The effect of yoga on endocrine therapy induced musculoskeletal symptoms in women with breast cancer

Conditions: breast cancer
10006291

Registration Number: NL-OMON56826

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 140

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 (>4 months and will continue using it for at
least six months),
o Have finished primary treatment (chemotherapy, radiotherapy, surgery) for at
least six 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

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 2 weeks not able to attend training sessions during the
intervention period

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Musculoskeletal complaints (assessed by the modified version of the BPI) at 4<br /><br>months, existing of 3 domains: worst pain, pain severity and pain interference.<br /><br>All three domain scores will be primary outcomes which will be tested<br /><br>sequentially to preserve an Alpha of 0.05. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints (assessed at 4 months, unless otherwise stated)<br /><br>• Lower extremity joint complaints (WOMAC)<br /><br>• Upper extremity musculoskeletal complaints (DASH)<br /><br>• Menopausal symptoms (FACT-ES)<br /><br>• Fatigue (MFI)<br /><br>• Sleep (PSQI)<br /><br>• Quality of Life (EORTC-QLQ-C30;QLQ/BR45)<br /><br>• Anxiety and depression (HADS)<br /><br>• Cognitive problems (online cognitive test battery, at home: Amsterdam<br /><br>Cognition Scan) and self-reported (FACT-COG)<br /><br>• Compliance with endocrine treatment<br /><br>• Use of pain medication<br /><br>- Pain response (composite measure of the BPI and use of pain medication)<br /><br>• Physical fitness/strength (hand grip strength/leg press/steep ramp test)<br /><br>• Habitual physical activity (SQUASH)<br /><br>• Blood markers (i.e., inflammatory markers)<br /><br>• Vital signs and anthropometrics (blood pressure and anthropometrics)<br /><br>• Safety : (serious) adverse events during the study</p><br>