Remote smartwatch monitoring of walking and daily function in bone cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with primary osteosarcoma or metastatic bone disease of the lower limbs or pelvis will wear a consumer smartwatch and use a mobile app while completing weekly electronic questionnaires. The device will collect raw sensor data (accelerometer, gyroscope, photoplethysmography) to derive gait, activity, and physiologic metrics alongside patient-reported outcomes. Investigators will analyze how these measures change during non-surgical and surgical treatment and whether the watch signals can predict mobility decline or complications. The protocol also measures feasibility by tracking adherence to wearing the watch for at least 12 hours per day and completion rates for app-based questionnaires.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* primary sarcoma or metastatic bone disease of the lower extremities or pelvis.
* undergoing evaluation for (or have recently undergone) non-surgical or surgical intervention.
* recent history of home ambulation.

Exclusion Criteria:

* under 18 years of age at the time of study enrolment
* inability to comprehend consent form and give informed consent
* no access to a smartphone (iOS or Android) to interface with watch application
* tattoos located on the skin of the wrist or forearm where the watch will be placed or other skin conditions preventing adequate sensor function
* amputation or other disease of the arm or skin that prevents wear of a smart-watch device
* inability to tolerate watch for at least 12 hours per day on at least 80% of days in a four-week period

Where it's running

• Case Comprehensive Cancer Center, Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Zachary Burke, MD
• Email: burkez@ccf.org
• Phone: 216-445-9174

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.