Yoga During Chemotherapy Study
Primary Purpose
Cancer, Sleep Disturbance, Fatigue
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- UCSF
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Condition 1
Condition 2
Condition 3
Arm Description
Yoga Breathing
Static Yoga
Flowing Yoga
Outcomes
Primary Outcome Measures
Sleep Disturbance as measured by the General Sleep Disturbance Scale
Secondary Outcome Measures
Fatigue as measured by the Lee Fatigue Scale
Full Information
NCT ID
NCT02442635
First Posted
April 30, 2015
Last Updated
November 12, 2019
Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT02442635
Brief Title
Yoga During Chemotherapy Study
Official Title
Developing a Yoga Intervention During Cancer Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Sleep disturbance is among the most common symptoms experienced by cancer patients, occurs in up to 80% of patients during chemotherapy, and results in serious impairments in quality of life. Although pharmacologic therapies improve sleep disturbance, they have numerous side effects, problems with tolerance and dependence, and are not well studied in oncology patients. While non-pharmacologic therapies may decrease sleep disturbance, the current level of evidence on their efficacy is insufficient. Fatigue occurs in up to 95% of those receiving chemotherapy, and results in major impairments in functioning and quality of life. Despite its significance, few effective treatments currently exist for fatigue. Prior studies suggest that yoga may be helpful for sleep disturbance and fatigue, but these studies have limitations. An important challenge in yoga research is that it is typically a multi-modality practice that can include physical postures, breathing practices, and/or meditation components. Prior studies have not adequately addressed the effects of individual components. Therefore, key questions remain unanswered about the most effective elements of yoga; how to best combine them for particular problems such as chemotherapy symptoms; and optimal dosing. The current study will address these gaps in the literature and perform key developmental steps to prepare for a large randomized, controlled trial (RCT). It builds on preliminary work in which yoga breathing practices during chemotherapy were found to improve sleep disturbance, showed trends toward improvements in fatigue, and were feasible to implement in patients undergoing chemotherapy. Using a mixed-methods approach to evaluate each intervention component, the investigators will pursue three closely interlinked steps in cancer patients receiving chemotherapy. In Aim 1 (n=10), the investigators will manualize an individualized approach to the yoga breathing intervention and iteratively refine it to insure feasibility and acceptability. In Aim 2 (n=20), the investigators will manualize a yoga posture intervention, evaluating both restorative/static poses and flowing poses, and perform iterative refinement to test feasibility and acceptability. In Aim 3 (n=70), the investigators will assess the final multi-modality yoga intervention to select final intervention elements and delivery methods for testing in a planned future RCT. This proposal will help to improve the treatment of debilitating cancer associated symptoms and advance approaches to developing therapeutic yoga intervention trials.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Sleep Disturbance, Fatigue
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Condition 1
Arm Type
Experimental
Arm Description
Yoga Breathing
Arm Title
Condition 2
Arm Type
Experimental
Arm Description
Static Yoga
Arm Title
Condition 3
Arm Type
Experimental
Arm Description
Flowing Yoga
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
Primary Outcome Measure Information:
Title
Sleep Disturbance as measured by the General Sleep Disturbance Scale
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fatigue as measured by the Lee Fatigue Scale
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Quality of Life as measured by the Multidimensional Quality of Life Scale--Cancer
Time Frame
6 weeks
Title
Depressive Symptoms as measured by the CES-D
Time Frame
6 weeks
Title
Anxiety as measured by the Spielberger State Anxiety Inventory
Time Frame
6 weeks
Title
Pain as measured by the modified Brief Pain Inventory
Time Frame
6 weeks
Title
Hot Flashes as measured by the Hot Flash Related Daily Interference Scale
Time Frame
6 weeks
Title
Mindfulness as measured by the Five Facet Mindfulness Questionnaire
Time Frame
6 weeks
Title
Body Awareness as measured by the Multidimensional Assessment of Interoceptive Awareness
Time Frame
6 weeks
Title
Coping and Self Efficacy as measured by the Coping and Self Efficacy Scale
Time Frame
6 weeks
Title
Social Support as measured by single items on social support
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Dhruva, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Yoga During Chemotherapy Study
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