Recruiting

Observational Study

Sponsor:

Case Comprehensive Cancer Center

Code:

NCT07129226

Conditions

Osteosarcoma

Metastatic Bone Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Smart Watch

Study Details

Brief summary:

This study aims to evaluate how walking stability and the ability to perform daily activities change during cancer treatment, and whether a smartwatch can detect these changes. The goal is to develop proactive, personalized tools that automatically monitor treatment response and predict potential complications. To support future implementation, the study will assess the feasibility of wearing a smartwatch for at least 12 hours per day, using a mobile application, and completing weekly questionnaires among patients with primary osteosarcoma or metastatic bone disease.

Conditions

Osteosarcoma

Metastatic Bone Disease

Study ID

NCT07129226

Start date

Feb 12, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Sarcoma patients

experimental: Palliative radiation for metastatic bone disease patients

experimental: prophylactic surgery for metastatic bone disease patients

Interventions

Smart Watch

Participants will be asked to wear the smartwatch daily, for at least 12 hours per day during the 12-week study period, with breaks to recharge the watch as needed.

Primary outcome measure

  • Adherence Rate post surgery in patients with sarcoma of the lower extremity or pelvis [ Time Frame: 3 months ]
  • e-QOL post-surgery in patients with sarcoma of the lower extremity or pelvis [ Time Frame: 3 months ]
  • Adherence Rate post surgery in patients with metastatic bone disease of the lower extremity or pelvis [ Time Frame: 3 months ]
  • e-QOL post-surgery in patients with metastatic bone disease of the lower extremity or pelvis [ Time Frame: 3 months ]
  • Adherence Rate post-radiation in patients with metastatic bone disease of the lower extremity or pelvis [ Time Frame: 3 months ]
  • e-QOL post-radiation in patients with metastatic bone disease of the lower extremity or pelvis [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Zachary Burke, MD

216-445-9174burkez@ccf.org

Locations

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Zachary Burke, MD

216-445-9174burkez@ccf.org

More Information

Sponsor

Case Comprehensive Cancer Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • prophylactic surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Case Comprehensive Cancer Center on 2026-08-06.