A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma
NCT ID: NCT07074756
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-09-12
2028-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Supportive Care (remote chemotherapy management)
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 MRI or CT throughout the study.
Chemotherapy
Receive standard of care chemotherapy
Computed Tomography
Undergo CT
Internet-Based Intervention
Receive access to the remote chemotherapy management and patient monitoring platform
Magnetic Resonance Imaging
Undergo MRI
Neurologic Examination
Ancillary studies
Questionnaire Administration
Ancillary studies
Surveillance
Undergo surveillance
Interventions
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Chemotherapy
Receive standard of care chemotherapy
Computed Tomography
Undergo CT
Internet-Based Intervention
Receive access to the remote chemotherapy management and patient monitoring platform
Magnetic Resonance Imaging
Undergo MRI
Neurologic Examination
Ancillary studies
Questionnaire Administration
Ancillary studies
Surveillance
Undergo surveillance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Ugur T. Sener, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Clinical Trials Referral Office
Role: primary
Related Links
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Related Info
Other Identifiers
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NCI-2025-04495
Identifier Type: REGISTRY
Identifier Source: secondary_id
24-009234
Identifier Type: OTHER
Identifier Source: secondary_id
MC240703
Identifier Type: OTHER
Identifier Source: secondary_id
MC240703
Identifier Type: -
Identifier Source: org_study_id