Bewertung der Rolle der Schrittzahl bei der Vorhersage von Rückübernahme und Mortalität (STEP-CANCER)
Bewertung der Rolle der Schrittzahl bei der Vorhersage von Rückübernahme und Mortalität bei ungeplanten hospitalisierten Krebspatienten: Eine prospektive Beobachtungsstudie, 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.
Studienübersicht
Status
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Yenimahalle
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Ankara, Yenimahalle, Türkei (türkiye), 06560
- Gazi University
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Ankara, Yenimahalle, Türkei (türkiye), 06170
- Etlik City Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
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.
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Association Between Daily Step Count and Recurrent Hospitalization
Zeitfenster: 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
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Orhun Akdogan, MD, Gazi University
- Studienstuhl: Nuriye Ozdemir, Prof. Dr., Gazi University
- Studienleiter: Osman Sutcuoglu, Associate Professor, Ankara Etlik City Hospital
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- E-77082166-604.01-1070182
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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