Yoga During Chemotherapy Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Developing a Yoga Intervention During Cancer Chemotherapy

Conditions
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Cancer, Sleep Disturbance, Fatigue

Intervention / Treatment
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* Behavioral: Yoga


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition 1<br>Yoga Breathing | Behavioral: Yoga<br>* Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.<br>|
| Experimental: Condition 2<br>Static Yoga | Behavioral: Yoga<br>* Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.<br>|
| Experimental: Condition 3<br>Flowing Yoga | Behavioral: Yoga<br>* Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Disturbance as measured by the General Sleep Disturbance Scale |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue as measured by the Lee Fatigue Scale |  | 6 weeks |