Sleep Disorders Prior to and During a Course of Radiotherapy for Breast Cancer and the Potential Impact of Smartphones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Number of Participants With Decreased Sleep Disorders
研究概览
简要总结
The main goal of the study is to evaluate sleep disorders in breast cancer patients prior to and during a course of radiotherapy in terms of severity of sleep disorders, distress for the patients and use of sleeping drugs, in order to evaluate the potential effect of habituation to radiotherapy during the course of treatment and generate hypotheses thereof.
The patients will be asked to complete a questionnaire prior to radiotherapy, after 5 and 15 fractions of radiotherapy, and at the end of radiotherapy. The questionnaire includes questions regarding symptoms, distress, sleep disorders and sleeping drugs. In addition, a questionnaire regarding the use of smartphones / tablets will be completed prior to radiotherapy.
Forty-eight patients with documented start of radiotherapy and with a documented completed questionnaire at baseline and at least one completed questionnaire after start of radiotherapy should be subjected to statistical analysis. Assuming that 5% of patients do not fulfil these requirements, a total of 51 patients should be enrolled to this study.
详细描述
The majority of breast cancer patients receive adjuvant radiotherapy, either following breast-conserving surgery or mastectomy. The situation that a patient needs to be irradiated may cause distress due to a sense of menace in view of the technology, fear of the exposure to radiation and fear of radiation-related adverse effects. These fears and other factors may lead to sleep disorders.
In a previous the study, cancer patients reported the most sleep disorders prior to and at the beginning of radiotherapy. The patients appeared to develop coping strategies during the treatment. In another study, an increase of insomnia was observed during the course of radiotherapy due to treatment-related side effects. In general, very little is known about the prevalence of sleep disorders prior and during a radiotherapy course. This study mainly aims to evaluate the course of sleep disorders during radiotherapy for breast cancer.
To assess the rate of patients with decrease of sleep disorders during the course of radiotherapy compared to baseline, defined as
- Decrease of severity of sleep disorders by at least 2 points on a patient self-rating scale (0=no problems; 10=maximum problems) or
- Decrease of distress caused by sleep disorders by at least 2 points on a patient self-rating scale (0=no distress; 10=maximum distress) or
- Reduction of the dose of sleeping drugs by at least 25%.
The required sample size of N=51 (including drop-outs) is set at the maximum that is deemed achievable in this study within the timeframe of the study given the size of the target population. However, with this sample size a one-sample binomial test with a one-sided significance level of 2.5% has a power of 80% to yield statistical significance if the rate of patients with decrease of sleep disorders during the course of radiotherapy compared to baseline is 25% (rate under the alternative hypothesis) and assuming that a decrease of only 10% or less has to be judged as a random, non-causal change in this uncontrolled study setting (null hypothesis). The latter rate was chosen after respective discussions with experts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient with histologically proven breast cancer
- •Indication for radiotherapy
- •Sleep disorders (i.e. at least 2 points on the sleep disorder self-rating scale)
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-2
- •Age ≥18 years
- •Written informed consent
- •Capacity of the patient to contract
排除标准
- •Pregnancy, Lactation
- •Expected non-compliance (patient unable to use the seizure diary)
结局指标
主要结局
Number of Participants With Decreased Sleep Disorders
时间窗: 3 weeks
Sleep disorders during the course of radiotherapy (assessed after 15 fractions) will be compared to sleep disorders at baseline (prior to radiotherapy).
次要结局
- Number of Participants With Decreased Sleep Disorders(3 - 6.5 weeks)
研究者
Prof Dirk Rades
Professor and Chair
University Hospital Schleswig-Holstein