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临床试验/NCT04116827
NCT04116827Unknown不适用

Analysis of Sleep and Activity Patterns in Pre-menopausal Breast Cancer Patients After Taking Tamoxifen Using a Wrist-worn Internet of Things Device

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年8月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
walking steps and walking time

研究概览

简要总结

The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.

详细描述

Breast cancer is the most common malignant tumors occurring in women worldwide. Treatments include surgery, radiation therapy, chemotherapy, hormone therapy, and target therapy. As multidisciplinary treatment improves breast cancer survival, there is a growing interest in the quality of life of breast cancer survivors. Common symptoms that patients with breast cancer continue to complain of during or after their treatment include fatigue, pain, depression, sleep disorders, weight gain and hot flashes.

There are only a few studies investigating sleep problems in breast cancer patients, which mostly relied on surveys. A commonly used survey evaluation method is the Pittsburg Sleep Quality Index (PSQI). Using PSQI, one study reported that 66% of the Chinese breast cancer survivors had sleep disorders and 49% had significantly reduced sleep efficiency and time in bed. The group with sleep disorder had lower quality of life, more depression and higher overall stress than the group without sleep disorder. Another survey of breast cancer patients over 69 years old found that pain, fatigue and depression were related to sleep, and that fatigue was the strongest predictor of sleep disorders.

A recent study found that postmenopausal breast cancer patients, starting hormone therapy with aromatase inhibitor, total sleep time and sleep efficiency declined without statistical significance. However, 58% of Korean breast cancer patients are pre-menopausal patients aged 49 or younger, and thus, most patients take tamoxifen and goserelin instead of aromatase inhibitors after surgery. In this reason, results of aromatase inhibitor can not be applied in this population. As previous studies on the effects of tamoxifen on sleep were conducted retrospectively, objective comparisons of before and after applying tamoxifen are difficult and the long-term effects of tamoxifen are difficult to understand.

The aim of this study is to observe the sleep and activity patterns of pre-menopausal breast cancer patients taking tamoxifen using a wrist-worn internet of things device and questionnaires.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • diagnosed of unilateral breast cancer (stage 0 ~III)
  • underwent proper cancer treatment including surgery, chemotherapy, radiation therapy
  • age : 18 ~ 45
  • scheduled for applying tamoxifen and goserelin

排除标准

  • need CPAP device during sleep due to sleep apnea
  • under medication for restless leg syndrome
  • previous history of tamoxifen
  • irregular bedtime due to shift work
  • diagnosed of recurrent or metastatic cancer
  • have difficulty understanding and conducting surveys and verbal instructions due to severe cognitive, communication and perception problems
  • refuse to participate
  • has musculoskeletal system and neurological damage and lesions

研究组 & 干预措施

Tamoxifen group

Pre-menopausal breast cancer patients who underwent proper surgical treatment, chemotherapy, or radiation therapy, and are scheduled for application of tamoxifen and goserelin

干预措施: Tamoxifen Oral Tablet (Drug)

结局指标

主要结局

walking steps and walking time

时间窗: study enroll~12 months

mean walking steps and walking time per day, recorded by wrist-worn IoT device

total sleep time

时间窗: study enroll~12 months

mean total sleep time per day, recorded by wrist-worn IoT device

次要结局

  • Insomnia Severity Index (ISI)(study enroll~12 months)
  • Distress thermometer(study enroll~12 months)
  • Pittsburg Sleep Quality Index (PSQI)(study enroll~12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

JiHye Hwang

Professor of Physical and Rehabilitation Medicine

Samsung Medical Center

研究点 (1)

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