Brief description of trial (Data source: BASEC)
In dieser Studie werden 196 Patientinnen entweder der Gruppe ERYT (Eurythmietherapie) oder CoordiFit (sanftes Fitnesstraining) nach dem Zufallsprinzip zugeteilt (je 50% Chance der einen oder anderen Gruppe zugeteilt zu werden). Die Übungsperiode dauert für die einzelne Teilnehmerin 20 Wochen, und zwei Nachbeobachtungen (online Fragebögen) erfolgen nach 6 und 12 Monaten.
Health conditions investigated(Data source: BASEC)
Die Studie untersucht, ob Bewegungstraining bei Patientinnen mit Fatigue (chronische Müdigkeit) bei metastasierter Brustkrebserkrankung wirksam ist.
Health conditions
(Data source: WHO)
Fatigue;Breast Cancer
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
- In der ERYT-Gruppe werden achtsame Bewegungsübungen durchgeführt
- In der CoordiFit-Gruppe wird ein sanftes Fitnesstraining durchgeführt
- Die Übungen sind einfach und ohne Vorkenntnisse zu erlernen
- Die Übungen werden den Fähigkeiten und dem Befinden der Patientinnen angepasst
Interventions
(Data source: WHO)
Other: Eurythmy therapy;Other: CoordiFit
Criteria for participation in trial
(Data source: BASEC)
Es können alle Personen teilnehmen, die unter Fatigue bei metastasiertem Brustkrebserkrankung leiden und über 18 Jahre alt sind.
Exclusion criteria
(Data source: BASEC)
- Hämoglobinkonzentration < 9g/dl
- Einschränkungen oder Kontraindikationen (Gegenanzeigen), die gemäss der Einschätzung der Studienleitung, einer verlängerte Nachbeobachtung oder der Durchführung der aktiven Studieninterventionen entgegenstehen könnten
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: Female
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Female, aged 18 years or older
- Histologically or cytologically confirmed metastatic breast cancer
- FACIT-F subscale score < 34 (considered as cut-off for a diagnosis of relevant
fatigue; a score < 30 is considered as severe fatigue [83])
- Eastern Cooperative Oncology Group (ECOG) grade 1 or 2
- Ability to physically and cognitively perform an active movement therapy
- Ability to provide informed consent as documented by signature
- Ability to read, write, and speak German, French, or Italian
Exclusion Criteria:
- Inability or contraindication that would prevent prolonged follow-up, or to undergo
the investigated intervention or control intervention, in the opinion of the
investigator
- Patients with psychiatric, addictive or any disorder that prevents the patient from
adhering to the protocol requirements, in the opinion of the investigator
- Significant uncontrolled cardiac disease (e.g. unstable angina, recent myocardial
infarction)
- Haemoglobin < 90 g/L
-
Further information on trial
Recruitment status
Active, not recruiting
Academic title
(Data source: WHO)
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Change from baseline in fatigue over the whole intervention
Secundary end point
(Data source: WHO)
Change from baseline in quality of life over the whole intervention;Change from baseline in patient's distress over the whole intervention;Change from baseline in sleep quality over the whole intervention;Change from baseline in pain over the whole intervention;Change from baseline in depression over the whole intervention;Change from baseline in anxiety over the whole intervention
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Bern, Rapperswil-Jona, St. Gallen, Winterthur
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Professor Ursula Wolf
+41 31 684 81 40
ursula.wolf@unibe.ch
Contact for general information
(Data source: WHO)
Ursula Wolf, Professor
Institute for complementary and integrative medicine
Contact for scientific information
(Data source: WHO)
Ursula Wolf, Professor
Institute for complementary and integrative medicine
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Bern
Date of authorisation by the ethics committee
15.10.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01455
Secondary ID (Data source: WHO)
123123
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