Yoga During Chemotherapy Study

Developing a Yoga Intervention During Cancer Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Fatigue; Sleep Disturbance
• Intervention / Treatment: Behavioral: Yoga

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94110
      • UCSF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
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
Pain as measured by the modified Brief Pain Inventory	6 weeks
Hot Flashes as measured by the Hot Flash Related Daily Interference Scale	6 weeks
Mindfulness as measured by the Five Facet Mindfulness Questionnaire	6 weeks
Body Awareness as measured by the Multidimensional Assessment of Interoceptive Awareness	6 weeks
Coping and Self Efficacy as measured by the Coping and Self Efficacy Scale	6 weeks
Social Support as measured by single items on social support	6 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Anand Dhruva, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 14, 2019
• Last Update Submitted That Met QC Criteria: November 12, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Fatigue; Dyssomnias; Parasomnias
• Other Study ID Numbers: 15-15691; R34AT007935 (U.S. NIH Grant/Contract); 15991 (Other Identifier: University of California, San Francisco)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO