Clinical trial · Interventional
Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy
Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, IDH-Mutant | Astrocytoma, IDH-Mutant | ONTOLOGY_EXACT | 0.90 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
| Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted | Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assessment | Behavioral | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Telemedicine Visit | Other | — | UNRESOLVED |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Health services research (temozolomide, telehealth, in-person)
- description
- 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.
- interventionNames
- Behavioral: Assessment
- Other: Questionnaire Administration
- Other: Telemedicine Visit
- Drug: Temozolomide
Primary outcomes (1)
- measure
- Patient satisfaction with care delivered
- timeFrame
- Up to 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSener 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