Description
Polar watch V800
Time Frame
Change from baseline to 12, 24 and 52 weeks
Title
Alpha-Amylase
Description
extraction from saliva measurements
Time Frame
Change from baseline to 12, 24 and 52 weeks
Title
cardiac function parameters
Description
Examination by sonography
Time Frame
Change from baseline to 12, 24 and 52 weeks
Title
Immune defence
Description
Measurement of leukocytes by blood sampling
Time Frame
Change from baseline to 12, 24 and 52 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yves L. Steininger, M.Sc. M.Sc.
Phone
+491635820041
Email
yves.steininger@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Andreas Ströhle, Prof.
Phone
+4930450517034
Email
andreas.stroehle@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof.
Organizational Affiliation
Charite Universitätsmedizin Berlin
Official's Role
Study Director
Facility Information:
Facility Name
Charite Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Steininger, M.Sc. M.Sc.
Phone
01635820041
Email
yves.steininger@charite.de
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof.
Phone
+4930450517034
Email
andreas.stroehle@charite.de
Facility Name
Sana-Klinikum Lichtenberg, Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Steininger, M.Sc.M.Sc.
Phone
+491635820041
Email
yves.steininger@charite.de
First Name & Middle Initial & Last Name & Degree
Thomas Kasal
Phone
+491733852791
Email
thomas.kasal@gym-tv.net

12. IPD Sharing Statement

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Mindfulness and Self-compassion Focussed Walking

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