Fatigue, Sleep Disturbances
Conditions
Brief summary
The primary aim of this study is to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga and those not receiving yoga. Secondary endpoints will include other measures of QOL such as sleep quality measured with the Pittsburg Sleep Quality Inventory (PSQI), anxiety and depression using Hospital Anxiety and Depression Scale (HADS), and adherence to yoga and to chemotherapy treatment.
Interventions
OTHERYoga
The intervention will consist of 12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training. Classes will be conducted at the Beth Israel Comprehensive Cancer Center in a closed-group format, and will be offered twice a week. Yoga mats will be provided for each patient. The maximum number of patients attending each class will be 12. The classes will combine physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). We would also encourage patient to practice yoga at home and keep a diary.
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age\>18 years * History of stage I-III breast cancer * Patient scheduled to receive or within 2 weeks of receiving intravenous chemotherapy for their breast cancers * Eastern Cooperative Oncology Group Performance status of \<3 * Ability to understand English 5.2
Exclusion criteria
* Planning to start yoga on their own within the next 12 weeks * Maintained a regular personal practice or yoga within the 3 months before enrolling onto the study * Severe chronic obstructive pulmonary disease * Class III or IV heart failure * Child C cirrhosis * End-Stage renal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in quality of life | 12 weeks | to assess and compare change in QOL during chemotherapy as measured by the Functional Assessment of Cancer Therapy-Breast (FACT-Breast) score between patients receiving yoga immediately and those start yoga 3 months later. |
Countries
United States
Outcome results
None listed