Clinical trial NCT04193644: Mindfulness and Self-compassion Focussed Walking
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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Fatigue
Keywords: tumor-specific fatigue syndrome
mindfulness
self-compassion
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Sana-Klinikum Lichtenberg
name: Park-Klinik Berlin Weißensee
name: Vivantes Klinikum am Urban
name: Steffen Lohrer Stiftung
First posted: 2019-12-10
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Tumor specific fatigue symptomatology
timeFrame: Change from baseline to 12, 24 and 52 weeks
Secondary outcomes:
measure: Disease-specific quality of life
timeFrame: Change from baseline to 12, 24 and 52 weeks
measure: Self-Compassion
timeFrame: Change from baseline to 6, 12, 24 and 52 weeks
measure: Mindfulness
timeFrame: Change from baseline to 6, 12, 24 and 52 weeks
measure: Anxiety and depression
timeFrame: Change from baseline to 12, 24 and 52 weeks
measure: Stress
timeFrame: Change from baseline to 12, 24 and 52 weeks
measure: Anxiety
timeFrame: Change from baseline to 12, 24 and 52 weeks
measure: Heart rate variability
timeFrame: Change from baseline to 12, 24 and 52 weeks
measure: Alpha-Amylase
timeFrame: Change from baseline to 12, 24 and 52 weeks
measure: cardiac function parameters
timeFrame: Change from baseline to 12, 24 and 52 weeks
measure: Immune defence
timeFrame: Change from baseline to 12, 24 and 52 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Sana-Klinikum Lichtenberg, Berlin
Study officials:
affiliation: Charite Universitätsmedizin Berlin
name: Andreas Ströhle, Prof.
role: STUDY_DIRECTOR
References: