RECRUITING

Glioblastoma Remote Monitoring and Care - Research Protocol

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Conditions

GlioblastomaVenous ThromboembolismSeizures

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Glioblastoma Remote Monitoring and Care - Research Protocol

Quick Facts

Study Start:2024-04-30
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06129760

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * newly-diagnosed or recurrent glioblastoma undergoing treatment or active surveillance
  2. * at least 18 years of age at the time of study enrolment
  3. * Karnofsky Performance Status (KPS) ≥ 70% at time of study enrolment
  4. * able to comprehend informed consent form and provide informed consent
  5. * access to patient or caregiver's own Apple iPhone to interface with watch application for documentation of symptoms
  1. * under 18 years of age at the time of study enrolment
  2. * inability to give informed consent due to aphasia or other language barrier
  3. * 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
  4. * inability to tolerate Apple Watch for at least 12 hours per day on at least 50% of days in a four-week period
  5. * no access to patient or caregiver Apple iPhone to document symptoms

Contacts and Locations

Study Contact

Andrew Dhawan, MD, DPhil
CONTACT
216-444-4272
dhawana@ccf.org

Principal Investigator

Andrew Dhawan, MD, DPhil
PRINCIPAL_INVESTIGATOR
Brain Tumor Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
Rowan Barker-Clarke, PhD
PRINCIPAL_INVESTIGATOR
Lerner Research Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
Siamrut Patanavanich
PRINCIPAL_INVESTIGATOR
Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Study Locations (Sites)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Andrew Dhawan, MD, DPhil, PRINCIPAL_INVESTIGATOR, Brain Tumor Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
  • Rowan Barker-Clarke, PhD, PRINCIPAL_INVESTIGATOR, Lerner Research Institute, Cleveland Clinic Foundation, Case Comprehensive Cancer Center
  • Siamrut Patanavanich, PRINCIPAL_INVESTIGATOR, Cleveland Clinic Foundation, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-30
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2024-04-30
Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Glioblastoma
  • Venous Thromboembolism
  • Seizures