Pre-Habilitation with Mindfulness and Exercise for Patients Undergoing Radical Cystectomy (PRIMER Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of patient-reported days devoted to solitary psychological support
研究概览
简要总结
The PRIMER (Pre-Habilitation With Mindfulness and Exercise for Patients Undergoing Radical Cystectomy) trial is a pilot designed to estimate the feasibility of integrating a home-based pre-operative exercise and mindfulness program (pre-habilitation program) for patients scheduled to undergo radical cystectomy for bladder cancer in an attempt to improve both physical and psychological conditioning pre-operatively.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged ≥18 years of age
- •Good surgical candidate determined by treating surgeon
- •Histologically documented muscle invasive urothelial carcinoma of the bladder, high-risk non-muscle invasive bladder cancer, non-muscle invasive bladder cancer refractory to BCG, cisplatin ineligible muscle invasive bladder cancer receiving upfront cystectomy, urothelial carcinoma of the bladder with variant histology
- •Adequate Organ Function per protocol definition
- •ECOG performance status ≤2
- •Received medical clearance to complete cardiopulmonary exercise testing
- •Willing to use the personal or study provided devices for monitoring and performing the exercise routines.
- •Fluent in English or Spanish for the EORTC QLQ questionnaire
- •No known contraindications to high intensity exercise
排除标准
- •Contraindications to participating in aerobic exercise
- •Currently participating in an aerobic exercise program
- •New onset chest pain nor dyspnea with exertion
- •Histologically documented micropapillary or sarcomatoid bladder cancer
- •Distant metastatic carcinoma
结局指标
主要结局
Number of patient-reported days devoted to solitary psychological support
时间窗: 30 days
Patient-reported days devoted to self-directed solitary psychological support related to cancer treatment during a 30 day period pre-operatively in the pre-habilitation program group
Number of patient-reported days devoted to exercise
时间窗: 30 days
Patient-reported minutes per day devoted to high-intensity exercise during a 30 day period pre-operatively in the pre-habilitation program group
次要结局
- Dispositional mindfulness as assessed by the Mindfulness Awareness Attention Scale (MAAS)(4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively)
- Patient-reported health-related quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.(4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively)
- Perceived stress as assessed by the Perceived Stress Scale 10 (PSS 10)(4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively)
- Peak oxygen uptake as measured on cardiopulmonary exercise testing (CPET)(4-8 weeks pre-operatively, 2 weeks pre-operatively, 30 days post-operatively)
- Post-operative complication rate(30 days post-operatively)
研究者
Christine Ibilibor, MD
Assistant Professor
University of Virginia