A Yoga Program for Breast Cancer Patients Undergoing Chemotherapy

NCT ID: NCT02360904

Last Updated: 2021-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2018-12-05

Brief Summary

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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

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Conditions

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Fatigue Sleep Disturbances

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Yoga

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Yoga

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Theresa Shao

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Theresa Shao, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Medcial Center

Locations

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Beth Israel Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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025-14

Identifier Type: OTHER

Identifier Source: secondary_id

GCO 16-0656

Identifier Type: -

Identifier Source: org_study_id

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