评估步数在预测再入院和死亡率中的作用 (STEP-CANCER)
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
地位
条件
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
注册 (实际的)
联系人和位置
学习地点
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Yenimahalle
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Ankara、Yenimahalle、土耳其(türkiye)、06560
- Gazi University
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Ankara、Yenimahalle、土耳其(türkiye)、06170
- Etlik City Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
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
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 |
|---|---|---|
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Association Between Daily Step Count and Recurrent Hospitalization
大体时间:6 months
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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
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
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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
研究美国 FDA 监管的设备产品
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