Clinical trial NCT02442635: Yoga During Chemotherapy Study
Official title: Developing a Yoga Intervention During Cancer Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Sleep Disturbance
Fatigue
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2015-05-13
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Sleep Disturbance as measured by the General Sleep Disturbance Scale
timeFrame: 6 weeks
Secondary outcomes:
measure: Fatigue as measured by the Lee Fatigue Scale
timeFrame: 6 weeks
Other outcomes:
measure: Quality of Life as measured by the Multidimensional Quality of Life Scale--Cancer
timeFrame: 6 weeks
measure: Depressive Symptoms as measured by the CES-D
timeFrame: 6 weeks
measure: Anxiety as measured by the Spielberger State Anxiety Inventory
timeFrame: 6 weeks
measure: Pain as measured by the modified Brief Pain Inventory
timeFrame: 6 weeks
measure: Hot Flashes as measured by the Hot Flash Related Daily Interference Scale
timeFrame: 6 weeks
measure: Mindfulness as measured by the Five Facet Mindfulness Questionnaire
timeFrame: 6 weeks
measure: Body Awareness as measured by the Multidimensional Assessment of Interoceptive Awareness
timeFrame: 6 weeks
measure: Coping and Self Efficacy as measured by the Coping and Self Efficacy Scale
timeFrame: 6 weeks
measure: Social Support as measured by single items on social support
timeFrame: 6 weeks
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Anand Dhruva, MD
role: PRINCIPAL_INVESTIGATOR
References: