Actively Recruiting
Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
Led by Mayo Clinic · Updated on 2026-03-27
120
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a digital treatment platform called Glioma Home-Based Sequential Therapy (GHoST) for patients with glioma undergoing systemic therapy. This study addresses the critical shortage of specialized neuro-oncology care in the United States by providing continuous remote access to care teams, aiming to improve trial participation and develop new treatments while reducing health disparities. The study assesses feasibility, patient adherence, safety, and treatment outcomes for newly diagnosed or recurrent glioma patients. Participants receive access to the remote chemotherapy management and patient monitoring platform, which includes educational videos, medication adherence tracking, and symptom reporting related to cancer and side effects. Patients continue standard chemotherapy assigned by their doctors and undergo MRI or CT scans as part of the study. After chemotherapy completion without disease progression, patients enter surveillance for up to one year, and those with progression may rejoin the platform or change chemotherapy agents as directed by their physicians. Throughout the study, participants complete assessments and questionnaires either independently or with help. Researchers monitor treatment adherence, safety, progression-free survival, and objective response rates, along with patient satisfaction with remote monitoring. The study includes regular imaging and neurologic exams, with observation lasting up to three years. The primary outcome is the feasibility of completing study visits over six months, with additional safety and efficacy outcomes assessed for up to three years.
CONDITIONS
Brief Title
A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of glioma with new or ongoing systemic therapy planned for at least 6 months
- May enroll after surgery and/or radiation therapy for newly diagnosed or recurrent tumor
- Any number of prior tumor recurrences allowed
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Karnofsky performance status (KPS) of 60 or higher
- Expected survival of at least 6 months as judged by treatment team
- Willingness and ability to follow study procedures including treatment and scheduled visits
- Negative pregnancy test within 8 days before registration for persons who can become pregnant
- Ability to complete assessments and questionnaires independently or with help
- Provide written informed consent
You will not qualify if you...
- Pregnant or nursing
- Prisoner or lacking capacity to understand the study
- Uncontrolled or concurrent illness or condition limiting safety or study compliance
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At least 6 months
Participants receive standard of care chemotherapy monitored remotely through a digital platform, reporting medication adherence and symptoms related to cancer or medication side effects.
Baseline and study-specific visits through approximately 6 months (26 weeks ± 2 weeks)
Duration - Up to 1 year
Participants who complete chemotherapy without disease progression transition to surveillance for up to 1 year, with ongoing monitoring including MRI or CT scans.
Visits for imaging and monitoring throughout surveillance
Trial Site Locations
Total: 2 locations
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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