Mindfulness and Self-compassion Focussed Walking (MSCW)

Charité University Medicine Berlin

Status: Unknown

Conditions: Breast Cancer; Fatigue

Treatments: Behavioral: Walking training; Behavioral: Mindfulness and Self-Compassion focussed exercises during walking training

Study type: Interventional

Funder types: Other

Identifiers

NCT04193644

MSCW2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

Walking-Group

Active Comparator group

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).

Treatment:

Behavioral: Walking training

Mindfulness and Self-Compassion focussed Walking-Group

Experimental group

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.

Treatment:

Behavioral: Mindfulness and Self-Compassion focussed exercises during walking training

TAU-Group

No Intervention group

Description:

Participants in this group receive no intervention.