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Trial Title:
Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
NCT ID:
NCT06545604
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation
Description:
Usual care supportive services including nutrition counseling per usual care
Arm group label:
CYT - Prehab Yoga Intervention + ERAS
Arm group label:
WLC - Wait List Control + ERAS
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Women with stage III-IV epithelial ovarian, fallopian tube, primary peritonal cancer
with recommendations for NACT/IDS at recruitment.
2. Able to read, write, and speak English.
3. 18 years of age or older.
4. Oriented to person, place, and time.
5. Access to internet connection.
6. Access to a tablet, laptop or computer or smart phone.
7. Plan for surgical intervention at MD Anderson Cancer Center
8. Performance status 0-2.
Exclusion Criteria:
1. Have completed chemotherapy.
2. Any major thought disorder (e.g., schizophrenia, dementia).
3. Any major communication barriers that would preclude being able to complete the
intervention (e.g., visually or hearing impaired).
4. Extreme mobility issues (e.g., unable to get in and out of a chair unassisted).
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Contact:
Last name:
Lois Ramondetta, MD
Phone:
713-745-0307
Email:
lramonde@mdanderson.org
Start date:
January 1, 2025
Completion date:
June 30, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06545604
http://www.mdanderson.org
