Mindfulness and Self-compassion Focussed Walking

NCT ID: NCT04193644

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-08

Study Completion Date

2022-12-31

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.

Conditions

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Breast Cancer Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Walking training

Intervention Type BEHAVIORAL

Walking training with moderate intensity

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.

Group Type EXPERIMENTAL

Mindfulness and Self-Compassion focussed exercises during walking training

Intervention Type BEHAVIORAL

Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity

TAU-Group

Participants in this group receive no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness and Self-Compassion focussed exercises during walking training

Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity

Intervention Type BEHAVIORAL

Walking training

Walking training with moderate intensity

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sana-Klinikum Lichtenberg

OTHER

Sponsor Role collaborator

Park-Klinik Berlin Weißensee

UNKNOWN

Sponsor Role collaborator

Vivantes Klinikum am Urban

UNKNOWN

Sponsor Role collaborator

Steffen Lohrer Stiftung

UNKNOWN

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Yves Steininger

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Ströhle, Prof.

Role: STUDY_DIRECTOR

Charite Universitätsmedizin Berlin

Locations

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Charite Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Sana-Klinikum Lichtenberg, Berlin

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Yves L. Steininger, M.Sc. M.Sc.

Role: CONTACT

+491635820041

Andreas Ströhle, Prof.

Role: CONTACT

+4930450517034

Facility Contacts

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Yves Steininger, M.Sc. M.Sc.

Role: primary

01635820041

Andreas Ströhle, Prof.

Role: backup

+4930450517034

Yves Steininger, M.Sc.M.Sc.

Role: primary

+491635820041

Thomas Kasal

Role: backup

+491733852791

Other Identifiers

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MSCW2019

Identifier Type: -

Identifier Source: org_study_id

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