Mindfulness and Self-compassion Focussed Walking

Effects of Various Types of Physical Activity on Tumor-specific Symptoms of Fatigue in Breast Cancer Patients Undergoing Chemotherapy and / or Radiotherapy

Sponsors

Lead Sponsor: Charite University, Berlin, Germany

Collaborator: Sana-Klinikum Lichtenberg
Park-Klinik Berlin Weißensee
Vivantes Klinikum am Urban
Steffen Lohrer Stiftung

Source Charite University, Berlin, Germany
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.

Overall Status Recruiting
Start Date August 8, 2019
Completion Date December 31, 2022
Primary Completion Date December 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Tumor specific fatigue symptomatology Change from baseline to 12, 24 and 52 weeks
Secondary Outcome
Measure Time Frame
Disease-specific quality of life Change from baseline to 12, 24 and 52 weeks
Self-Compassion Change from baseline to 6, 12, 24 and 52 weeks
Mindfulness Change from baseline to 6, 12, 24 and 52 weeks
Anxiety and depression Change from baseline to 12, 24 and 52 weeks
Stress Change from baseline to 12, 24 and 52 weeks
Anxiety Change from baseline to 12, 24 and 52 weeks
Heart rate variability Change from baseline to 12, 24 and 52 weeks
Alpha-Amylase Change from baseline to 12, 24 and 52 weeks
cardiac function parameters Change from baseline to 12, 24 and 52 weeks
Immune defence Change from baseline to 12, 24 and 52 weeks
Enrollment 135
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Mindfulness and Self-Compassion focussed exercises during walking training

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

Arm Group Label: Mindfulness and Self-Compassion focussed Walking-Group

Intervention Type: Behavioral

Intervention Name: Walking training

Description: Walking training with moderate intensity

Arm Group Label: Walking-Group

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Andreas Ströhle, Prof. Study Director Charite Universitätsmedizin Berlin
Overall Contact

Last Name: Yves L. Steininger, M.Sc. M.Sc.

Phone: +491635820041

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
Charite Universitätsmedizin Berlin | Berlin, 10117, Germany Recruiting Yves Steininger, M.Sc. M.Sc. 01635820041 [email protected]
Sana-Klinikum Lichtenberg, Berlin | Berlin, 10117, Germany Recruiting Yves Steininger, M.Sc.M.Sc. +491635820041 [email protected]
Location Countries

Germany

Verification Date

May 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Charite University, Berlin, Germany

Investigator Full Name: Yves Steininger

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Walking-Group

Type: Active Comparator

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).

Label: Mindfulness and Self-Compassion focussed Walking-Group

Type: Experimental

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.

Label: TAU-Group

Type: No Intervention

Description: Participants in this group receive no intervention.

Acronym MSCW
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Participant)

Source: ClinicalTrials.gov