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

NCT ID: NCT06625047

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2025-11-12

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.

Detailed Description

PRIMARY OBJECTIVE:

I. Assess patient satisfaction with care delivered as measured by institutional Press-Ganey survey scores obtained following telehealth and in-person assessments.

SECONDARY OBJECTIVES:

I. Assess completion rate of planned oral chemotherapy among patients with glioma within 28 days of telehealth visits compared to within 28 days of in-person visits.

II. Assess preference for telehealth versus in-person neuro-oncologic evaluations among patients with glioma receiving oral chemotherapy.

III. Assess acute care utilization days, defined as emergency department evaluations and days of hospitalization within 28 days of telehealth visits compared to within 28 days of in-person visits.

IV. Assess neurologic impairment as measured by the Neurologic Assessment in Neuro-Oncology (NANO) scale will be measured at each visit with rate of neurological decline within the 28 days following telehealth assessments compared to neurological decline within the 28 days following in-person assessments.

V. Assess quality of life as measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30), a 30-item questionnaire that is used to assess the quality of life of cancer patients, completed at baseline and at the end of each chemotherapy cycle.

OUTLINE:

Patients receive temozolomide orally (PO) once daily (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.

After completion of study intervention, patients are followed up at 30 days.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

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.

Group Type: EXPERIMENTAL

Assessment

Intervention Type: BEHAVIORAL

Complete in-person assessment visits

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Telemedicine Visit

Intervention Type: OTHER

Complete telehealth assessment visits

Temozolomide

Intervention Type: DRUG

Given PO

Interventions

Assessment

Complete in-person assessment visits

Intervention Type: BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Telemedicine Visit

Complete telehealth assessment visits

Intervention Type: OTHER

Temozolomide

Given PO

Intervention Type: DRUG

Other Intervention Names

Assess; Study Assessment; Study Observation; Telemedicine Encounter; 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

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ugur T. Sener, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Tufia C. Haddad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

NCI-2024-07700

Identifier Type: REGISTRY

Identifier Source: secondary_id

NOA242

Identifier Type: OTHER

Identifier Source: secondary_id

24-007538

Identifier Type: OTHER

Identifier Source: secondary_id

NOA242

Identifier Type: -

Identifier Source: org_study_id