A Feasibility Study Followed By A Randomized Phase II Study Of Yoga For Radiation Therapy Side Effects In Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study will ascertain the feasibility and effect of Eischens yoga interventions on radiation related fatigue, sexual dysfunction and urinary incontinence in stage I /II prostate cancer patients undergoing radiotherapy with photons and/or protons without prostatectomy. Subjects must be smoke free and have not taken regular yoga classes 6 months prior to enrollment. Subjects will participate in twice weekly yoga sessions for 8 weeks and complete 4 quality of life forms 5 times during study.
详细描述
The feasibility study refers to the ability to recruit patients willing to participate in the Eischens yoga interventional arm. Those who are recruited during the feasibility study are seemlessly move to the Phase II study, and for this reason the feasibility study and Eischens yoga interventional arms are reported simply as the Eischens yoga interventional arm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer patients undergoing active radiation therapy (external beam radiation with photons and/ or protons). Prior or concurrent androgen deprivation therapy is permitted.
- •Patients of age >18 years, and all races will be included in the study.
- •Patients must have an ECOG Performance Score ≤ 1
- •All patients must sign an informed consent form
- •Subject is age >18 years
- •Subject is English-speaking
- •Subject must sign an informed consent form
- •Exclusion Criteria
- •Patients with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions per their physician orders as evaluated by ECOG Performance Status score.
- •Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
- •Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
- •Patients who are undergoing chemotherapy for any reason
- •Patients with evidence of metastatic disease
- •Subjects that are unwilling or unable to provide informed consent
- •Subjects with medical restrictions that may interfere with or prevent them from taking part in the yoga interventions
- •Active, regular cigarette smokers, such that smoking may interfere with relaxation and breathing modalities of the yoga interventions. (Smokers that have been smoke-free for 6 months may be included)
- •Patients who currently practice or have recently practiced yoga (taken a yoga class on a regular basis in the last 6 months).
排除标准
- 未提供
结局指标
主要结局
Adverse Events
时间窗: 8 weeks
次要结局
- International Prostate Symptom Score(8 weeks)
- Brief Fatigue Inventory Score(8 weeks)
- Functional Assessment of Cancer Therapy: Physical Well-Being Score(8 weeks)
- Functional Assessment of Cancer Therapy: Social Well-Being Score(8 weeks)
- Functional Assessment of Cancer Therapy: Functional Well-Being(8 weeks)
- International Index of Erectile Function Score(8 weeks)
- Functional Assessment of Cancer Therapy: Emotional Well-Being Score(8 weeks)