NCT04193644

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
135

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 10, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 9, 2022

Status Verified

March 1, 2022

Enrollment Period

3.4 years

First QC Date

November 30, 2019

Last Update Submit

March 8, 2022

Conditions

Breast CancerFatigue

Keywords

tumor-specific fatigue syndromemindfulnessself-compassion

Outcome Measures

Primary Outcomes (1)

  • Tumor specific fatigue symptomatology

    Fatigue Assessment Questionnaire (FAQ), minimum value 0, maximum value 60, higher values mean a worse outcome

    Change from baseline to 12, 24 and 52 weeks

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (3)

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).

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.

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

TAU-Group

NO INTERVENTION

Participants in this group receive no intervention.

Interventions

Mindfulness and Self-Compassion focussed exercises during walking trainingBEHAVIORAL

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

Mindfulness and Self-Compassion focussed Walking-Group
Walking trainingBEHAVIORAL

Walking training with moderate intensity

Walking-Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Charite Universitätsmedizin Berlin

Berlin, 10117, Germany

RECRUITING

Sana-Klinikum Lichtenberg, Berlin

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsFatigue

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Andreas Ströhle, Prof.

    Charite Universitätsmedizin Berlin

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

+491635820041yves.steininger@charite.de

Andreas Ströhle, Prof.

CONTACT

+4930450517034andreas.stroehle@charite.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 30, 2019

First Posted

December 10, 2019

Study Start

August 8, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

March 9, 2022

Record last verified: 2022-03

Locations

DE(2)