Musculoskeletal Cancers Remote Monitoring and Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Smart Watch
Other interventionParticipants 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.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Sarcoma patientsExperimental treatment 1 intervention
Group B: Palliative radiation for metastatic bone disease patientsExperimental treatment 1 intervention
Group C: prophylactic surgery for metastatic bone disease patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
3 months2
e-QOL post-surgery in patients with sarcoma of the lower extremity or pelvis
Time frame
3 months3
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
Time frame
3 months4
e-QOL post-surgery in patients with metastatic bone disease of the lower extremity or pelvis
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov