Wearable sensors and digital health in early cancer trials
Official title: Feasibility and Acceptability of Wearable Sensors and ePROs in Early Phase Clinical Trials
Run by Case Comprehensive Cancer Center · NCT07541365 · Data updated 2026-11-12
This pilot study tests whether wearable activity tracking and electronic patient-reported outcomes can be feasibly used in early-phase cancer trials for adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Status | Recruiting |
| Started | July 8, 2026 |
| Main results expected | December 2026 |
| Study ends | January 2027 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT07541365 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with cancer who are enrolled in an early-phase clinical trial at the Case Comprehensive Cancer Center / Cleveland Clinic and can use a compatible smartwatch and mobile app.
✕Probably not a fit
Patients who do not use or have access to a compatible smartphone or smartwatch, or who cannot commit to wearing the device for four weeks, may not benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-arm, prospective pilot study to see if wearable actigraphy and ePRO data can be feasibly collected and accepted in early-phase oncology trials at the Cleveland Clinic Novel Therapeutics Clinic. Participants will use a smartwatch and a study app (they may use their own device) for four weeks to continuously monitor activity and PROMs. The study aims to lay groundwork for larger trials that integrate digital health tools into early-phase cancer research, with careful consideration of data ownership, privacy, and usability. Standard oncology symptom grading will be complemented by real-time wearable-derived metrics to capture patient experience alongside traditional assessments.
Why it matters
Potential benefit: If successful, the approach could improve how symptoms and tolerated treatments are tracked in early-phase cancer trials and inform more patient-centered care.
How similar studies have gone: Previous cancer trials have explored wearables and ePROs, with growing evidence supporting feasibility in oncology settings, though this specific early-phase, single-arm pilot is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years at the time of enrollment * Access to a mobile phone running iOS (X or more recent) or Android 14 (or more recent) * Ability to connect their mobile phone with their existing or provided smartwatch * Ability to read and understand English * Referred to the Novel Therapeutics Clinic and enrolled in an early-phase clinical trial * Ability to demonstrate the use of a mobile device and application for electronic patient-reported outcome (ePRO) completion * Willingness to wear an actigraphy device for 4 weeks, at least 12 hours per day over four weeks. * Ability to provide informed consent. Exclusion Criteria: * Upper limb amputation, extensive tattoos, or lymphedema that may interfere with actigraphy data collection.
Where it's running
-
Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute
Cleveland, Ohio, United States Recruiting
Study contacts
- Principal investigator: Joel Saltzman, MD — Case Comprehensive Cancer Center, Cleveland Clinic
- Study coordinator: Joel Saltzman, MD
- Email: saltzmj@ccf.org
- Phone: 440-312-4569
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Robot-assisted bronchoscopy for peripheral lung lesions: comparing Monarch and ION platforms
Doctors are testing two FDA-cleared robotic bronchoscopy tools to see which more often successfully sample peripheral lung lesions during a bronchoscopy.
-
Safety and preliminary activity of BMS-986504 in unresectable MPNST
A new medicine called BMS-986504 is being tested to see if it is safe and may help people with unresectable malignant peripheral nerve sheath tumors, especially those whose tumors lack MTAP.
-
HPV DNA-guided chemoradiation with Retifanlimab for locally advanced anal cancer
This study tests whether adjusting chemoradiation doses based on HPV ctDNA results and adding Retifanlimab after CRT can improve outcomes for adults with new, locally advanced anal cancer.
-
MiraBurst to help with changes in taste from cancer treatment
This study tests whether freeze-dried miracle fruit (MiraBurst) can improve taste changes in adults with solid tumors who are undergoing cancer treatment.
-
Memory-avoidance whole brain radiotherapy: trying to protect memory while treating brain metastases
This study tests whether memory-avoidance whole brain radiotherapy with memantine is better at preserving thinking and memory than hippocampal-avoidance whole brain radiotherapy with memantine for adults with brain metastases.
-
Vitamin D and light therapy to boost skin cancer response before surgery
This study tests whether giving Vitamin D or a placebo around the time of a light-based treatment (PDT) can help boost skin cancer treatment before Mohs surgery or ED&C in adults with basal cell or squamous cell carcinoma.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.