Breast Cancer
Conditions
Brief summary
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.
Interventions
BEHAVIORALlive yoga
following live yoga classes twice a week and using yoga video's at home once a week
BEHAVIORALlive remote yoga
The control group will be offered live remote yoga classes after the intervention period
Sponsors
UMC Utrecht
World Cancer Research Fund International
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Musculoskeletal complaints | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower extremity joint complaints | Baseline, at 4 and 8 months | Using the WOMAC questionnaire |
| Upper extremity musculoskeletal complaints | Baseline, at 4 and 8 months | Using the DASH questionnaire |
| Menopausal symptoms | Baseline, at 4 and 8 months | Using the FACT-ES questionnaire |
| Fatigue | Baseline, at 4 and 8 months | Using the MFI questionnaire |
| Sleep | Baseline, at 4 and 8 months | Using the PSQI questionnaire |
| Health-related Quality of Life (HRQoL) | Baseline, at 4 and 8 months | Using the QLQ-C30 that has functional scales, symptom scales and a global quality of life (QOL) score. A high score for a functional scale represents a high/ healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Health-related quality of life (HRQoL) | Baseline, at 4 and 8 months | Using the BR45. The QLQ-BR45 incorporates nine multi-item scales to assess body image, sexual functioning, breast satisfaction, systemic therapy side effects, arm symptoms, breast symptoms, endocrine therapy symptoms, skin mucosis symptoms, endocrine sexual symptoms. All items are scored 1 to 4. |
| Anxiety and depression | Baseline, at 4 and 8 months | Using the Hospital Anxiety and Depression Scale (HADS) where anxiety and depression are measured separately on a scale from 0-7 (Normal), 8-10 (borderline abnormal) and 11-21 (abnormal). |
| Cognitive functioning | Baseline and at 4 months | Using the Amsterdam Cognition Scan |
| Physical activity | Baseline, at 4 and 8 months | Using the Short Questionnaire to Assess Health-enhancing physical activity (SQUASH). Physical activity is measured in minutes per week. |
| Blood markers | Baseline and at 4 months | Inflammatory markers (Interleukin-6 and Interleukin-IB, tumor necrosis factor alpha (TNF-alpha) and high-sensitive C-reactive protein (hsCRP). At the end of the study we will conduct a literature review to identify the most promising biomarkers. |
| Physical strength | Baseline and at 4 months | Hand grip strength using a handgrip dynamometer. The best of three attempts will be recorded. |
| Vital signs | Baseline and at 4 months | Blood pressure and resting heart rate |
| Anthropometrics | Baseline and at 4 months | Weight and height will be combined to report BMI in kg/m\^2. Waist- and hip circumference. |
| Physical fitness | Baseline and at 4 months | Steep ramp test using a cycle ergometer |
| Safety of the yoga intervention | 0-8 months (whole study period) | (Serious) adverse events potentially related to the intervention |
| Use of pain medication | 0-8 months (whole study period) | Assessed with the BPI, questioned during the baseline and T1 visit, and self-reported with a diary |
| Compliance with endocrine treatment | 0-8 months (whole study period) | Self-reported with a diary |
| Qualitative outcome | During or after the study | Patient and teacher experiences with in-depth interviews |
Countries
Netherlands
Contacts
CONTACTEvelyn Monninkhof, Dr.
CONTACTStefanie Veenhuizen, MSc
STUDY_DIRECTORAnne May, Prof. Dr.
UMC Utrecht
Outcome results
None listed