The Effect of Yoga on Endocrine Therapy Induced Musculoskeletal Symptoms in Women With Breast Cancer: the COBRA Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Musculoskeletal complaints
研究概览
简要总结
Rationale: Women with hormone-receptor positive breast cancer are usually prescribed endocrine therapy for a period of 5-10 years. This treatment reduces the risk of recurrence and improves overall survival in these women. Musculoskeletal complaints are a common (~50%) negative consequence of endocrine treatment, which affects daily functioning and quality of life. These symptoms frequently result in early treatment discontinuation, which is associated with shorter disease-free survival. Musculoskeletal complaints are often pharmacologically treated with limited effect and accompanied by side-effects. Therefore, interventions to counteract musculoskeletal complaints are urgently needed in this population. A potential non-pharmacological option is yoga. In patients with osteoarthritis, there is emerging evidence that yoga is effective to reduce pain and stiffness and improve function. Yoga as treatment for musculoskeletal complaints that are associated with endocrine treatment is rarely investigated and mainly in small studies.
Objective: The objective of the proposed study is to assess the effectiveness of a 4-month yoga program compared to a waiting list control group on musculoskeletal complaints in women with hormone-positive stage I-III breast cancer receiving endocrine treatment who report musculoskeletal complaints.
Study design: The COBRA study is a randomized controlled trial with two study arms: a yoga- and a waiting list control group.
Study population: For this study, 140 women with oestrogen-receptor positive stage I-III breast cancer on endocrine treatment (aromatase inhibitors or Tamoxifen; >4 months) will be recruited. These women experience musculoskeletal complaints (>3 months) which started or exacerbated after initiation of endocrine treatment. Furthermore, eligible women did not practice yoga in the last six months and are not planning to start yoga and are not highly physically active (i.e., >150 minutes per week moderate-vigorous exercise).
Intervention: The intervention consists of two one-hour sessions/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, which is characterized by continuous slow movements linked with breathing. The waiting list control patients will be offered an online yoga program after the 4-month study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be diagnosed with oestrogen-receptor positive stage I-III breast cancer,
- •Use of aromatase inhibitors or Tamoxifen (>4 months and will continue using it for at least six months),
- •Have finished primary treatment (chemotherapy, radiotherapy, surgery) for at least 12 weeks,
- •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](16, 42))., which started or exacerbated after initiation of endocrine treatment,
- •Be stabilized on menopausal symptom medication or antidepressants for at least three months and three weeks, respectively, if applicable, and
- •Be able to read, speak and understand Dutch or English.
排除标准
- •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
- •A body mass index (BMI) of >35 kg/m2
研究组 & 干预措施
yoga group
following live yoga classes twice a week and using yoga video's at home once a week
干预措施: live yoga (Behavioral)
control group
Waiting list control group. The control group will be offered live remote yoga classes after the intervention period
干预措施: live remote yoga (Behavioral)
结局指标
主要结局
Musculoskeletal complaints
时间窗: Baseline, at 4 and 8 months
Worst of joint pain and stiffness/joint pain and stiffness severity/joint pain and stiffness interference assessed by the modified version of the BPI. The 14-item questionnaire result in three domain scores: worst pain/stiffness, pain/stiffness severity, and pain/stiffness interference over the past week, on a scale of 0 to 10. All these three domain scores of the BPI will be primary outcomes which will be tested sequentially to preserve an alpha of 0.05. The order of the sequential testing is: 1) worst pain/stiffness, 2) pain/stiffness severity and 3) pain/stiffness interference.
次要结局
- Lower extremity joint complaints(Baseline, at 4 and 8 months)
- Upper extremity musculoskeletal complaints(Baseline, at 4 and 8 months)
- Fatigue(Baseline, at 4 and 8 months)
- Blood markers(Baseline and at 4 months)
- Menopausal symptoms(Baseline, at 4 and 8 months)
- Sleep(Baseline, at 4 and 8 months)
- Quality of Life(Baseline, at 4 and 8 months)
- Safety of the yoga intervention(0-8 months (whole study period))
- Cognitive problems(Baseline, at 4 and 8 months)
- Vital signs(Baseline and at 4 months)
- Anthropometrics(Baseline and at 4 months)
- Compliance with endocrine treatment(0-8 months (whole study period))
- Anxiety and depression(Baseline, at 4 and 8 months)
- Habitual physical activity(Baseline, at 4 and 8 months)
- Physical fitness(Baseline and at 4 months)
- Use of pain medication(0-8 months (whole study period))
- Physical strength(Baseline and at 4 months)
- Health-related Quality of Life (HRQoL)(Baseline, at 4 and 8 months)
- Health-related quality of life (HRQoL)(Baseline, at 4 and 8 months)
- Cognitive functioning(Baseline and at 4 months)
- Cognitive functioning(Baseline, at 4 and 8 months)
- Physical activity(Baseline, at 4 and 8 months)
- Qualitative outcome(During or after the study)
研究者
Dr. Evelyn Moninkhof
Assistant professor
UMC Utrecht