Phase 2
Completed N=410
Yoga in Treating Sleep Disturbance in Cancer Survivors
Source: ClinicalTrials.gov NCT00397930 ↗Enrolled (actual)
410
Serious AEs
0.5%
Results posted
Mar 2015
Primary outcomePrimary: Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) — -1.96; -1.07 units on a scale — p=0.009
Summary
RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.
PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Post-Pre Change for the Pittsburgh Sleep Quality Inventory (PSQI) |
-1.96; -1.07 | 0.009 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of any type of cancer
- More than 1 primary cancer allowed
- Has undergone and completed all forms of standard treatment (surgery, chemotherapy, radiation therapy) within the past 2 to 24 months
- Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin
- Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is the worst possible sleep disturbance)
- Able to read English
- 21 years of age or older
Exclusion Criteria
- No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or maintain regular personal practice of any form of yoga within the past 3 months
- No diagnosis of sleep apnea
- No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])
- No metastatic cancer
Data sourced from ClinicalTrials.gov (NCT00397930). 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.