Home-based digital platform delivering sequential therapy for people with glioma
Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
This program will test a mobile app that helps deliver and remotely monitor home-based systemic therapy for adults with newly diagnosed or recurrent glioma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT07074756 on ClinicalTrials.gov |
What this trial studies
The GHoST platform uses a mobile application to deliver and remotely monitor sequential systemic therapies for adults with newly diagnosed or recurrent glioma. Patients receive treatment at home while clinicians track adherence, symptoms, and safety data through the platform alongside scheduled imaging and neurologic exams. The primary goal is to determine feasibility of remote chemotherapy management, with secondary endpoints including adherence, progression-free survival, objective response rate, and safety. Exploratory analyses will measure patient satisfaction and examine how adherence and access differ by socioeconomic factors.
Who should consider this trial
Good fit: Adults aged 18 or older with newly diagnosed or recurrent glioma planning at least six months of systemic therapy, with ECOG performance status 0–2 (KPS ≥60) and an expected survival of six months or more, are the ideal candidates.
Not a fit: Patients who are pregnant or nursing, incarcerated, lack capacity for informed consent, cannot use or access the digital platform, or who have very limited life expectancy or poor functional status are unlikely to benefit.
Why it matters
Potential benefit: If successful, the platform could expand access to neuro-oncology specialists, enable more patients to receive and monitor systemic therapy at home, and increase participation in clinical research.
How similar studies have performed: Telemedicine and remote monitoring have improved oncology care delivery and trial participation in other cancers, but applying a dedicated home-based sequential chemotherapy platform specifically for glioma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jacksonville, Florida and 1 other locations
- Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Ugur T. Sener, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.