Health Trials

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

ConditionsGliomaRecurrent GliomaRecurrent Glioblastoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Chemotherapy

    Drug

    Receive standard of care chemotherapy

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Internet-Based Intervention

    Other intervention

    Receive access to the remote chemotherapy management and patient monitoring platform

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Neurologic Examination

    Procedure/Surgery

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Surveillance

    Behavioral

    Undergo surveillance

  • Propranolol

    Drug

    Given PO

  • Imipramine

    Drug

    Given PO

  • Bevacizumab

    Drug

    Given IV

Treatment groups

202 Participants
are divided into 3 treatment groups
Group A: GHoST Master Protocol (remote chemotherapy management)Experimental treatment 7 interventions
Group B: Subprotocol 1 Group A (propranolol, bevacizumab)Experimental treatment 6 interventions
Group C: Subprotocol 1 Group B (imipramine, bevacizumab)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Feasibility - completion of study visits

Feasibility will be assessed by the number of study visits completed vs. not. Will consider this to be feasible in this patient population if the true compliance rate is at least 60%. Compliance here is defined as completion of at least 4 disease assessment timepoints in the first 6 months on study (i.e. 26 ± 2 weeks). These assessment timepoints will include the baseline assessment and can include assessments after 2 cycles of therapy, after 4 cycles of therapy, after 6 cycles of therapy, dependent on the treatment-specific schedules.

Time frame
At baseline and the set of study-specific visits through 6 months (i.e., 26 weeks ± 2 weeks)
2

4-month progression-free survival (PFS) rate (Subprotocol 1)

Defined as the number of patients who are alive and progression-free at least 4 months after beginning study therapy. A point estimate will be generated for 4-month PFS rate.

Time frame
Up to 4 months after beginning study therapy

Secondary outcomes

1

Acceptance of and satisfaction of patients with the remote monitoring

Will be assessed with an electronic Assessment of Acceptance and Satisfaction survey sent to participants at study assessment timepoints. The satisfaction survey consists of a single question answered on a 5-point scale: very positive, somewhat positive, neutral, somewhat negative, very negative.

Time frame
Up to 3 years
2

Adherence to study therapeutics

Will be assessed through remote monitoring application. Here, adherence is defined as taking at least 80% of the prescribed doses, for all therapies other than lomustine. For lomustine, adherence is defined as receiving all prescribed infusions.

Time frame
Up to 3 years
3

Feasibility of remote systemic therapy assessments

Will be assessed through completion of visits as scheduled, where laboratory and imaging assessed for the visits are scheduled and completed prior to telehealth visits. Feasibility will be defined as having necessary pre-visit testing completed and delivered for clinician review prior to the visit as well as completion of the visit at the intended scheduled time for 60% of the visits.

Time frame
Up to 3 years
4

Progression free survival (PFS) for each therapeutic treatment diagnosed and recurrent glioma

Will be assessed for each treatment evaluated. PFS is defined as the time from enrollment to disease progression or death, whichever occurs first.

Time frame
At 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
Apply now