50 Participants Needed

Telehealth Consultations for Brain Cancer

SH
JS
Overseen ByJennifer Serventi, NP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Rochester
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals with high-grade gliomas, a type of fast-growing brain tumor, in discussing and documenting their end-of-life wishes early. It includes an Early START visit using a structured checklist via telephone or Zoom, enabling patients to communicate their preferences with healthcare providers before cognitive issues arise. Patients diagnosed with WHO grade III or IV glioma within the last four months who can speak English may be suitable candidates. The trial will evaluate the effectiveness of these discussions and their alignment with patients' end-of-life wishes. As an unphased trial, it provides a unique opportunity for patients to actively shape their care and ensure their wishes are respected.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this telehealth protocol is safe for patients with high grade gliomas?

Research shows that discussing end-of-life care through telehealth visits, such as the Early START visit, is generally well-received. These discussions occur over the phone or via video, eliminating concerns about physical side effects. The main goal is to communicate and plan, aiding patients and their families in making informed decisions.

Studies in similar contexts have explored patients' and caregivers' feelings about these conversations. They often find them helpful and supportive, especially when facing difficult decisions about future care. This indicates no major safety concerns with the Early START visit itself. Participants typically value the opportunity to express their wishes clearly and early.12345

Why are researchers excited about this trial?

Researchers are excited about using telehealth consultations for brain cancer because it offers a novel way to address patient needs early in their diagnosis. Unlike traditional in-person consultations that might occur later in the treatment process, this approach leverages telehealth to encourage discussions about end-of-life wishes soon after diagnosis, before cognitive decline becomes a barrier. This method could empower patients by providing a convenient and timely opportunity to make important decisions, potentially improving their overall care experience and quality of life.

What evidence suggests that the Early START visit is effective for high grade glioma patients?

Research has shown that the Early STructured Advanced care Referrals by Telehealth (Early START) visit, which participants in this trial will receive, is a promising method for patients with high-grade gliomas (HGGs). Early START enables patients to discuss and document their end-of-life wishes before cognitive issues hinder decision-making. Early findings suggest that this telehealth approach is practical and can enhance early planning and documentation of patient preferences. Patients and caregivers have found this method helpful, as it supports more independent decision-making. A checklist and guide keep the discussions clear and organized.12367

Who Is on the Research Team?

SH

Sara Hardy, MD

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for English-speaking patients who have been newly diagnosed with high-grade gliomas (WHO grade III or IV) within the past four months. It's not suitable for those with severe cognitive dysfunction or aphasia that would prevent them from discussing end-of-life care plans.

Inclusion Criteria

I was diagnosed with a high-grade brain tumor recently.
English speaking

Exclusion Criteria

I cannot discuss my care plans due to severe cognitive issues or difficulty speaking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early START Visit

A telehealth visit conducted to discuss and document end-of-life wishes using a checklist, within 4 months of diagnosis

3-4 months
1 visit (telehealth)

Follow-up

Participants are monitored for end-of-life quality measures and concordance with goals of care until death

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Early START visit using checklist over telephone or zoom
Trial Overview The study tests an 'Early START' program where patients use telehealth services like phone or Zoom to discuss their end-of-life wishes using a checklist and guide, soon after diagnosis. Providers are trained for these visits, which include family members, and technology is provided if needed.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Early STructured Advanced care Referrals by TelehealthExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Published Research Related to This Trial

Virtual tumor boards (VTBs) significantly enhance the speed and efficiency of cancer care, with an average response time of less than 24 hours for case reviews, allowing for quicker expert analysis and decision-making.
In a review of the Xcures VTB, 76% of patients had primary central nervous system tumors, and 44% of those with confirmed treatments opted for the VTB integrated option, highlighting its importance in managing complex cases like glioblastoma.
The Emergence of Virtual Tumor Boards in Neuro-Oncology: Opportunities and Challenges.Ekhator, C., Kesari, S., Tadipatri, R., et al.[2022]
Over a 3-year period, 31 multidisciplinary tumor boards were conducted involving 91 patients across 10 countries, leading to a remarkable adherence rate of 99% to treatment recommendations.
The tumor boards facilitated access to off-label treatments for 11 patients and enabled one patient to enroll in a clinical trial in another country, highlighting the potential for improved patient outcomes through international collaboration.
European multidisciplinary tumor boards support cross-border networking and increase treatment options for patients with rare gynecological tumors.Joneborg, U., Bergamini, A., Wallin, E., et al.[2023]
A study of 206 patients found that telemedicine new patient visits (NPVs) resulted in a surgical conversion rate of 33.6%, which is comparable to the 34.5% rate from in-person visits, indicating that telemedicine is equally effective for planning surgical interventions.
The analysis showed no significant differences in patient demographics or treatment timelines between telemedicine and in-person visits, supporting the conclusion that telemedicine can effectively facilitate complex neurosurgical care.
The use of telemedicine in pre-surgical evaluation: a retrospective cohort study of a neurosurgical oncology practice.Smit, RD., Mouchtouris, N., Reyes, M., et al.[2022]

Citations

Telehealth Visits to Discuss Advanced Directives for ...In this study, we will integrate an Early STructured Advanced care Referrals by Telehealth (Early START) visit into standard neuro-oncologic care prior to ...
Telehealth Visits to Discuss Advanced Directives for ...In this study, we will create an Early STructured Advanced care Referrals by Telehealth (Early START) visit for patients soon after their ...
A Prospective Study of Early Advanced Care Planning by ...Early START, an innovative care model of ACP by telehealth, is feasible, enhances early and autonomous ACP and AD documentation, and is highly valued by pGBM, ...
Telehealth Consultations for Brain CancerIn this study, we will create an Early STructured Advanced care Referrals by Telehealth (Early START) visit for patients soon after their initial oncology visit ...
Telehealth Visits to Discuss Advanced Directives for ...In this study, we will create an Early STructured Advanced care Referrals by Telehealth (Early START) visit for patients soon after their initial oncology visit ...
Current and bereaved caregivers' experiences of participating ...This study explored current and bereaved caregivers' reasons for seeking psychological support in the context of high-grade glioma and reports ...
Early mobilization in postoperative glioma patients real world ...Our findings show that an early mobilization protocol can promote early recovery in patients undergoing glioma resection without adversely affecting long-term ...
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