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A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

Primary Purpose

Fatigue, Sleep Disturbances

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Beth Israel Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

start yoga classes immediately

Start yoga classes after 3 months

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2015
Last Updated
August 10, 2021
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02360904
Brief Title
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy
Official Title
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 5, 2018 (Actual)
Study Completion Date
December 5, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Sleep Disturbances

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
start yoga classes immediately
Arm Type
Experimental
Arm 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.
Arm Title
Start yoga classes after 3 months
Arm Type
Active Comparator
Arm 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
Intervention Type
Other
Intervention Name(s)
Yoga
Intervention Description
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 Outcome Measure Information:
Title
change in quality of life
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Shao, MD
Organizational Affiliation
Beth Israel Medcial Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

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