COMPLETED

Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy

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

This phase IV trial compares patient satisfaction with telehealth versus in-person neuro-oncology assessments among glioma patients receiving oral chemotherapy. Gliomas are the most common primary central nervous system cancer and are associated with a high symptom burden, such as drowsiness, fatigue, memory difficulty, and difficulty communicating. Care at a high volume center is associated with an overall survival benefit, however, many patients may have physical or financial difficulties preventing access to these centers. Telehealth visits use computers, cameras, videoconferencing, the internet, satellite, and wireless communications to deliver healthcare, while in-person visits require the interaction to take place in the physical presence of someone else. Telehealth neuro-oncology assessments may be preferable compared to in-person assessments in glioma patients receiving oral chemotherapy.

Official Title

Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy

Quick Facts

Study Start:2024-10-07
Study Completion:2025-11-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06625047

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. * Age ≥ 18 years
  2. * Diagnosis of glioma requiring adjuvant chemotherapy. Patients with glioblastoma (GBM); astrocytoma, IDH-mutant; oligodendroglioma IDH-mutant, 1p/19q codeleted are eligible
  3. * Patients eligible to receive temozolomide as standard of care adjuvant therapy
  4. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60
  5. * Expected survival ≥ 6 months in the opinion of treatment team
  6. * Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations
  7. * Participants who do not have devices that will permit telehealth visits will be provided such tablet devices to facilitate appointments for the duration of the study
  8. * Participants who do not have financial resources to travel for in-person visits will be provided assistance for cost of travel
  9. * Ability to complete patient experience surveys by the participant with or without assistance from their caregiver
  1. * Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
  2. * Pregnant or nursing, imprisoned, or lacking capacity for understanding
  3. * Unable to swallow tablets or at risk for impaired absorption of oral medication
  4. * Known hypersensitivity or allergy to temozolomide

Contacts and Locations

Principal Investigator

Ugur T. Sener, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic
Tufia C. Haddad, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Ugur T. Sener, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic
  • Tufia C. Haddad, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

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 Date2024-10-07
Study Completion Date2025-11-12

Study Record Updates

Study Start Date2024-10-07
Study Completion Date2025-11-12

Terms related to this study

Additional Relevant MeSH Terms

  • Astrocytoma, IDH-Mutant
  • Glioblastoma
  • Glioma
  • Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted