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

NCT06625047 | Completed Phase 4

• 2 other identifiers: NOA24224-007538
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction with care delivered

  Satisfaction will be measured using Press-Ganey survey scores. Scores following each cycle of chemotherapy will be compared between alternating telehealth and in-person visits. The mean score associated with the telehealth visits versus (vs.) the in-person visits will be calculated for each patient. Potential patterns of changes associated with these scores over time will be graphically evaluated. Repeated measures mixed effects models will be used to further evaluate potential influence of a time element with the satisfaction scores for telehealth vs. in-person assessments.

  Up to 6 months

Secondary Outcomes (5)

• Completion rate of planned oral chemotherapy

  Within 28 days of telehealth or in-person visits and up to 6 months

• Preference for telehealth vs. in-person neuro-oncologic evaluations

  Up to 6 months

• Acute care utilization days

  Within 28 days of telehealth or in-person visits, up to 6 months

• Neurologic impairment - NANO

  Up to 6 months

• Change in quality of life - EORTC QLQ-C30

  Up to 6 months

Study Arms (1)

Health services research (temozolomide, telehealth, in-person)

EXPERIMENTAL

Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles while on study in the absence of disease progression or unacceptable toxicity. Patients complete alternating telehealth assessment visits and in-person assessment visits after each cycle of treatment.

Behavioral: Assessment; Other: Questionnaire Administration; Other: Telemedicine Visit; Drug: Temozolomide

Interventions

Assessment BEHAVIORAL

Complete in-person assessment visits

Also known as: Assess, Study Assessment, Study Observation

Health services research (temozolomide, telehealth, in-person)

Questionnaire Administration OTHER

Ancillary studies

Health services research (temozolomide, telehealth, in-person)

Telemedicine Visit OTHER

Complete telehealth assessment visits

Also known as: Telemedicine Encounter

Health services research (temozolomide, telehealth, in-person)

Temozolomide DRUG

Given PO

Also known as: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831, M and B 39831, Methazolastone, RP-46161, SCH 52365, Temcad, Temizole, Temodal, Temodar, Temomedac, TMZ

Health services research (temozolomide, telehealth, in-person)

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years
• Diagnosis of glioma requiring adjuvant chemotherapy. Patients with glioblastoma (GBM); astrocytoma, IDH-mutant; oligodendroglioma IDH-mutant, 1p/19q codeleted are eligible
• Patients eligible to receive temozolomide as standard of care adjuvant therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, AND Karnofsky performance status (KPS) of ≥ 60
• Expected survival ≥ 6 months in the opinion of treatment team
• Willing and able to adhere with the protocol for the duration of the study including undergoing treatment, and attending scheduled visits, and examinations
• 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
• Participants who do not have financial resources to travel for in-person visits will be provided assistance for cost of travel
• Ability to complete patient experience surveys by the participant with or without assistance from their caregiver

You may not qualify if:

• Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
• Pregnant or nursing, imprisoned, or lacking capacity for understanding
• Unable to swallow tablets or at risk for impaired absorption of oral medication
• Known hypersensitivity or allergy to temozolomide

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Sener U, Galloway T, Neth B, Uhm J, Kizilbash SH, Campian JL, Caron S, Breen WG, Lehrer E, Golembiewski E, Schultz S, Hughes H, Steinmetz S, Geyer S, Mead-Harvey C, Huebert C, Tauer W, Mason C, Burns TC, Pritchett J, Haddad T. Protocol for neuro-oncology anywhere 242: Pilot study evaluating telehealth and in-person assessments in patients with glioma receiving oral chemotherapy. Contemp Clin Trials Commun. 2025 Dec 23;49:101593. doi: 10.1016/j.conctc.2025.101593. eCollection 2026 Feb.

  PMID: 41567708 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Astrocytoma; Glioblastoma; Glioma; Oligodendroglioma

Interventions

Restraint, Physical; Outcome Assessment, Health Care; Observational Studies as Topic; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Evaluation Mechanisms; Health Care Quality, Access, and Evaluation; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Public Health; Environment and Public Health; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ugur T. Sener, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Tufia C. Haddad, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: October 7, 2024
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: April 29, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)