Breast CancerMSCWNCT04193644
Mindfulness and Self-compassion Focussed Walking
A study testing Mindfulness and Self-Compassion focussed exercises during walking training and Walking training in people with Breast Cancer and Fatigue, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Fatigue
- What is being tested?
- Mindfulness and Self-Compassion focussed exercises during walking training and Walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 2 sitesGermany
- Study dates
- 8 Aug 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Charite Universitätsmedizin Berlin
Berlin, 10117
Yves Steininger, M.Sc. M.Sc., 01635820041, yves.steininger@charite.de
Andreas Ströhle, Prof., +4930450517034, andreas.stroehle@charite.de
- Recruiting
Sana-Klinikum Lichtenberg, Berlin
Berlin, 10117
Yves Steininger, M.Sc.M.Sc., +491635820041, yves.steininger@charite.de
Thomas Kasal, +491733852791, thomas.kasal@gym-tv.net
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer, Fatigue
- Being tested
- Mindfulness and Self-Compassion focussed exercises during walking training, Walking training
- Keywords
- tumor-specific fatigue syndrome, mindfulness, self-compassion
- Medical subject headings
- Breast Neoplasms, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Self-Compassion focussed exercises during walking trainingBehavioural
Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity
Walking trainingBehavioural
Walking training with moderate intensity
| Study group | Role | What they receive |
|---|---|---|
| Walking-Group | Active comparator | 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). Receives: Behavioral: Walking training |
| Mindfulness and Self-Compassion focussed Walking-Group | Experimental | 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. Receives: Behavioral: Mindfulness and Self-Compassion focussed exercises during walking training |
| TAU-Group | No intervention | Participants in this group receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor specific fatigue symptomatology
Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome
Measured: Change from baseline to 12, 24 and 52 weeks
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from baseline to 12, 24 and 52 weeks
Heart rate variability
Polar watch V800
Measured: Change from baseline to 12, 24 and 52 weeks
Alpha-Amylase
extraction from saliva measurements
Measured: Change from baseline to 12, 24 and 52 weeks
cardiac function parameters
Examination by sonography
Measured: Change from baseline to 12, 24 and 52 weeks
Immune defence
Measurement of leukocytes by blood sampling
Measured: Change from baseline to 12, 24 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start8 Aug 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Sana-Klinikum Lichtenberg, Park-Klinik Berlin Weißensee, Vivantes Klinikum am Urban, Steffen Lohrer Stiftung
- Responsible party
- Principal investigator, Yves Steininger, Charite University, Berlin, Germany
- Investigators
- Andreas Ströhle, Prof., Study director, Charite Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193644
- Sponsor's protocol ID
- MSCW2019
- Acronym
- MSCW
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2019
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Various Types of Physical Activity on Tumor-specific Symptoms of Fatigue in Breast Cancer Patients Undergoing Chemotherapy and / or Radiotherapy
- ClinicalTrials.gov ID
- NCT04193644
- Acronym / sponsor ID
- MSCW / MSCW2019
- Conditions
- Breast Cancer, Fatigue
- Keywords
- tumor-specific fatigue syndrome, mindfulness, self-compassion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Sana-Klinikum Lichtenberg, Park-Klinik Berlin Weißensee, Vivantes Klinikum am Urban, Steffen Lohrer Stiftung
- Study start
- 8 Aug 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Walking-Group | Active comparator | Behavioral: Walking trainingParticipants 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 | Experimental | Behavioral: Mindfulness and Self-Compassion focussed exercises during walking trainingParticipants 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. |
| TAU-Group | No intervention | –Participants in this group receive no intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Self-Compassion focussed exercises during walking trainingMindfulness and Self-Compassion focussed exercises during walking training with moderate intensity | Behavioural | Mindfulness and Self-Compassion focussed Walking-Group |
| Walking trainingWalking training with moderate intensity | Behavioural | Walking-Group |
Primary outcome
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
10 secondary outcomes
Disease-specific quality of life
Time frame: Change from baseline to 12, 24 and 52 weeks
Self-Compassion
Time frame: Change from baseline to 6, 12, 24 and 52 weeks
Mindfulness
Time frame: Change from baseline to 6, 12, 24 and 52 weeks
Anxiety and depression
Time frame: Change from baseline to 12, 24 and 52 weeks
Stress
Time frame: Change from baseline to 12, 24 and 52 weeks
Anxiety
Time frame: Change from baseline to 12, 24 and 52 weeks
Heart rate variability
Time frame: Change from baseline to 12, 24 and 52 weeks
Alpha-Amylase
Time frame: Change from baseline to 12, 24 and 52 weeks
cardiac function parameters
Time frame: Change from baseline to 12, 24 and 52 weeks
Immune defence
Time frame: Change from baseline to 12, 24 and 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Ströhle, Prof. study director
Charite Universitätsmedizin Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Self-Compassion focussed exercises during walking training and Walking training in people with Breast Cancer and Fatigue, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yves L. Steininger, M.Sc. M.Sc. (+491635820041, yves.steininger@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor specific fatigue symptomatology (time frame: Change from baseline to 12, 24 and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.