Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
Mayo Clinic
Summary
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.
Description
PRIMARY OBJECTIVE: I. Determine the feasibility of the remote chemotherapy management and patient monitoring platform glioma home-based sequential therapy (GHoST) protocol among patients with glioma undergoing systemic therapy. SECONDARY OBJECTIVES: I. Evaluate compliance, adherence, and feasibility in terms of the adherence to systemic therapy monitored remotely. II. Determine progression free survival (PFS) for each therapeutic evaluated for newly diagnosed or recurrent glioma, stratified by tumor type. III. Determine objective response rate (ORR) for each therapeutic evaluated for newl…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 stu…
Interventions
- DrugChemotherapy
Receive standard of care chemotherapy
- ProcedureComputed Tomography
Undergo CT
- OtherInternet-Based Intervention
Receive access to the remote chemotherapy management and patient monitoring platform
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedureNeurologic Examination
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
- BehavioralSurveillance
Locations (2)
- Mayo Clinic in FloridaJacksonville, Florida
- Mayo Clinic in RochesterRochester, Minnesota