A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

Mount Sinai Health System

Status: Completed

Conditions: Fatigue; Sleep Disturbances

Treatments: Other: Yoga

Study type: Interventional

Funder types: Other

Identifiers

NCT02360904

GCO 16-0656

025-14 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

start yoga classes immediately

Experimental group

Description:

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.

Treatment:

Other: Yoga

Start yoga classes after 3 months

Active Comparator group

Description:

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

Treatment:

Other: Yoga