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临床试验/NCT04543799
NCT04543799招募中不适用

SIESTA: A Pilot Observational Study to Investigate and Evaluate Sleep Quality in Cancer Patients Undergoing Hormonal Therapeutic Approaches: 1) Localized, Locally Advanced or Metastatic Prostate Cancer Receiving Treatment Including Androgen Deprivation Therapy 2) Full-resected Early (Stage I-III) Breast Cancer, Ductal Carcinoma in Situ or Lobular Carcinoma in Situ, Without Evidence of Residual Disease; Proven Postmenopausal Status

Oncology Institute of Southern Switzerland1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
difference in sleep quality

研究概览

简要总结

This study will use polysomnography, alongside other methodologies such as questionnaires, actigraphic measurements and salivary melatonin samples used in previous studies to investigate sleep quality in patients with i) localized, locally advanced or metastatic hormone sensitive prostate cancer or ii) with full-resected early (stage I-III) epithelial breast cancer. The measurements will be taken before androgen deprivation therapy (ADT - for prostate cancer patients) or endocrine therapy (for breast cancer patients) is initiated, at 6 months and some measures again at 12 months.The groups, defined by cancer type and whether or not treatment includes ADT / endocrine therapy, will be compared to see if there are differences in the prevalence of the lowered sleep quality in the groups.

详细描述

The main outcomes of this pilot study can be summarised as:

  • Using a previously unused methodology to assess whether ADT / endocrine therapy may negatively affect patterns of sleep quality
  • Identifying sleep micro/macrostructure changes in prostate cancer patients receiving ADT / endocrine therapy
  • Comparing the novel methodology with results obtained previously through standard methods
  • Providing statistical underpinnings, such as sample size calculations, for a full interventional trial
  • Highlighting the most appropriate non-pharmaceutical interventions to be tested in the full interventional trial

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

difference in sleep quality

时间窗: 1 year

The two groups considered will be group A1, and group A2. This will demonstrate whether there is a difference in sleep quality between these two groups of patients. The difference between time points will establish correlation between treatment initiation and symptom onset, the between group analysis will test whether the link seems to be radiotherapy alone or whether ADT further decreases sleep quality

次要结局

未报告次要终点

研究者

发起方
Oncology Institute of Southern Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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