OsteosarcomaNCT07129226
Musculoskeletal Cancers Remote Monitoring and Care
A study testing Smart Watch in people with Osteosarcoma and Metastatic Bone Disease, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteosarcoma, Metastatic Bone Disease
- What is being tested?
- Smart Watch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center, Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Zachary Burke, MD, 216-445-9174, burkez@ccf.org
Rowan Barker-Clarke, Post-Doc Fellow
About this study
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.
Read the detailed description
Wearable sensors, in the form of direct-to-consumer devices, can provide insight to allow timely, proactive, personalized interventions. Nearly 20 percent of US residents own a smart wearable device such as a FitBit or Apple watch. Increasing accessibility and affordability of wearable technology has also allowed for new possibilities to provide personalized and remote care to patients . In part due to the range of sensors in consumer devices that capture multi-modal information. For example, transdermal optical photoplethysmography provides cardiac and respiratory measurements using non-invasive blood flow data. Motion and spatial data are supplied by accelerometers and gyroscopes. These raw data can then be assembled to provide insight into biometric parameters ranging from gait symmetry and step count to higher-level information (e.g. VO2 max and sleep duration).
Our proprietary mobile application (established for Dr. Barker-Clarke's trial NCT06129760 in neurooncology) advances beyond current studies by providing access to raw sensor data and derived mobile health metrics while simultaneously providing a platform for electronic PRO questionnaires. Based on this prior study, investigator anticipate patient eligibility to enroll in this study at around 75% of the patient population, and completed enrollment of around 60% of those eligible. Additionally, having demonstrated the efficacy of our pipeline platform, investigator expects that the collection of ePROMs and actigraphy data will be successful in the patients enrolled. Investigator includes the collection of raw data and derived metrics such as gait asymmetry, breathing rate, and sleep patterns to identify potential digital signatures of recovery, fatigue, or decline that may not be captured by TESS alone. In this new cohort investigator will evaluate compliance in the collection of actigraphy data and reporting of ePROMs. Investigator will estimate effect sizes for actigraphic and gait changes through recovery and anticipate their use in quality of care management or interventional studies in larger patient cohorts. Investigator assume, based on prior studies, that a smartwatch will be able to be worn by at least 80% of the study participants for at least 12 hours per 24-hour period, on average. Investigator outline a study using consumer-grade smartwatches and an application on the patient's phone to collect continuous actigraphy data and ePRO evaluation. In the absence of similar cohort studies for retrospective analysis, investigator aims to generate novel contextualized wearable sensor datasets for musculoskeletal cancer patients and develop digital biomarkers for patient recovery and complications.
- Conditions
- Osteosarcoma, Metastatic Bone Disease
- Being tested
- Smart Watch
- Keywords
- prophylactic surgery
- Medical subject headings
- Osteosarcoma, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sarcoma patients | Experimental | Not described Receives: Other: Smart Watch |
| Palliative radiation for metastatic bone disease patients | Experimental | Not described Receives: Other: Smart Watch |
| prophylactic surgery for metastatic bone disease patients | Experimental | Not described Receives: Other: Smart Watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
e-QOL post-surgery in patients with sarcoma of the lower extremity or pelvis
Measured: 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
Measured: 3 months
e-QOL post-surgery in patients with metastatic bone disease of the lower extremity or pelvis
Measured: 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
Measured: 3 months
e-QOL post-radiation in patients with metastatic bone disease of the lower extremity or pelvis
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start12 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129226
- Sponsor's protocol ID
- CASE1725
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Cancers Remote Monitoring and Care
- ClinicalTrials.gov ID
- NCT07129226
- Acronym / sponsor ID
- CASE1725
- Conditions
- Osteosarcoma, Metastatic Bone Disease
- Keywords
- prophylactic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Wearable sensors, in the form of direct-to-consumer devices, can provide insight to allow timely, proactive, personalized interventions. Nearly 20 percent of US residents own a smart wearable device such as a FitBit or Apple watch. Increasing accessibility and affordability of wearable technology has also allowed for new possibilities to provide personalized and remote care to patients . In part due to the range of sensors in consumer devices that capture multi-modal information. For example, transdermal optical photoplethysmography provides cardiac and respiratory measurements using non-invasive blood flow data. Motion and spatial data are supplied by accelerometers and gyroscopes. These raw data can then be assembled to provide insight into biometric parameters ranging from gait symmetry and step count to higher-level information (e.g. VO2 max and sleep duration).
Our proprietary mobile application (established for Dr. Barker-Clarke's trial NCT06129760 in neurooncology) advances beyond current studies by providing access to raw sensor data and derived mobile health metrics while simultaneously providing a platform for electronic PRO questionnaires. Based on this prior study, investigator anticipate patient eligibility to enroll in this study at around 75% of the patient population, and completed enrollment of around 60% of those eligible. Additionally, having demonstrated the efficacy of our pipeline platform, investigator expects that the collection of ePROMs and actigraphy data will be successful in the patients enrolled. Investigator includes the collection of raw data and derived metrics such as gait asymmetry, breathing rate, and sleep patterns to identify potential digital signatures of recovery, fatigue, or decline that may not be captured by TESS alone. In this new cohort investigator will evaluate compliance in the collection of actigraphy data and reporting of ePROMs. Investigator will estimate effect sizes for actigraphic and gait changes through recovery and anticipate their use in quality of care management or interventional studies in larger patient cohorts. Investigator assume, based on prior studies, that a smartwatch will be able to be worn by at least 80% of the study participants for at least 12 hours per 24-hour period, on average. Investigator outline a study using consumer-grade smartwatches and an application on the patient's phone to collect continuous actigraphy data and ePRO evaluation. In the absence of similar cohort studies for retrospective analysis, investigator aims to generate novel contextualized wearable sensor datasets for musculoskeletal cancer patients and develop digital biomarkers for patient recovery and complications.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart WatchParticipants 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. | Other | Palliative radiation for metastatic bone disease patients, Sarcoma patients, prophylactic surgery for metastatic bone disease patients |
Primary outcome
Adherence Rate post surgery in patients with sarcoma of the lower extremity or pelvis
Time frame: 3 months
Adherence in each case involves averaging ≥ 12h/day wear time and completion in ≥10 out of 12 weeks of the TESS instrument
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
Adherence in each case involves averaging ≥ 12h/day wear time and completion in ≥10 out of 12 weeks of the TESS instrument
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
Adherence in each case involves averaging ≥ 12h/day wear time and completion in ≥10 out of 12 weeks of the TESS instrument
e-QOL post-radiation in patients with metastatic bone disease of the lower extremity or pelvis
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Watch in people with Osteosarcoma and Metastatic Bone Disease, run by Case Comprehensive Cancer Center at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zachary Burke, MD (216-445-9174, burkez@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Rate post surgery in patients with sarcoma of the lower extremity or pelvis (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2026.