CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 410 enrolled
Drug / intervention
Standard Care Control Condition +1 moreprocedure
Likely dose
YOCAS program: 4-week yoga intervention with Gentle Hatha and Restorative yoga sessions including physical postures, breathing, and mindfulness exercisesAI-extracted
Key inclusion· 6
  • ✓Any cancer diagnosis (including >1 primary cancer)
  • ✓Completed all standard treatment (surgery, chemotherapy, radiation) 2–24 months ago
  • ✓Persistent sleep disturbance: rating ≥3 on 11-point scale
  • ✓May be on hormone therapy (tamoxifen) or monoclonal antibodies (trastuzumab/Herceptin)
Key exclusion· 4
  • ✕No regular yoga participation (≥1 day/week) or personal practice in past 3 months
  • ✕No diagnosis of sleep apnea
  • ✕No concurrent chemotherapy or radiation (hormonal therapy and monoclonal antibodies allowed)
  • ✕No metastatic cancer

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00397930
NCT00397930Phase 2Completed
CompareCT.gov

Yoga for Persistent Sleep Disturbance in Cancer Survivors

Gary Morrow·interventional·Posted Nov 10, 2006·Updated Feb 20, 2017

In Brief

A Phase 2 clinical trial evaluating Standard Care Control Condition and Yoga Intervention (YOCAS) for Fatigue and 2 related conditions. Completed, enrolled 410 participants across 11 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatigue, Cancer, Sleep Disorders
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2006
Enrollment StartOct 1, 2006
Primary CompletionApr 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 19.6 years ago

Interventions

Standard Care Control Conditionprocedure

Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.

Yoga Intervention (YOCAS)procedure

The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.