Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer

NCT ID: NCT06545604

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-06
• Study Completion Date: 2027-06-30

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:

Primary Objective: to assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS. Feasibility criteria will include the percent of eligible patients who consent to participate (feasibility is defined as 30% of those approached and are eligible end up consenting) and study retention by the last follow-up (feasibility is defined as 60% of those undergoing surgery remaining in the study and providing some data at baseline and at last follow-up timepoint).

Secondary Objectives:

• Examine the effects of the CYT program on physical conditioning as assessed by the 2-minute step test (2MST) 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, , 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.

Conditions

Ovarian Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

WLC - Wait List Control + ERAS

Group Type: EXPERIMENTAL

Usual care supportive services including nutrition counseling per usual care

Intervention Type: OTHER

Usual care supportive services while receiving neoadjuvant chemotherapy.

CYT - Prehab Yoga Intervention + ERAS

Group Type: EXPERIMENTAL

Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation

Intervention Type: OTHER

Two visits per week with a yoga therapist while receiving neoadjuvant chemotherapy to cover dietary counseling, yoga-based movement practices, breathwork practices, mind practices, and behavioral support for the purpose of preparing patients' mind and body for a planned surgery.

Interventions

Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation

Two visits per week with a yoga therapist while receiving neoadjuvant chemotherapy to cover dietary counseling, yoga-based movement practices, breathwork practices, mind practices, and behavioral support for the purpose of preparing patients' mind and body for a planned surgery.

Intervention Type: OTHER

Usual care supportive services including nutrition counseling per usual care

Usual care supportive services while receiving neoadjuvant chemotherapy.

Intervention Type: OTHER

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. Access and ability to do virtual sessions.

9. Plan for surgical intervention at MD Anderson Cancer Center 9. 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).

5. Have a regular mind-body practice or an established yoga practice.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lois Ramondetta, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

MD Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lois Ramondetta, MD

Role: CONTACT

lramonde@mdanderson.org

(713) 745-0307

Facility Contacts

Lois Ramondetta, MD

Role: primary

lramonde@mdanderson.org

713-745-0307

Related Links

http://www.mdanderson.org

MD Anderson Cancer Center Website

Other Identifiers

NCI-2024-06338

Identifier Type: OTHER

Identifier Source: secondary_id

2024-0374

Identifier Type: -

Identifier Source: org_study_id