Cancer related fatigue (CRF) is the most burdening symptom in breast cancer patients, and prevalence exceeds 75% in patients with metastatic disease. CRF is described as the symptom that has the largest impact on quality of life, with negative effects on work, social activities, and daily activities, and may lead to treatment discontinuation. Currently, there is no gold standard for the treatment of CRF. Drug therapies are not satisfactory. Since physical activity is associated with significant reduction in CRF, patients are encouraged to engage in an at least moderate level of physical activity. However, for many metastatic breast cancer patients this is too burdensome. Finally, there is some evidence that non-pharmacological mind-body techniques may be beneficial in reducing CRF, yet the available data do not allow for final recommendations. Given the high prevalence of CRF and the substantial distress for patients, advancing treatment options for patients with CRF is highly desirable. In the present study, patients with metastatic breast cancer will be randomly assigned to two different non-pharmacological treatments for fatigue: Eurythmy therapy (ERYT), a standardized active mindful movement therapy, or a movement program without mindfulness features (CoordiFit). It will be tested, if ERYT has a superior benefit on fatigue compared to CoordiFit over the period of the intervention (20 weeks). Further, the benefit of ERYT on quality of life, sleep quality, anxiety, depression, pain, mobility of the arm, rate of return to work, compliance with ERYT, and targeted metabolomics will be investigated. Both groups will have equal frequency and duration of the training sessions. Each patient will receive 13 standardized therapy sessions of 45 min (once a week for 6 weeks and once every second week) during the total period of 20 weeks. The proposed study has been developed in the Breast Cancer Project Group of the Swiss Group for Clinical Cancer Research (SAKK) and is supported by many breast centers, because they realize that the patients value non-pharmacological treatment options and would be keen to participate in such a trial. If ERYT proves to be beneficial, the impact of this trial will be high and will have implications not only for metastatic breast cancer patients but also for other cancer patients, health care personnel, scientists and funding and regulatory bodies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
19
Mind-body therapy
Fitness training
Brustzentrum Basel Bethesda Spital
Basel, Switzerland
St. Clara Forschung AG
Basel, Switzerland
Engeriedspital
Bern, Switzerland
University Hospital Bern
Bern, Switzerland
Institute of Complementary and Integrative Medicine, University of Bern
Bern, Switzerland
Hirslanden Bern AG, Salem-Spital, Brustzentrum Bern Biel
Bern, Switzerland
Tumorzentrum ZeTuP Rapperswil-Jona
Rapperswil-Jona, Switzerland
Tumor- und Brustzentrum ZeTuP AG
Sankt Gallen, Switzerland
Kantonsspital St.Gallen, Zentrum für Integrative Medizin
Sankt Gallen, Switzerland
Brustzentrum Ostschweiz AG
Sankt Gallen, Switzerland
...and 1 more locations
Change from baseline in fatigue over the whole intervention
Fatigue is measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). FACIT-F consists of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the fatigue subscale comprising 13 fatigue-related items, with a total of 41 items. The fatigue subscale score is ranging from 8 to 44. A score \< 34 is considered as cut-off for a diagnosis of relevant fatigue.
Time frame: End of the intervention (week 20)
Change from baseline in quality of life over the whole intervention
Quality of life is measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). FACIT-F consists of the Functional Assessment of Cancer Therapy - General (FACT-G) plus the fatigue subscale comprising 13 fatigue-related items, with a total of 41 items. The FACT-G subscale score ranges from 0 to 108. The higher the FACT-G subscale score the better the quality of life.
Time frame: End of the intervention (week 20)
Change from baseline in patient's distress over the whole intervention
Patient's distress is measured using the National Comprehensive Cancer Network (NCCN) Distress thermometer. The NCCN Distress thermometer ranges from 0 to 10, with 10 indicating an extreme distress and 0 indicating no distress.
Time frame: End of the intervention (week 20)
Change from baseline in sleep quality over the whole intervention
Sleep quality is measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI total score of the 9 items ranges from 0 to 21. A score \< or = 5 is associated with good sleep quality; a score \> 5 is associated with poor sleep quality.
Time frame: End of the intervention (week 20)
Change from baseline in pain over the whole intervention
Pain is measured using the Brief Pain Inventory (BPI). The BPI assesses pain at its "worst", "least", "average", and "now" (current pain). The four severity items range from 0 ("no pain") to 10 ("pain as bad as you can imagine").
Time frame: End of the intervention (week 20)
Change from baseline in depression over the whole intervention
Depression is assessed using the Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 total score for the nine items ranges from 0 to 27. Scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively.
Time frame: End of the intervention (week 20)
Change from baseline in anxiety over the whole intervention
Anxiety disorders are assessed using the General Anxiety Disorder-7 (GAD-7). The GAD-7 total score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cutpoints for mild, moderate, and severe anxiety, respectively.
Time frame: End of the intervention (week 20)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.