Yoga During Chemotherapy Study
Developing a Yoga Intervention During Cancer Chemotherapy
3 other identifiers
interventional
73
1 country
1
Brief Summary
This proposal aims to expand non-pharmacologic options for the control of symptoms during chemotherapy using yoga practices. It is particularly focused on sleep disturbance with a secondary focus on fatigue.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable cancer
Started May 2015
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedFirst Posted
Study publicly available on registry
May 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2019
CompletedNovember 14, 2019
November 1, 2019
4.4 years
April 30, 2015
November 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Sleep Disturbance as measured by the General Sleep Disturbance Scale
6 weeks
Secondary Outcomes (1)
Fatigue as measured by the Lee Fatigue Scale
6 weeks
Other Outcomes (9)
Quality of Life as measured by the Multidimensional Quality of Life Scale--Cancer
6 weeks
Depressive Symptoms as measured by the CES-D
6 weeks
Anxiety as measured by the Spielberger State Anxiety Inventory
6 weeks
- +6 more other outcomes
Study Arms (3)
Condition 1
EXPERIMENTALYoga Breathing
Condition 2
EXPERIMENTALStatic Yoga
Condition 3
EXPERIMENTALFlowing Yoga
Interventions
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
Eligibility Criteria
You may qualify if:
- Age 18 and older
- Have a Karnofsky Performance Status Score of 60 or above
- Diagnosed with any cancer except acute leukemia
- Self-reported poor quality of sleep
- Receiving Chemotherapy
- Able to read, write, and understand English
- Ability to give informed consent
You may not qualify if:
- Diagnosed with brain metastasis
- Diagnosed with severe Chronic Obstructive Pulmonary Disease (COPD) or emphysema
- Have New York Heart Association class II or greater congestive heart failure
- Requiring chronic home oxygen therapy
- Diagnosed with a sleep disorder (e.g., sleep apnea or narcolepsy)
- Have received more than 3 prior chemotherapy regimens
- Receiving radiation therapy
- Has a less than 6 month life expectancy
- Regular yoga practice within the last 2 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF
San Francisco, California, 94110, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anand Dhruva, MD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2015
First Posted
May 13, 2015
Study Start
May 1, 2015
Primary Completion
October 1, 2019
Study Completion
October 1, 2019
Last Updated
November 14, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share