breast cancer Breast cancer
Conditions
Interventions
The intervention consists of two hours/week supervised yoga and once a week
30-minute yoga exercises at home. The 4-month yoga program will be an active
form of yoga, such as Easy Vinyasa yoga, whic
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a woman must: o Be diagnosed with oestrogen-receptor positive stage I-III breast cancer, o Use of aromatase inhibitors or Tamoxifen (>4 months and will continue using it for at least six months), o Have finished primary treatment (chemotherapy, radiotherapy, surgery) for at least twelve weeks, o Experience musculoskeletal complaints (>3 months, which are at least mild in severity (i.e., score of >= 3 for worst pain item of a modified version of the Brief Pain Inventory [BPI], which started or exacerbated after initiation of endocrine treatment, o Be stabilized on menopausal symptom medication or antidepressants for at least three months and three weeks, respectively, if applicable, and o Be able to read, speak and understand Dutch or English.
Exclusion criteria
Exclusion criteria: A woman who meets any of the following criteria will be excluded from participation in this study: - Too physically active (i.e., >150 minutes/week of self-reported moderate-to-vigorous or leisure and sports activities) - Following (during the last 6 months), or planned to follow yoga classes on a structural base - Following, or planned to follow, a structured psychological intervention during the intervention period, i.e., cognitive behavioral therapy, or unstable on psychotropic medication - Participated in the intervention group of an exercise study during breast cancer treatment - Any circumstances that would impede ability to give informed consent or adherence to study requirements as determined by the study team - More than 3 weeks not able to attend training sessions during the intervention period - Body Mass Index (BMI) > 35 kg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Musculoskeletal complaints (assessed by the modified version of the BPI) at 4 months, existing of 3 domains: worst pain, pain severity and pain interference. All three domain scores will be primary outcomes which will be tested sequentially to preserve an Alpha of 0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints (assessed at 4 months, unless otherwise stated) • Lower extremity joint complaints (WOMAC) • Upper extremity musculoskeletal complaints (DASH) • Menopausal symptoms (FACT-ES) • Fatigue (MFI) • Sleep (PSQI) • Quality of Life (EORTC-QLQ-C30;QLQ/BR45) • Anxiety and depression (HADS) • Cognitive problems (online cognitive test battery, at home: Amsterdam Cognition Scan) and self-reported (FACT-COG) • Compliance with endocrine treatment • Use of pain medication - Pain response (composite measure of the BPI and use of pain medication) • Physical fitness/strength (hand grip strength test/leg press/plank position holding test/steep ramp test) - Balance (Short-Form Fullerton Advanced Balance (FAB) scale) • Habitual physical activity (SQUASH) • Blood markers (i.e., inflammatory markers) • Vital signs and anthropometrics (blood pressure and anthropometrics) • Safety : (serious) adverse events during the study | — |
Countries
Netherlands
Contacts
Public ContactE. Monninkhof
Universitair Medisch Centrum Utrecht
Outcome results
None listed