A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma

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A Digital Treatment Platform for the Delivery of Home-Based Sequential Therapy in Patients With Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07074756
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Mayo Clinic
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Ugur T. Sener, MD
Principal Investigator Affiliation	Mayo Clinic in Rochester
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Recurrent Glioma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic in Rochester, Rochester 5043473, Minnesota 5037779

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Address

Mayo Clinic in Rochester

Rochester 5043473, Minnesota 5037779, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015