Digital Treatment Platform for Brain Tumor

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Pregnant, Nursing, Imprisoned, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital treatment platform designed to help manage care for individuals with glioma, a type of brain tumor. The platform uses a mobile app to deliver home-based therapy, enabling patients to report symptoms and communicate with their care team remotely. It aims to improve access to specialized care, potentially leading to better survival outcomes. This trial suits individuals diagnosed with glioma who are receiving or planning to receive ongoing chemotherapy for at least six months. As an unphased trial, it provides patients the opportunity to access innovative care solutions that could enhance their treatment experience.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems you can continue your existing treatment as long as it aligns with the trial's requirements.

What prior data suggests that this digital treatment platform is safe for patients with glioma?

Research has shown that digital health tools can significantly enhance care and quality of life for brain tumor patients. These tools enable patients to connect with their healthcare team from home, which is particularly beneficial for those who find traveling difficult.

While specific safety data for the digital platform used in this trial is unavailable, similar platforms have been safely used in other health areas. This suggests that this platform is likely safe and user-friendly. Patients can use it to watch educational videos, report medication use, and share any symptoms.

Overall, digital health tools are considered safe and can be very helpful in managing care remotely. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Treatment Platform for brain tumors because it offers a fresh approach to managing chemotherapy remotely. Unlike traditional treatments that require frequent hospital visits, this platform allows patients to watch educational videos, report medication adherence, and track symptoms from the comfort of their homes. This digital method not only supports standard chemotherapy care but also facilitates ongoing monitoring and adjustment of treatment plans based on real-time data, potentially improving patient outcomes and quality of life.

What evidence suggests that this digital treatment platform is effective for glioma?

Research has shown that digital health tools can greatly enhance care and quality of life for patients with brain tumors. Studies have found that these tools improve access to specialized brain tumor care, which is linked to better survival rates. Digital platforms assist patients who face challenges traveling to treatment centers due to distance or disability. Additionally, artificial intelligence in brain tumor care has shown promise in accurately identifying tumor details. In this trial, participants will access a digital treatment platform for remote chemotherapy management and patient monitoring, aiming to provide ongoing support and potentially improve care and outcomes for patients with glioma. ^{2 6 7 8 9}

Who Is on the Research Team?

Ugur T. Sener, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

This trial is for adults over 18 with glioma who can consent, survive at least 6 months, follow the study protocol, and are not pregnant or nursing. They should have completed any surgery/radiation and be on systemic therapy for at least 6 months. Any number of recurrences allowed; must have ECOG status of 0-2 and KPS ≥60.

Inclusion Criteria

Provide written informed consent

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

Exclusion Criteria

I am not pregnant, nursing, imprisoned, and I understand the study requirements.

I do not have any health conditions that would make it unsafe for me to participate in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care chemotherapy and use a digital platform for remote management and monitoring

6 months

Baseline and multiple assessment timepoints

Surveillance

Participants transition to surveillance if no disease progression occurs, monitored for up to 1 year

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Digital Treatment Platform

Trial Overview The trial tests a digital platform delivered via a mobile app that provides home-based sequential therapy to glioma patients. It aims to improve access to neuro-oncology specialists and potentially increase survival by allowing continuous care team contact.

How Is the Trial Designed?

Group I: Supportive Care (remote chemotherapy management) Experimental Treatment 7 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40408266/

Co-Designing a User-Centered Digital Health Tool for ... Digital health tools hold tremendous potential to enhance supportive care and quality of life for patients with brain tumors and their ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT07074756

A Digital Treatment Platform for the Delivery of ... - Clinical Trial Finder Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease- ...

3. nature.com nature.com/articles/s41698-024-00575-0

Artificial intelligence in neuro-oncology: advances and ... This review delves into the most recent advancements in applying artificial intelligence (AI) within neuro-oncology, specifically emphasizing work on gliomas.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2949761224000038

A Systematic Review and Meta-Analysis of Brain Tumors ... The study found that the best algorithms had a pooled lesion-wise Dice score of 84%, with pooled sensitivities of 87% (patient-wise) and 86% ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10946492/

Evaluation of the telehealth making sense of brain tumor ... Tele‐MAST was found to be more effective for reducing depressive symptoms at post‐intervention than standard care for people with PBT but not caregivers.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12124322/

Co-Designing a User-Centered Digital Health Tool for ... Digital health tools hold tremendous potential to enhance supportive care and quality of life for patients with brain tumors and their ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949829525001044

Advances in bridging computational and clinical outcomes ... The use of AI in CADD has accelerated the drug discovery process for the treatment of brain tumours within a significantly shorter time and cost compared to ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39949847/

Development of an evidence-informed implementation ... We explored the best way to introduce a digital supportive care platform to patients with a brain tumour, their carers and healthcare ...

9. mayoclinic.org mayoclinic.org/medical-professionals/neurology-neurosurgery/news/innovation-drives-brain-tumor-treatment/mac-20570354

Innovation drives brain tumor treatment Mayo Clinic applies the latest technical advancements to maximize the safety and outcomes of brain tumor resections.