Astrocytoma, IDH-MutantPhase 4NCT06625047
Comparing Telehealth and In-person Assessments in Glioma Patients Receiving Oral Chemotherapy
A Phase 4 study testing Assessment, Questionnaire Administration and Telemedicine Visit in people with Astrocytoma, IDH-Mutant and Glioblastoma, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Astrocytoma, IDH-Mutant, Glioblastoma, Glioma
- What is being tested?
- Assessment, Questionnaire Administration and Telemedicine Visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2024to 12 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy
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.
Read the detailed description
PRIMARY OBJECTIVE:
- Assess patient satisfaction with care delivered as measured by institutional Press-Ganey survey scores obtained following telehealth and in-person assessments.
SECONDARY OBJECTIVES:
- 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.
- 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
- Being tested
- Assessment, Questionnaire Administration, Telemedicine Visit, Temozolomide
- Medical subject headings
- Astrocytoma, Glioblastoma, Glioma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AssessmentBehavioural
Also called Assess, Study Assessment, Study Observation
Complete in-person assessment visits
Questionnaire AdministrationOther
Ancillary studies
Telemedicine VisitOther
Also called Telemedicine Encounter
Complete telehealth assessment visits
TemozolomideDrug
Also called CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831
Given PO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Assessment; Other: Questionnaire Administration; Other: Telemedicine Visit; Drug: Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (5)
Completion rate of planned oral chemotherapy
The proportion of doses planned for a cycle that are completed for the telehealth vs. the in-person cycles for patients will be evaluated. The average completion rates for telehealth vs. in-person assessment cycles will be evaluated and compared across patients.
Measured: Within 28 days of telehealth or in-person visits and up to 6 months
Preference for telehealth vs. in-person neuro-oncologic evaluations
Preference will be assessed using the Visit Modality Preference Assessment, a single question with multiple choice answer (in-person visit, virtual visit, or no preference). These will be summarized both graphically and quantitatively and compared between the treatment groups.
Measured: Up to 6 months
Acute care utilization days
Emergency department visits and days of hospitalization compared between telehealth visits and in-person visits will be summarized both graphically and quantitatively.
Measured: Within 28 days of telehealth or in-person visits, up to 6 months
Neurologic impairment - NANO
Neurologic impairment will be measured by the Neurologic Assessment in Neuro-Oncology (NANO) scale 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. he NANO scale is a quick, office-based assessment that evaluates eight neurologic domains, including Gait, Strength, Upper extremity ataxia, Sensation, Visual fields, Facial strength, Language, and Level of consciousness.
Measured: Up to 6 months
Change in quality of life - EORTC QLQ-C30
Quality of life measures will be obtained using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30) at baseline (enrollment) and following each chemotherapy cycle (28 days). The EORTC QLQ-C30 consists of three sections: functioning (15questions), symptom (13 questions), and global health status (2questions). The higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start7 Oct 2024
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Astrocytoma, IDH-MutantStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ugur T. Sener, MD, Principal investigator, Mayo ClinicTufia C. Haddad, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625047
- Sponsor's protocol ID
- NOA242
- Other IDs
- NOA242, 24-007538
- Status last verified
- Dec 2025
- First submitted
- 1 Oct 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41567708
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuro-Oncology Anywhere 242: Pilot Study Evaluating Telehealth and In-Person Assessments in Patients With Glioma Receiving Oral Chemotherapy
- ClinicalTrials.gov ID
- NCT06625047
- Acronym / sponsor ID
- NOA242
- Conditions
- Astrocytoma, IDH-Mutant, Glioblastoma, Glioma, Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 7 Oct 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess patient satisfaction with care delivered as measured by institutional Press-Ganey survey scores obtained following telehealth and in-person assessments.
SECONDARY OBJECTIVES:
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (temozolomide, telehealth, in-person) | Experimental | Behavioral: Assessment, Other: Questionnaire Administration, Other: Telemedicine Visit, Drug: TemozolomidePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AssessmentAlso: Assess, Study Assessment, Study ObservationComplete in-person assessment visits | Behavioural | Health services research (temozolomide, telehealth, in-person) |
| Questionnaire AdministrationAncillary studies | Other | Health services research (temozolomide, telehealth, in-person) |
| Telemedicine VisitAlso: Telemedicine EncounterComplete telehealth assessment visits | Other | Health services research (temozolomide, telehealth, in-person) |
| TemozolomideAlso: CCRG-81045, Gliotem, Imidazo[5,1-d]-1,2,3,5-tetrazine-8-carboxamide, 3, 4-dihydro-3-methyl-4-oxo-, M & B 39831Given PO | Drug | Health services research (temozolomide, telehealth, in-person) |
Primary outcome
Patient satisfaction with care delivered
Time frame: Up to 6 months
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.
5 secondary outcomes
Completion rate of planned oral chemotherapy
Time frame: Within 28 days of telehealth or in-person visits and up to 6 months
Preference for telehealth vs. in-person neuro-oncologic evaluations
Time frame: Up to 6 months
Acute care utilization days
Time frame: Within 28 days of telehealth or in-person visits, up to 6 months
Neurologic impairment - NANO
Time frame: Up to 6 months
Change in quality of life - EORTC QLQ-C30
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Derived from this study: PubMed 41567708Sener 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ugur T. Sener, MD principal investigator
Mayo Clinic
Tufia C. Haddad, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Assessment, Questionnaire Administration and Telemedicine Visit in people with Astrocytoma, IDH-Mutant and Glioblastoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction with care delivered (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06625047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.