NCT04160182撤回不适用
Feasibility and Effectiveness of an Internet-based Intervention to Manage Fatigue in Breast Cancer Survivors
University of Toledo Health Science Campus2 个研究点 分布在 1 个国家开始时间: 2020年1月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Change in Fatigue Scores (Revised Piper Fatigue Scale)
研究概览
简要总结
The purpose of this project is to determine the feasibility and effectiveness of a 6-week, internet-based, Energy Conservation and Activity Management intervention among women who report cancer-related fatigue following breast cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •breast cancer diagnoses
- •not currently receiving active treatment in the form of chemotherapy or radiation therapy
- •at least 18 years of age
- •fatigue severe enough to limit daily activities (score ≥ 4 on 7-point Fatigue Severity Scale)(Krupp, LaRocca, Muir-Nash, & Steinberg, 1989);
- •functional English fluency and literacy;
- •Participant has a smart device that operates on the Android or Apple platform
- •Participant is able to use the Ecological Momentary Assessment application before going to bed every night
排除标准
- •self-reported history of diagnosis of co-morbidities that have been associated with poor sleep and fatigue: chronic insomnia, chronic fatigue syndrome, unstable heart, lung, or neuromuscular disease, insulin-dependent diabetes, sleep apnea, chronic oral steroid therapy, and night-shift employment,
- •Disability due to a diagnosis other then breast cancer
- •Currently taking medication for depression, sleep issues, or fatigue.
结局指标
主要结局
Change in Fatigue Scores (Revised Piper Fatigue Scale)
时间窗: Baseline to 14 weeks
Measure of fatigue severity and impact
次要结局
- Change in Fatigue Impact (Patient Reported Outcomes Measurement Information System Fatigue Scale)(Baseline to 14 weeks)
- Change in Fatigue Impact (Modified Fatigue Impact Scale)(Baseline at 14 weeks)
- Change in Severity of Fatigue Measured Via Ecological Momentary Assessments(Baseline to 14 weeks)
研究者
研究点 (2)
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