NCT07129226

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

August 5, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

February 11, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

August 5, 2025

Last Update Submit

April 14, 2026

Conditions

OsteosarcomaMetastatic Bone Disease

Keywords

prophylactic surgery

Outcome Measures

Primary Outcomes (6)

  • Adherence Rate post surgery in patients with sarcoma of the lower extremity or pelvis

    Adherence in each case involves averaging ≥ 12h/day wear time and completion in ≥10 out of 12 weeks of the TESS instrument

    3 months

  • e-QOL post-surgery in patients with sarcoma of the lower extremity or pelvis

    3 months

  • Adherence Rate post surgery in patients with metastatic bone disease of the lower extremity or pelvis

    Adherence in each case involves averaging ≥ 12h/day wear time and completion in ≥10 out of 12 weeks of the TESS instrument

    3 months

  • e-QOL post-surgery in patients with metastatic bone disease of the lower extremity or pelvis

    3 months

  • Adherence Rate post-radiation in patients with metastatic bone disease of the lower extremity or pelvis

    Adherence in each case involves averaging ≥ 12h/day wear time and completion in ≥10 out of 12 weeks of the TESS instrument

    3 months

  • e-QOL post-radiation in patients with metastatic bone disease of the lower extremity or pelvis

    3 months

Study Arms (3)

Sarcoma patients

EXPERIMENTAL
Other: Smart Watch

Palliative radiation for metastatic bone disease patients

EXPERIMENTAL
Other: Smart Watch

prophylactic surgery for metastatic bone disease patients

EXPERIMENTAL
Other: Smart Watch

Interventions

Smart WatchOTHER

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.

Palliative radiation for metastatic bone disease patientsSarcoma patientsprophylactic surgery for metastatic bone disease patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Comprehensive Cancer Center, Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

OsteosarcomaBone Diseases

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsSarcomaMusculoskeletal Diseases

Central Study Contacts

Zachary Burke, MD

CONTACT

216-445-9174burkez@ccf.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 19, 2025

Study Start

February 11, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)