NCT02360904

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2018

Completed
Last Updated

August 17, 2021

Status Verified

February 1, 2019

Enrollment Period

4.7 years

First QC Date

February 6, 2015

Last Update Submit

August 10, 2021

Conditions

FatigueSleep Disturbances

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

start yoga classes immediately

EXPERIMENTAL

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

Start yoga classes after 3 months

ACTIVE COMPARATOR

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

Interventions

YogaOTHER

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 monthsstart yoga classes immediately

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Medical Center

New York, New York, 10011, United States

Location

MeSH Terms

Conditions

FatigueParasomnias

Interventions

Yoga

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Theresa Shao, MD

    Beth Israel Medcial Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 6, 2015

First Posted

February 11, 2015

Study Start

April 1, 2014

Primary Completion

December 5, 2018

Study Completion

December 5, 2018

Last Updated

August 17, 2021

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)