← Back to Search

Chemotherapy

Telehealth vs In-Person Assessments for Brain Tumors

Phase 4

Recruiting

Led By Ugur T. Sener, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients eligible to receive temozolomide as standard of care adjuvant therapy

Diagnosis of glioma requiring adjuvant chemotherapy. Patients with glioblastoma (GBM); astrocytoma, IDH-mutant; oligodendroglioma IDH-mutant, 1p/19q codeleted are eligible

Must not have

Pregnant or nursing, imprisoned, or lacking capacity for understanding

Unable to swallow tablets or at risk for impaired absorption of oral medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

"This trial compares how satisfied brain cancer patients are with either virtual or in-person appointments for assessing their condition while on oral chemotherapy. Brain cancer patients often experience symptoms like tiredness, memory issues, and difficulty

Who is the study for?

This trial is for glioma patients undergoing oral chemotherapy who may benefit from telehealth assessments. Ideal participants are those with brain tumors like glioblastoma, oligodendroglioma, or astrocytoma and experience high symptom burden.

What is being tested?

The study compares patient satisfaction between telehealth (using technology for remote care) and traditional in-person medical assessments among glioma patients on oral chemotherapy.

What are the potential side effects?

While the trial itself doesn't involve medication side effects, Temozolomide used in treatment can cause tiredness, nausea, constipation, headache and dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for temozolomide as part of my standard treatment.

Select...

I have a glioma and need additional chemotherapy.

Select...

I am 18 years old or older.

Select...

I can care for myself and am up more than 50% of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant, nursing, imprisoned, or unable to understand my medical care.

Select...

I cannot swallow pills or have issues absorbing medication taken by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Patient satisfaction with care delivered

Secondary study objectives

Acute care utilization days

Change in quality of life - EORTC QLQ-C30

Completion rate of planned oral chemotherapy

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Health services research (temozolomide, telehealth, in-person)Experimental Treatment4 Interventions

Patients receive temozolomide PO QD on days 1-5 of each cycle. Cycles repeat every 28 days for up to 6 cycles per standard of care 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temozolomide

2010

Completed Phase 3

~1880

Assessment

2007

N/A

~2190