NCT07074756 · Mayo Clinic
A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma
What this study is about
This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient.
View original scientific description
This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while addressing a great health disparity in patients with glioma.
Interventions
DRUG
Chemotherapy
Receive standard of care chemotherapy
PROCEDURE
Computed Tomography
Undergo CT
OTHER
Internet-Based Intervention
Receive access to the remote chemotherapy management and patient monitoring platform
PROCEDURE
Magnetic Resonance Imaging
Undergo MRI
PROCEDURE
Neurologic Examination
Ancillary studies
OTHER
Questionnaire Administration
Ancillary studies
BEHAVIORAL
Surveillance
Undergo surveillance
DRUG
Propranolol
Given PO
DRUG
Imipramine
Given PO
DRUG
Bevacizumab
Given IV
Primary outcome measures
Feasibility - completion of study visits
Time frame: At baseline and the set of study-specific visits through 6 months (i.e., 26 weeks ± 2 weeks)
Feasibility will be assessed by the number of study visits completed vs. not. Will consider this to be feasible in this patient population if the true compliance rate is at least 60%. Compliance here is defined as completion of at least 4 disease assessment timepoints in the first 6 months on study (i.e. 26 ± 2 weeks). These assessment timepoints will include the baseline assessment and can include assessments after 2 cycles of therapy, after 4 cycles of therapy, after 6 cycles of therapy, dependent on the treatment-specific schedules.
4-month progression-free survival (PFS) rate (Subprotocol 1)
Time frame: Up to 4 months after beginning study therapy
Defined as the number of patients who are alive and progression-free at least 4 months after beginning study therapy. A point estimate will be generated for 4-month PFS rate.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age ≥ 18 years
- Diagnosis of glioma and intention to treat with either new or ongoing systemic therapy for at least 6 months.
- NOTE: Patient may be enrolled following completion of surgery and/or radiation therapy for newly diagnosed or recurrent tumor.
- NOTE: Any number of prior recurrences is permitted
- 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
- Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
- Provide written informed consent
- Ability to complete assessments and questionnaires by themselves or with assistance
Exclusion criteria
- Pregnant or nursing, imprisoned, or lacking capacity for understanding
- Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
Where
- Jacksonville, Florida
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 10, 2026 · Source of record for eligibility and locations