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

Summary

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.

Eligibility

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

  * Exception: Not required if patient is already on treatment. May be obtained prior to next treatment as needed per clinical care
* Provide written informed consent
* Ability to complete assessments and questionnaires by themselves or with assistance
* SUBSTUDY 1: Enrolled in GHoST Master Protocol per eligibility criteria of the master study and clinically appropriate to proceed with bevacizumab treatment at the discretion of the treating physician
* SUBSTUDY 1: Diagnosis of recurrent glioblastoma and intention to treat with bevacizumab

  * NOTE: Any number of prior recurrences is permitted
  * NOTE: Prior limited use of bevacizumab for radiation necrosis/treatment related edema is permitted. Prior use should not exceed four infusions with the last dose administered ≥ 4 weeks prior to enrollment in this substudy
* SUBSTUDY 1: Willing and able to adhere to the substudy for the duration of the substudy including undergoing treatment, and attending scheduled visits, and examinations
* SUBSTUDY 1: Negative pregnancy test ≤ 8 days prior to registration for persons of childbearing potential only
* SUBSTUDY 1: Provide written informed consent
* SUBSTUDY 1: 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
* SUBSTUDY 1: Pregnant or nursing, imprisoned, or lacking capacity for understanding
* SUBSTUDY 1: Uncontrolled and/or intercurrent illness or other condition which limits safety of or compliance with study proceedings

Conditions4

Interventions3

Locations2 sites

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