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

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Ovarian Cancer

Treatments: Other: Usual care supportive services including nutrition counseling per usual care; Other: Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06545604

2024-0374

NCI-2024-06338 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

CYT - Prehab Yoga Intervention + ERAS

Experimental group

Treatment:

Other: Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation

WLC - Wait List Control + ERAS

Experimental group

Treatment:

Other: Usual care supportive services including nutrition counseling per usual care