Yoga During Chemotherapy Study

Not Applicable

Completed

• Conditions: Cancer; Sleep Disturbance; Fatigue
• Interventions: Behavioral: Yoga

• Registration Number: NCT02442635
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-13
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-12
• Last Update Posted: 2019-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Condition 1	Yoga	Yoga Breathing
Condition 2	Yoga	Static Yoga
Condition 3	Yoga	Flowing Yoga

Primary Outcome Measures

Name	Time	Method
Sleep Disturbance as measured by the General Sleep Disturbance Scale	6 weeks

Secondary Outcome Measures

Name	Time	Method
Fatigue as measured by the Lee Fatigue Scale	6 weeks

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States