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ExerciseSTEP-CANCERNCT06687330

Evaluating the Role of Step Counts in Predicting Readmission and Mortality

An observational study of Exercise and Smart Watch, run by Gazi University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Exercise, Smart Watch, Quality of Life (QOL)
What is being tested?
Tracking Mobility and Health Data with a Smartwatch in Discharged Oncology Patients to Predict Rehospitalization: A Prospective Study
Type of treatment
Medical device
How many people
220 participants
Where
2 sitesTurkey (Türkiye)
Study dates
7 Nov 2024to 15 Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites

  • Etlik City Hospital

    Ankara, Yenimahalle, 06170

  • Gazi University

    Ankara, Yenimahalle, 06560

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluating the Role of Step Counts in Predicting Readmission and Mortality in Unplanned Hospitalized Cancer Patients: A Prospective Observational Study, 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.

Read the detailed description

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.

Being tested
Tracking Mobility and Health Data with a Smartwatch in Discharged Oncology Patients to Predict Rehospitalization: A Prospective Study
Medical subject headings
Motor Activity, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tracking Mobility and Health Data with a Smartwatch in Discharged Oncology Patients to Predict Rehospitalization: A Prospective StudyDevice

    The intervention involves daily monitoring of discharged oncology patients using a smartwatch (Huawei Watch Fit 2) to track physical activity (step count), heart rate, and sleep duration. Data is collected remotely via a smartphone app, allowing real-time tracking of health metrics post-discharge. This intervention is distinct in its focus on correlating mobility and physiological data with the risk of rehospitalization within a 30-90 day period. Patients will also receive recommendations to maintain daily walking routines as part of their post-discharge care. Additionally, quality of life and sleep quality assessments are conducted before discharge and at follow-up visits to provide a comprehensive overview of each patient's post-hospital recovery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Association Between Daily Step Count and Recurrent Hospitalization

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start7 Nov 2024
  3. Primary completion15 Jun 2025
  4. Study completion15 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06687330
Sponsor's protocol ID
E-77082166-604.01-1070182
Acronym
STEP-CANCER
Status last verified
Nov 2024
First submitted
12 Nov 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • Akdogan O, Uyar GC, Bergerot CD, McCollom JW, Tuzcu TU, Yesilbas E, Umunc F, Baskurt K, Savas G, Yildirim OA, Gurler F, Yucel KB, Coskun U, Uner A, Ozet A, Yazici O, Ozdemir N, Oksuzoglu B, Sutcuoglu O. Wearable-derived postdischarge mobility as a digital biomarker for 90-day readmission and mortality in metastatic cancer. Support Care Cancer. 2026 Sep 11;34(10):959. doi: 10.1007/s00520-026-11216-6.

    PubMed 42726154

Questions about this trial

What is this clinical trial studying?

An observational study of Exercise and Smart Watch, run by Gazi University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Association Between Daily Step Count and Recurrent Hospitalization (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06687330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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