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Yoga During Chemotherapy Study

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ClinicalTrials.gov Identifier: NCT02442635
Recruitment Status : Completed
First Posted : May 13, 2015
Last Update Posted : November 14, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Cancer Sleep Disturbance Fatigue Behavioral: Yoga Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Developing a Yoga Intervention During Cancer Chemotherapy
Study Start Date : May 2015
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : October 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Condition 1
Yoga Breathing
Behavioral: Yoga
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.

Experimental: Condition 2
Static Yoga
Behavioral: Yoga
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.

Experimental: Condition 3
Flowing Yoga
Behavioral: Yoga
Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.




Primary Outcome Measures :
  1. Sleep Disturbance as measured by the General Sleep Disturbance Scale [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Fatigue as measured by the Lee Fatigue Scale [ Time Frame: 6 weeks ]

Other Outcome Measures:
  1. Quality of Life as measured by the Multidimensional Quality of Life Scale--Cancer [ Time Frame: 6 weeks ]
  2. Depressive Symptoms as measured by the CES-D [ Time Frame: 6 weeks ]
  3. Anxiety as measured by the Spielberger State Anxiety Inventory [ Time Frame: 6 weeks ]
  4. Pain as measured by the modified Brief Pain Inventory [ Time Frame: 6 weeks ]
  5. Hot Flashes as measured by the Hot Flash Related Daily Interference Scale [ Time Frame: 6 weeks ]
  6. Mindfulness as measured by the Five Facet Mindfulness Questionnaire [ Time Frame: 6 weeks ]
  7. Body Awareness as measured by the Multidimensional Assessment of Interoceptive Awareness [ Time Frame: 6 weeks ]
  8. Coping and Self Efficacy as measured by the Coping and Self Efficacy Scale [ Time Frame: 6 weeks ]
  9. Social Support as measured by single items on social support [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02442635


Locations
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United States, California
UCSF
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Anand Dhruva, MD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02442635     History of Changes
Other Study ID Numbers: 15-15691
R34AT007935 ( U.S. NIH Grant/Contract )
15991 ( Other Identifier: University of California, San Francisco )
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Parasomnias
Fatigue
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Neurologic Manifestations