- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02360904
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy
August 10, 2021 updated by: Theresa Shao, Icahn School of Medicine at Mount Sinai
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10011
- Beth Israel Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: start yoga classes immediately
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.
|
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.
|
Active Comparator: Start yoga classes after 3 months
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Theresa Shao, MD, Beth Israel Medcial Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
December 5, 2018
Study Completion (Actual)
December 5, 2018
Study Registration Dates
First Submitted
February 6, 2015
First Submitted That Met QC Criteria
February 10, 2015
First Posted (Estimate)
February 11, 2015
Study Record Updates
Last Update Posted (Actual)
August 17, 2021
Last Update Submitted That Met QC Criteria
August 10, 2021
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 16-0656
- 025-14 (Other Identifier: Beth Israel IRB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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