IRB Study Number 23-1286
Status Recruiting
Institute Taussig Cancer Institute
Description
2.1 Primary Objectives
- To determine the feasibility of wearing the Apple watch for at least 16 hours per day in patients with
glioblastoma.
- To determine the feasibility of consistently documenting notable symptoms in the associated iPhone application
(GBMStudy), in patients with glioblastoma and/or their caretakers.
2.2 Exploratory Objectives
- To identify actigraphy variables that are predictive of clinical symptoms, major health outcomes (e.g. tumor
progression, VTE, major cardiac events), and clinical covariates (e.g. tumor location, volume, and KPS).
- To identify optimal compression and resampling times for actigraphy data in predicting clinical symptoms,
clinical covariates, and major health outcomes.
Inclusion Criteria
• newly-diagnosed or recurrent glioblastoma undergoing treatment or active surveillance
• at least 18 years of age at the time of study enrolment
• Karnofsky Performance Status (KPS) ≥ 70% at time of study enrolment
• able to comprehend informed consent form and provide informed consent
• access to patient or caregiver’s own Apple iPhone to interface with watch application for documentation of symptoms
Exclusion Criteria
• under 18 years of age at the time of study enrolment
• inability to give informed consent due to aphasia or other language barrier
• tattoos located on the skin of the wrist or forearm where the Apple Watch will be placed or other skin conditions preventing adequate sensor function
• inability to tolerate Apple Watch for at least 12 hours per day on at least 50% of days in a four-week period
• no access to patient or caregiver Apple iPhone to document symptoms
