Comprehensive Yoga Therapy Based Lifestyle Prehabilitation Program for Women With Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with stage III-IV epithelial ovarian, fallopian tube, primary peritonal cancer with recommendations for NACT/IDS at recruitment.
- •Able to read, write, and speak English.
- •18 years of age or older.
- •Oriented to person, place, and time.
- •Access to internet connection.
- •Access to a tablet, laptop or computer or smart phone.
- •Access and ability to do virtual sessions.
- •9. Plan for surgical intervention at MD Anderson Cancer Center
- •Performance status 0-2.
排除标准
- •Have completed chemotherapy.
- •Any major thought disorder (e.g., schizophrenia, dementia).
- •Any major communication barriers that would preclude being able to complete the intervention (e.g., visually or hearing impaired).
- •Extreme mobility issues (e.g., unable to get in and out of a chair unassisted).
- •Have a regular mind-body practice or an established yoga practice.
研究组 & 干预措施
WLC - Wait List Control + ERAS
干预措施: Usual care supportive services including nutrition counseling per usual care (Other)
CYT - Prehab Yoga Intervention + ERAS
干预措施: Yoga Therapy for Nutritional, Physical, and Psychosocial Prehabilitation (Other)
结局指标
主要结局
To assess the feasibility of a CYT prehabilitation program in women with ovarian cancer scheduled to receive NACT and IDS.
时间窗: Through study completion; an average of 1 year
次要结局
未报告次要终点