Effectiveness of exercise therapy against fatigue (chronic fatigue) in patients with metastatic breast cancer.
Zusammenfassung der Studie
In this study, 196 patients are randomly assigned to either the ERYT group (eurythmy therapy) or CoordiFit (gentle fitness training) (50% chance of being assigned to one group or the other). The exercise period lasts for each participant for 20 weeks, and two follow-ups (online questionnaires) are conducted after 6 and 12 months.
(BASEC)
Untersuchte Intervention
- In the ERYT group, mindful movement exercises are performed
- In the CoordiFit group, gentle fitness training is conducted
- The exercises are simple and can be learned without prior knowledge
- The exercises are tailored to the abilities and well-being of the patients
(BASEC)
Untersuchte Krankheit(en)
The study investigates whether exercise training is effective in patients with fatigue (chronic fatigue) related to metastatic breast cancer.
(BASEC)
All individuals suffering from fatigue related to metastatic breast cancer and over 18 years old can participate. (BASEC)
Ausschlusskriterien
- Hemoglobin concentration < 9g/dl - Restrictions or contraindications that, according to the assessment of the study team, could hinder prolonged follow-up or the implementation of the active study interventions (BASEC)
Studienstandort
Basel, Bern, St Gallen, Winterthur, Andere
(BASEC)
Rapperswil-Jona
(BASEC)
Sponsor
Institute of Complementary and Integrative Medicine, University of Bern
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Professor Ursula Wolf
+41 31 684 81 40
ursula.wolf@clutterunibe.chInstitute of Complementary and Integrative Medicine, University of Bern
(BASEC)
Allgemeine Auskünfte
Institute for complementary and integrative medicine
(ICTRP)
Wissenschaftliche Auskünfte
Institute for complementary and integrative medicine
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
15.10.2019
(BASEC)
ICTRP Studien-ID
NCT04024267 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Eurythmy therapy versus slow movement fitness in the treatment of fatigue in metastatic breast cancer patients: the ERYT/CoordiFit randomized controlled trial (BASEC)
Wissenschaftlicher Titel
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Öffentlicher Titel
Eurythmy Therapy (ERYT) as a Treatment Option for Fatigue in Metastatic Breast Cancer Patients (ICTRP)
Untersuchte Krankheit(en)
FatigueBreast Cancer (ICTRP)
Untersuchte Intervention
Other: Eurythmy therapyOther: CoordiFit (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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 (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Change from baseline in fatigue over the whole intervention (ICTRP)
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 (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Breast Cancer Research Foundation (ICTRP)
Weitere Kontakte
Ursula Wolf, Professor, Institute for complementary and integrative medicine (ICTRP)
Sekundäre IDs
123123 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT04024267 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar