Perioperative Stress Reduction in Ovarian Cancer (PRESERVE Trial)-A Prospective Randomized Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 13
- 主要终点
- Number of participants successfully completing over 80% of the bundled interventions
研究概览
简要总结
The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment
- •Scheduled to undergo exploratory laparotomy and PDS or IDS
- •Scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and COX2 inhibitor 7 days preoperatively
- •Age ≥18 years
- •ASA score of 1 to 3
- •Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent
排除标准
- •Chronic treatment with any β-blocker or COX inhibitor
- •Contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease)
- •Contraindication for COX2 inhibitor therapy (renal failure [creatinine level >1.5 mg/dL], significant liver failure [known cirrhosis, bilirubin level >2], active peptic disease), or current use of oral anticoagulant)
- •Contraindication for regional epidural anesthesia
- •Chronic autoimmune disease
- •Active infection
- •Minimally invasive procedure
- •Participation in another clinical trial that interferes with this study
研究组 & 干预措施
PSRB
Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.
干预措施: Mind-body resilience training (Behavioral)
PSRB
Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.
干预措施: Music therapy (Behavioral)
Standard of Care
Participants will receive usual care (study interventions not specifically recommended)
PSRB
Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.
干预措施: Propranolol (Drug)
PSRB
Participants will receive mind-body resilience training/MBRT, music therapy, propranolol and etodolac pre and post operatively. Postoperative Psychological Interventions may occur between POD 1-7 if needed.
干预措施: Etodolac (Drug)
结局指标
主要结局
Number of participants successfully completing over 80% of the bundled interventions
时间窗: 21 days after surgical procedure
The primary objective of this study is to investigate the feasibility of implementing a multimodal PSRB in women undergoing PDS or IDS for advanced EOC. This will be measured as number of patients successfully completing over 80% of the bundled interventions, including a preoperative integrative medicine session, postoperative integrative medicine session, total intravenous anesthesia on day of surgery, and perioperative beta blocker and COX2 inhibitor
次要结局
未报告次要终点