A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

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.

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Key information

Conditions

Fatigue Mental Disorders Nervous System Diseases Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbances Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Medical Center

New York, 10011, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

yoga

Other

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.

Primary outcomes

change in quality of life

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2018
Study completion: 2018
First posted: Feb 11, 2015
Registry last updated: Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed