Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397930
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2006-11-09
Brief Title:
Yoga in Treating Sleep Disturbance in Cancer Survivors
Sponsor:
Gary Morrow
Organization:
University of Rochester
Study Overview
Official Title:
Yoga for Persistent Sleep Disturbance in Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2017-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
YOCAS
Brief 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
PURPOSE This phase II trial is studying how well yoga works in treating sleep disturbance in cancer survivors
Detailed Description:
OBJECTIVES
Primary
Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance
OUTLINE This is a randomized multicenter study Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire 5 vs 5 Patients are randomized to 1 of 2 arms
Arm I Patients receive standard care for 6 weeks Patients may switch to the yoga intervention immediately after study completion
Arm IIPatients receive standard care for 2 weeks followed by two 75-minute sessions of Hatha yoga per week for 4 weeks
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
Primary
Determine the efficacy of Hatha yoga in improving sleep quality in cancer survivors experiencing persistent sleep disturbance
OUTLINE This is a randomized multicenter study Patients are stratified according to gender and sleep disturbance rating reported on the eligibility assessment questionnaire 5 vs 5 Patients are randomized to 1 of 2 arms
Arm I Patients receive standard care for 6 weeks Patients may switch to the yoga intervention immediately after study completion
Arm IIPatients receive standard care for 2 weeks followed by two 75-minute sessions of Hatha yoga per week for 4 weeks
PROJECTED ACCRUAL A total of 400 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| URCC-04-01 | OTHER | NCIDCP | httpsreporternihgovquickSearchU10CA037420 |
| U10CA037420 | NIH | None | None |
| URCC U3905 | OTHER | None | None |