Initial Assessment of an Internet-based Symptom Management Intervention in Early Stage Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Improvement in patient-reported symptom with use of PROSPECT for 8 weeks
研究概览
简要总结
In order to determine the acceptability of a breast cancer-specific cognitive behavioral therapy intervention, as well as to obtain preliminary data to assess efficacy in managing symptoms, the investigators will ask 45 breast cancer survivors with moderate insomnia, fatigue, and/or pain to use the investigators' internet-based intervention for 8 weeks and to complete patient-reported outcomes assessments before and after the 8 week intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Stage 0-III invasive carcinoma of the breast
- •Surgical resection and axillary assessment, radiation therapy, and/or chemotherapy, as indicated, completed at least 3 months prior to enrollment.
- •Concomitant trastuzumab and anti-endocrine therapies are permitted. If taking anti-endocrine therapy must have been taking for at least 3 months prior to enrollment.
- •Must report at least one of the following:
- •Fatigue in the week prior to enrollment at least 4 on a 10 point scale (with 0 = not tired at all and 10 = extremely tired)
- •Insomnia in the week prior to enrollment
- •Pain in the week prior to enrollment at least 4 on a 10 point scale (with 0 = no pain and 10 = extremely severe pain)
- •Has access to and is able to operate a computer with internet access.
- •Able to read and understand English.
- •Willing and able to sign an informed consent document.
排除标准
- •Diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
结局指标
主要结局
Improvement in patient-reported symptom with use of PROSPECT for 8 weeks
时间窗: 8 weeks
To obtain preliminary data about the efficacy of the intervention in this patient population. The investigators will assess change in the participant's primary reported symptom (pain, insomnia, or fatigue) with 8 weeks of the intervention.
次要结局
- Acceptability of the PROSPECT intervention based on patient self-report(8 weeks)
研究者
N. Lynn Henry
Associate Professor
University of Michigan