Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545604
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To provide a comprehensive yoga therapy CYT program to patients with ovarian fallopian tube or primary peritoneal cancer who are scheduled to receive chemotherapy and then undergo surgery Researchers want to learn about the effects of the program on patients quality of life and other outcomes described below
Detailed Description:
Primary Objectives
To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS Feasibility criteria will include consent 30 of those approached and study retention 60 rates
Secondary Objectives
Examine the effects of the CYT program on physical conditioning as assessed by the 6 min walk test 6MWT and sit to stand reps 30secSTS compared with WLC
Examine group differences in surgical outcomes including post op stay readmission rate post op morbidity surgical site infection rate transfusions and time to first chemotherapy post operatively
Examine group differences in patient-reported outcomes including QOL fatigue stress sleep disturbances mental health social support and mindfulness
Examine if there are group differences in preoperative albumin level vit D magnesium levels
Examine group differences and changes over time in microbiome biodiversity
Examine group differences in body composition sarcopenia as measured by routine abdominal CT scans
Explore the association between adherence to the components of CYT with ability to sustain behavior changes and between changes in lifestyle parameters with outcomes This will be explored both within and across groups
To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS Feasibility criteria will include consent 30 of those approached and study retention 60 rates
Secondary Objectives
Examine the effects of the CYT program on physical conditioning as assessed by the 6 min walk test 6MWT and sit to stand reps 30secSTS compared with WLC
Examine group differences in surgical outcomes including post op stay readmission rate post op morbidity surgical site infection rate transfusions and time to first chemotherapy post operatively
Examine group differences in patient-reported outcomes including QOL fatigue stress sleep disturbances mental health social support and mindfulness
Examine if there are group differences in preoperative albumin level vit D magnesium levels
Examine group differences and changes over time in microbiome biodiversity
Examine group differences in body composition sarcopenia as measured by routine abdominal CT scans
Explore the association between adherence to the components of CYT with ability to sustain behavior changes and between changes in lifestyle parameters with outcomes This will be explored both within and across groups
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