A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

Not Applicable

Completed

• Conditions: Sleep Disturbances; Fatigue
• Interventions: Other: Yoga

• Registration Number: NCT02360904
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-11
• Primary Completion: 2018-12-05
• Study Completion: 2018-12-05
• Status Verified: 2019-02
• Last Update Submitted: 2021-08-10
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Start yoga classes after 3 months	Yoga	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
start yoga classes immediately	Yoga	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Beth Israel Medical Center; 🇺🇸 New York, New York, United States