A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

Study Overview
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Brief Summary
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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.

Official Title
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A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms

Conditions
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Fatigue, Sleep Disturbances

Intervention / Treatment
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* Other: Yoga


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: start yoga classes immediately<br>12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence concurrently with the start of chemotherapy. | Other: Yoga<br>* 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.<br>|
| Active Comparator: Start yoga classes after 3 months<br>12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training that will commence 3 months after start of chemotherapy | Other: Yoga<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in quality of life | 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. | 12 weeks |