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…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
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.
Study 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.
Intervention
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, 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.
Study burden and risks
Burden
- Burden of the study comprises time-investment, i.e., 2 visits to the study
center for measurements and participation in supervised yoga program two hours
per week for 4 months. Additionally, we ask the patients to perform yoga at
home for 30 minutes once a week. Patients will be asked to perform an online
cognitive test battery at home around baseline and end of study.
Risks
- As with any exercise, injuries can occur; to minimize the risk, the yoga
program will be supervised by a qualified yoga trainer. To ensure safety and
optimal execution of the different poses (asanas), health issues or physical
limitations that may hinder adherence will be identified during the visit at
the study center and communicated to the yoga teacher. In addition, a
one-on-one intake session with the yoga teacher will take place.
- Following blood draws, a hematoma can occur.
- Incidental findings can arise during the different measurements (e.g., blood
pressure measurement and assessment of depression), which will be reported to
participants and their treating physician when potentially clinically relevant.
Benefit
We expect that the yoga program will have a beneficial effect on the
participants* health status and may improve adherence of endocrine treatment.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | Het protocol is nog niet geregistreerd, maar dat gaan we doen voor de eerste inclusie, bij het Dutch Trial Register. |
| CCMO | NL86325.041.24 |