Glioblastoma Remote Monitoring and Care - Research Protocol

NCT06129760 | Suspended DMC

• 1 other identifier: CASE4323
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to learn more about how what the Apple watch measures, in terms of walking data, heart rate, breathing rate, and sleep habits, relates to how participants feel. During the course of the treatment, the symptoms participants experience change, and whether the Apple watch can detect these changes. Ultimately, this knowledge is being used to design proactive tools and signatures that can predict complications or symptom changes before they happen.

Conditions

Glioblastoma; Venous Thromboembolism; Seizures

Outcome Measures

Primary Outcomes (2)

• Success rate of 16-hour wear-time

  The wear time will be defined by the "wear detection" onboard the Apple Watch. Median value per day will be used to avoid biasing this estimate toward outlier days. A 16-hr wear-time requirement will be considered feasible for studies of the GBM patient population if results show that there is a greater than 90% likelihood (within the 90% confidence interval) that a member of the population.

  6 months

• Symptom collection success rate

  Symptom collection success in a specific patient will be defined as the patient reporting at least one symptom in ≥ 90% of their weeks (22 or more in 6 months) enrolled.

  6 months

Study Arms (1)

Wearing the Apple watch and the associated logging of health data

EXPERIMENTAL

As part of the monitoring needed for this study, participants will be enrolled for at least 6 months, as this will give enough data to understand how the participant's health changes associate with what is measured by the Apple watch. After this 6 month period, participants may choose to end their participation on the study, or continue if they wish.

Device: Apple Watch

Interventions

Apple Watch DEVICE

The wearable sensor device is the Apple Watch Series 6 or newer

Wearing the Apple watch and the associated logging of health data

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Glioblastoma; Venous Thromboembolism; Seizures

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Dhawan, MD, DPhil

  Brain Tumor Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Rowan Barker-Clarke, PhD

  Lerner Research Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

• Siamrut Patanavanich

  Cleveland Clinic Foundation, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, prospective, unblinded cohort study to establish feasibility that will provide the basis for larger prospective studies using wearables. The results from this study will be used to refine the actigraphy signatures and analysis pipelines to be used in future prospective studies that will proactively identify health changes in participants with glioblastoma.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 13, 2023
• Study Start: April 30, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Time frame will be at time of publication of primary endpoints or 2 years post-trial completion, whichever is sooner
• Access Criteria: Any qualified investigator by way of formal request to the corresponding PI of the study

Locations

US (1)