Clinical trial NCT06545604: Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
Official title: Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: 1. safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lois Ramondetta, MD
role: PRINCIPAL_INVESTIGATOR
References: