N/A
Completed N=740
Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors
Cancer Survivor · Insomnia · Malignant Neoplasm
Source: ClinicalTrials.gov NCT02613364 ↗
Enrolled (actual)
740
Serious AEs
0.7%
Results posted
Mar 2021
Primary outcomePrimary: Mean Change in the ISI Comparing YOCAS vs. CBT-I — -3.61; -7.22; -2.19 units on a scale — p=<.0001
Summary
This randomized phase III trial compares yoga, survivorship health education program, and cognitive behavioral therapy in reducing sleep disturbance (insomnia) in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. Insomnia can increase fatigue, impair physical function, impair immune function, cause circadian rhythms (known as the biological clock) to be disrupted and decrease quality of life. Yoga may improve circadian rhythms, physical and immune function, and improve insomnia and sleep quality in cancer survivors. It is not yet known whether yoga is more effective at treating insomnia than a health education program or cognitive behavioral therapy program.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change in the ISI Comparing YOCAS vs. CBT-I |
-3.61; -7.22; -2.19 | <.0001 sig |
| PRIMARY Mean Change in the ISI Comparing YOCAS vs. Health Education |
-3.61; -7.22; -2.19 | 0.0009 sig |
| SECONDARY Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. Health Education |
-1.59; -3.82; -1.11 | 0.0700 |
| SECONDARY Mean Change in Global Sleep Quality Impairment as Measured by the Pittsburgh Sleep Quality Inventory (PSQI) Total Score Comparing YOCAS vs. CBT-I. |
-1.59; -3.82; -1.11 | <.0001 sig |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. Health Education |
395.99; 380.06; 376.27 | 0.0052 sig |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Sleep Duration Via Actigraphy Comparing YOCAS vs. CBT-I |
395.99; 380.06; 376.27 | 0.0258 sig |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. Health Education |
1.85; 1.81; 1.86 | 0.92 |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Wake After Sleep Onset Via Actigraphy Comparing YOCAS vs. CBT-I |
1.85; 1.81; 1.86 | 0.07 |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. Health Education |
81.65; 82.42; 79.38 | 0.04 sig |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Sleep Efficiency Via Actigraphy Comparing YOCAS vs. CBT-I |
81.65; 82.42; 79.38 | 0.49 |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. Health Education |
0.76; 0.74; 0.80 | 0.43 |
| SECONDARY Mean Change in Objective Symptoms of Insomnia- Sleep Latency Via Actigraphy Comparing YOCAS vs. CBT-I |
0.76; 0.74; 0.80 | 0.70 |
| SECONDARY Mean Change in the ISI Comparing YOCAS and Health Education (3 Month) |
-5.02; -7.59; -3.56 | 0.0041 sig |
| SECONDARY Mean Change in the ISI Comparing YOCAS and CBT-I (3 Month) |
-5.02; -7.59; -3.56 | <.0001 sig |
| SECONDARY Mean Change in the ISI Comparing YOCAS and Health Education (6 Month) |
-5.29; -7.93; -3.91 | 0.0108 sig |
| SECONDARY Mean Change in the ISI Comparing YOCAS and CBT-I (6 Month) |
-5.29; -7.93; -3.91 | <.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of cancer
- Have received surgery, chemotherapy, and/or radiation therapy
- Have completed all surgery, chemotherapy and/or radiation therapy within the last 2-60 months
- Meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-V criteria for insomnia and score >= 10 on the Insomnia Severity Index
- Be able to read and understand English
- Be able to provide written informed consent
Exclusion Criteria
- Have contraindications to functional testing or yoga participation according to the treating physician
- Have practiced yoga >= 1 day a week within the 3 months prior to enrolling in the study
- Be planning to start yoga on their own during the time they are enrolled in the study
- Have a confirmed diagnosis of sleep apnea or restless leg syndrome
- Be receiving any form of treatment for cancer with the exception of hormonal or biologic therapy
- Have distant metastases
Data sourced from ClinicalTrials.gov (NCT02613364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.