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)

Trial Summary

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 data supports the effectiveness of the treatment Early START visit using checklist over telephone or zoom for brain cancer?

Research shows that using checklists can improve care coordination and communication for patients with brain tumors, and video consultations have been effective for providing psychological support to cancer patients at home, suggesting that telehealth methods like Early START visits could be beneficial.12345

Is telehealth generally safe for use in cancer care?

Telehealth has been used safely in cancer care, allowing patients in remote areas to access specialized healthcare without significant safety concerns reported.678910

How is the Early START visit treatment for brain cancer different from other treatments?

The Early START visit treatment is unique because it uses telehealth (remote healthcare) to provide structured advanced care referrals through phone or video calls, which can improve coordination and communication for brain cancer patients. This approach is particularly beneficial for patients who have difficulty traveling or need frequent consultations, offering a flexible and accessible alternative to traditional in-person visits.111121314

What is the purpose of this trial?

High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. It is important for patients with HGG to discuss and document their wishes at the end of life. However, many of these patients experience early changes in cognition which impede their decision-making. For this reason, these patients should have early discussions with their providers. However, implementation of this remains challenging in clinical practice.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. A checklist and pre-visit guide were developed to help guide the visit for both the provider and patient. Providers will receive special training in running these visits. Caregivers and/or family members will be encouraged to participate. Visits will be done using video or telephone and recorded. For patients who do not have access to technology for these visits, it will be provided. After the visit, patients, caregivers and/or family who participated, and providers will fill out surveys to address feasibility of having these extra visits and improve the visits for future. Patients will be followed until death. Caregivers and/or family who participated will be asked about whether end of life was in line with the patient's wishes. We will also use the patient's medical record to assess other aspects of end of life. We will compare end of life outcomes with other similar patients treated at our center.

Research Team

SH

Sara Hardy, MD

Principal Investigator

University of Rochester

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Early STructured Advanced care Referrals by TelehealthExperimental Treatment1 Intervention
Early START visit using checklist over telephone or zoom: A telehealth visit conducted within 4 months of patient diagnosis, with the goal of encouraging patients to discuss and document their end-of-life wishes prior to the onset of cognitive impediments common among patients with late-stage high grade glioma.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials
883
Recruited
555,000+

Findings from Research

A newly developed care coordination checklist for patients with brain tumors was positively received by 15 clinicians, with 66.7% reporting it improved care delivery and communication among treatment teams.
The checklist aims to enhance the patient experience and ensure appropriate goal-setting and post-discharge services, addressing the unique challenges faced by this population in inpatient rehabilitation settings.
Strategies to improve the experience of patients with brain tumors in the inpatient rehabilitation setting: development of a care coordination checklist.Knowlton, SE., Shih, SL., Brizzi, K., et al.[2023]
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 pilot study found that video consultations for psychological support in cancer patients were as effective as face-to-face meetings, showing no difference in therapeutic alliance or anxiety relief between the two methods.
Patient satisfaction levels were similar for both video and in-person consultations, suggesting that video consultations can be a viable option for providing psychological care in home-based oncology settings.
[Controlled pilot study of the use of video-consultation for psychological support of cancer patients during home-based care].Martin, J., Baussant-Crenn, C., Ristori, A., et al.[2019]

References

Strategies to improve the experience of patients with brain tumors in the inpatient rehabilitation setting: development of a care coordination checklist. [2023]
European multidisciplinary tumor boards support cross-border networking and increase treatment options for patients with rare gynecological tumors. [2023]
[Controlled pilot study of the use of video-consultation for psychological support of cancer patients during home-based care]. [2019]
The community physician's involvement in clinical trials and home treatment. [2019]
The use of telemedicine in pre-surgical evaluation: a retrospective cohort study of a neurosurgical oncology practice. [2022]
Childhood cancer survivor care: development of the Passport for Care. [2021]
Teleoncology uptake in British Columbia. [2018]
Patterns of enrollment of infants with central nervous system tumours on cooperative group studies: a report from the Canadian Pediatric Brain Tumour Consortium. [2021]
Pediatric central nervous system tumor survivor and caregiver experiences with multidisciplinary telehealth. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
The Emergence of Virtual Tumor Boards in Neuro-Oncology: Opportunities and Challenges. [2022]
Telemedicine in Neuro-Oncology-An Evaluation of Remote Consultations during the COVID-19 Pandemic. [2023]
Raising the standard of brain cancer care. [2017]
A multidisciplinary neuro-oncological triage panel reduces the time to referral and treatment for patients with a brain tumor. [2022]
Pediatric cerebellar medulloblastoma and extraneural metastases: a case study. [2004]
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