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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07074756
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chemotherapy — DRUG
    Receive standard of care chemotherapy
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Internet-Based Intervention — OTHER
    Receive access to the remote chemotherapy management and patient monitoring platform
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Neurologic Examination — PROCEDURE
    Ancillary studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Surveillance — BEHAVIORAL
    Undergo surveillance

Study Details

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.

Key Dates

Start date
Sep 12, 2025
Status verified
Mar 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Ugur T. Sener, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Ugur T. Sener, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

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