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评估步数在预测再入院和死亡率中的作用 (STEP-CANCER)

2026年9月15日 更新者:Orhun Akdoğan、Gazi University

评估步数在预测计划外住院癌症患者再入院和死亡率中的作用:一项前瞻性观察研究,STEP-CANCER

This study investigates the relationship between physical activity, heart rate, and sleep quality with recurrent hospitalizations among discharged oncology patients. Following discharge, patients will wear Huawei smartwatches to enable daily tracking of step count, heart rate, and sleep duration through a connected smartphone app. Patients will also complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index during follow-up visits. The smartwatch monitoring will occur during the first 30 days post-discharge, while overall patient follow-up will extend up to 90 days. This study aims to determine if lower levels of home mobility, as indicated by step count and other activity metrics, correlate with an increased risk of hospital readmission within the 30-90 day period.

研究概览

详细说明

This observational study aims to investigate the relationship between post-discharge mobility metrics and the likelihood of recurrent hospitalizations among oncology patients. Eligible participants include those who have completed treatment in the oncology ward and have an ECOG performance status of 0-2. Patients admitted only for day treatments or with significant mobility limitations are excluded. Each patient receives a Huawei Watch Fit 2 smartwatch at discharge to record daily step counts, heart rate, and sleep duration, monitored remotely through a smartphone application.

In addition to these mobility and physiological metrics, patient-specific factors-such as diagnosis, reason for admission, date of last treatment, cancer stage, and age-are collected, as these may influence follow-up outcomes. Participants complete the FACT Quality of Life Survey and the Pittsburgh Sleep Quality Index at two time points: prior to discharge and again at follow-up, enabling a comparative assessment of quality of life and sleep quality over time. All patients receive general walking recommendations to support their recovery.

During the first 30 days post-discharge, activity and physiological data are continuously monitored through the app. The follow-up period extends to 90 days, during which any hospital readmissions are recorded. By analyzing trends in step count, sleep patterns, and heart rate variability, the study aims to determine whether decreased home mobility is associated with a higher risk of readmission, potentially enabling earlier interventions for at-risk individuals.

Participant recruitment for this study was completed ahead of schedule due to a higher-than-anticipated rate of eligible patient enrollment. The study is currently in the follow-up phase, and data collection for outcome measures is ongoing. The anticipated primary completion date is June 15, 2025.

研究类型

观察性的

注册 (实际的)

220

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Yenimahalle
      • Ankara、Yenimahalle、土耳其(türkiye)、06560
        • Gazi University
      • Ankara、Yenimahalle、土耳其(türkiye)、06170
        • Etlik City Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

The study includes oncology patients discharged from the inpatient ward after completing their treatment regimen. Eligible participants are adults (≥18 years) with various cancer types and an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, indicating the ability to perform basic ambulatory activities. The cohort will be analyzed for the relationship between post-discharge physical activity-assessed through daily step counts, heart rate, and sleep duration-and the risk of readmission within 90 days. Exclusion criteria include patients with significant mobility limitations, cognitive or psychiatric impairments, or those admitted only for outpatient or same-day treatments.

描述

Inclusion Criteria:

  • Age: 18 years and older.
  • Oncology Ward Discharge: Patients who have been discharged from the oncology ward following inpatient treatment.
  • Cancer Diagnosis: Patients diagnosed with any form of cancer who received treatment in the oncology ward.
  • Treatment Completion: Patients who have completed their scheduled inpatient oncology treatment and have been discharged.
  • Performance Status: Patients with an ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2, indicating they are ambulatory and capable of basic physical activity.
  • Follow-Up Availability: Patients who are willing and able to participate in a 90-day follow-up period after discharge.
  • Technology Compliance: Patients who agree to wear a Huawei Watch Fit 2 smartwatch for the first 30 days post-discharge to track daily step count, heart rate, and sleep duration, and have access to a compatible smartphone for remote data monitoring.
  • Survey Participation: Patients willing to complete the FACT Quality of Life Survey and Pittsburgh Sleep Quality Index before discharge and during follow-up visits.

Exclusion Criteria:

  • Day Treatment Admissions: Patients admitted exclusively for day treatments or outpatient procedures, lacking a full inpatient admission in the oncology ward.
  • Severe Mobility Limitations: Individuals with substantial mobility impairments, rendering them unable to perform basic ambulatory activities such as walking.
  • Incompatibility with Technology Requirements: Patients who are unable or unwilling to wear the Huawei Watch Fit 2 smartwatch for data collection purposes or who lack access to a compatible smartphone for remote monitoring.
  • Non-Adherence to Follow-Up Protocol: Patients who are unwilling or unable to comply with the 90-day follow-up requirements post-discharge.
  • Incomplete Oncology Treatment Course: Individuals who have not completed the intended course of oncology treatment within the oncology ward prior to discharge.
  • Cognitive or Psychiatric Impairments: Patients with significant cognitive or psychiatric disorders that impair their ability to provide informed consent or adhere to study protocols.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Association Between Daily Step Count and Recurrent Hospitalization
大体时间:6 months

To evaluate the relationship between daily step count, as recorded by a smartwatch, and the incidence of recurrent hospitalizations within 30 to 90 days post-discharge among oncology patients. The study aims to determine if lower daily step counts are associated with an increased risk of rehospitalization.

6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Orhun Akdogan, MD、Gazi University
  • 学习椅:Nuriye Ozdemir, Prof. Dr.、Gazi University
  • 研究主任:Osman Sutcuoglu, Associate Professor、Ankara Etlik City Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年11月7日

初级完成 (实际的)

2025年6月15日

研究完成 (实际的)

2025年8月15日

研究注册日期

首次提交

2024年11月12日

首先提交符合 QC 标准的

2024年11月12日

首次发布 (实际的)

2024年11月13日

研究记录更新

最后更新发布 (实际的)

2026年9月18日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2024年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • E-77082166-604.01-1070182

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared due to privacy concerns and in alignment with ethical guidelines protecting participant confidentiality. Data sharing is restricted to maintain compliance with institutional and national regulations governing patient privacy. Currently, no plans exist to provide IPD access beyond the research team responsible for the study.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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