A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT02360904
Collaborator
(none)
50
1
2
56.1
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Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Yoga
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy: Effects on Quality of Life and Chemotherapy-associated Symptoms
Study Start Date :
Apr 1, 2014
Actual Primary Completion Date :
Dec 5, 2018
Actual Study Completion Date :
Dec 5, 2018

Arms and Interventions

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.

Other: Yoga
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

Other: Yoga
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.

Outcome Measures

Primary Outcome Measures

  1. change in quality of life [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beth Israel Medical Center New York New York United States 10011

Sponsors and Collaborators

  • Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Theresa Shao, MD, Beth Israel Medcial Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Theresa Shao, Assistant Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier:
NCT02360904
Other Study ID Numbers:
  • GCO 16-0656
  • 025-14
First Posted:
Feb 11, 2015
Last Update Posted:
Aug 17, 2021
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 17, 2021