A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chemotherapy, Computed Tomography, Internet-Based Intervention, Magnetic Resonance Imaging.
- Who it may be relevant to
- Registry conditions: Glioma, Recurrent Glioma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neuro-Oncology Anywhere: Glioma Home-Based Sequential Therapy (GHoST) Protocol
Overview
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.
Detailed 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 newly diagnosed or recurrent glioma, stratified by tumor type.
IV. Assess the safety and tolerability of remote chemotherapy management and patient monitoring among patients with glioma undergoing systemic therapy.
EXPLORATORY OBJECTIVES:
I. Assess the acceptance or satisfaction of patients with the remote monitoring in this trial and how these may differ between newly diagnosed and recurrent glioma.
II. Investigate PFS based on therapeutic sequence administered. III. Explore potential differences in compliance, adherence, and satisfaction measures and how they may correspond to health disparities and social determinants of health.
IV. Compare access to neuro-oncology care at Mayo Clinic among patients with low socioeconomic status assessed based on the Mayo Clinic Housing-Based Socioeconomic Status (HOUSES) Index during the two years following study activation compared to historical utilization data.
V. Compare access to neuro-oncology care at Mayo Clinic among patients with increased distance from academic centers assessed by geospatial index during the two years following study activation compared to historical utilization data.
OUTLINE:
Patients receive access to the remote chemotherapy management and patient monitoring platform to watch educational videos, report when medication is taken or missed, and report any symptoms related to cancer or medication side effects on study. Patients also receive standard of care chemotherapy as assigned by their treating physician as part of the platform on study. Upon completion of standard of care chemotherapy, if there is no disease progression, patients transition to surveillance for up to 1 year. Patients who experience disease progression during treatment or surveillance may rejoin the platform and/or be assigned by their treating physician to a different chemotherapy agent as part of the platform. Patients also undergo magnetic resonance imaging (MRI) or computed tomography (CT) throughout the study.
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
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)]
Secondary outcome measures (7)
- Acceptance of and satisfaction of patients with the remote monitoring [Time frame: Up to 3 years]
- Adherence to study therapeutics [Time frame: Up to 3 years]
- Feasibility of remote systemic therapy assessments [Time frame: Up to 3 years]
- Progression free survival (PFS) for each therapeutic treatment diagnosed and recurrent glioma [Time frame: At 6 months]
- Objective response rate [Time frame: Up to 3 years]
- Incidence of adverse events [Time frame: Up to 3 years]
- Safety of the overall platform [Time frame: Up to 3 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07074756 · MC240703 · NCI-2025-04495 · 24-009234 · MC240703