NCT01790789已完成不适用
Stress Reduction During Primary Adjuvant Chemotherapy for Ovarian Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
The purpose of this study is to investigate the effects of a stress reduction program on the quality of life of ovarian cancer patients during primary adjuvant chemotherapy.
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
- Single (Care Provider)
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
- •Subjects must have an initial diagnosis of ovarian, fallopian tube or primary peritoneal cancer who completed primary ovarian cancer surgery or 3 cycles of neoadjuvant chemotherapy with interval cytoreductive surgery (ICS).
- •Final pathology diagnosis of stage I-IV ovarian, fallopian tube or primary peritoneal cancer with plan to receive primary adjuvant chemotherapy or completion of chemotherapy after ICS.
- •Receive chemotherapy at the University of Wisconsin-Madison.
- •Subjects must be at least 18 years of age.
- •English-speaking
- •Subjects must be able to use audio media, and read and understand the study manual.
- •ECOG performance status 0-
- •Subjects must have a phone.
排除标准
- •Subjects participating in a meditation practice more than 1 hour per week prior to surgery and/or chemotherapy administration.
- •Subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer.
- •Subjects with diagnosis of Chronic Fatigue Syndrome (CFS).
- •Subjects unable to use audio media due to auditory dysfunction.
- •Subjects unable to read written English.
- •Subjects who are prisoners or incarcerated.
结局指标
主要结局
Fatigue
时间窗: 18 weeks (completion of chemotherapy)
Fatigue will be measured using the NIH PROMIS Cancer Fatigue survey instrument
次要结局
- Natural Killer Cell Activity(18 weeks (completion of chemotherapy))
研究者
研究点 (2)
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