Trial Summary
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.
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.
12345Is 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.
678910How 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.
111121314Eligibility 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.
Trial 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
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of RochesterRochester, NY
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Who Is Running the Clinical Trial?
University of RochesterLead Sponsor
References
Strategies to improve the experience of patients with brain tumors in the inpatient rehabilitation setting: development of a care coordination checklist. [2023]To develop a checklist to facilitate coordination of care and communication of patients with brain tumors and assess the benefit of the checklist using a quality improvement survey.
European multidisciplinary tumor boards support cross-border networking and increase treatment options for patients with rare gynecological tumors. [2023]To evaluate outcomes of European cross-border multidisciplinary tumor boards in terms of participation, adherence to treatment recommendations, and access to novel treatment strategies.
[Controlled pilot study of the use of video-consultation for psychological support of cancer patients during home-based care]. [2019]This controlled pilot study aimed to assess the use of video-consultation to realize psychological clinical consultations in oncology during home-based care. The use of video-consultation for psychological support of cancer patients had never been evaluated in the perspective of an implementation in health services.
The community physician's involvement in clinical trials and home treatment. [2019]The advances in outcome of children with cancer in the last four decades have been remarkable. The improvement, however, has not been uniform. It has recently been shown that the outcome of children with medulloblastoma treated at nonuniversity cancer centers has been less successful than those who were treated at the university cancer centers. Protocol treatment and location of treatment has been correlated with outcome in children with acute lymphocytic leukemia. Cooperative group protocols, used in the clinical setting of pediatric oncologists, with extensive resources and major referral center backup, have improved the prognosis of childhood ALL. Therefore, to improve outcome of pediatric cancer patients a multidisciplinary team at a center with partnership of community physician (CP) would be helpful. The CP can assume an extremely important role in shared management of children with cancer. Major involvement can be anticipated in areas including: chemotherapeutic treatment, immunization, infection surveillance and treatment, detection of disease recurrence, and late effects of cancer treatment. A CP could decrease the financial burden, and help alleviate the anxieties and emotional stresses placed upon the patients and parents. More importantly, the CP can facilitate home terminal care when necessary. These CP-referral center arrangements are of value to the CP, as well, through their educational and psychological benefits.
The use of telemedicine in pre-surgical evaluation: a retrospective cohort study of a neurosurgical oncology practice. [2022]To determine if there was a discrepancy between telemedicine versus in-person New Patient Visits (NPVs) regarding the conversion rate to operative and radiosurgery cases at a tertiary surgical neuro-oncology practice.
Childhood cancer survivor care: development of the Passport for Care. [2021]Survivors of childhood cancer are at risk of long-term adverse effects and late effects of the disease and/or its treatment. In response to national recommendations to improve evidence-based follow-up care, a web-based support system for clinical decision making, the Passport for Care (PFC), was developed for use at the point of care to produce screening recommendations individualized to the survivor. To date, the PFC has been implemented in over half of the nearly 200 clinics affiliated with the Children's Oncology Group across the USA. Most clinician users report that the PFC has been integrated into clinic workflows, and that it fosters improved conversations with survivors about the potential late effects a survivor might experience and about the screening and/or behavioural interventions recommended to improve health status. Furthermore, clinicians using the PFC have indicated that they adhered more closely to follow-up care guidelines. Perspectives on the challenges encountered and lessons learned during the development and deployment of the PFC are reviewed and contrasted with other nationwide approaches to the provision of guidance on survivor follow-up care; furthermore, the implications for the care of childhood cancer survivors are discussed.
Teleoncology uptake in British Columbia. [2018]Telehealth enables the delivery of specialized health care to patients living in isolated and remote regions. The purpose of this analysis is to determine the current uptake of teleoncology in mainland British Columbia. Patient appointment data was extracted from the Cancer Agency Information System (CAIS) for the 2009 calendar year. Three types of practitioners used teleoncology in 2009: Medical Oncologists, Genetic Counsellors and Medical Geneticists. In total, 712 telehealth encounters were conducted; Medical Oncologists conducted 595 encounters (83.6%), Genetic Counsellors conducted 112 encounters (15.7%) and Medical Geneticists conducted 5 encounters (0.7%). The most common oncology appointments were Gastro-Intestinal (11.4%) and Lymphoma (11.0%) follow-up appointments with a Medical Oncologist. Telehealth encounters were conducted by 46 individual health care providers however, a single Medical Oncologist conducted 418 encounters and this accounts for more than half (58.7%) of all telehealth appointments in 2009. Radiation Oncologists on the mainland up to this point are not using the technology. The Local Health Areas with the highest number of oncology telehealth appointments were: Kamloops: 203 encounters (34.1%), Penticton: 84 encounters (14.1%), Cranbrook: 58 encounters (9.7%) and the Southern Okanagan: 33 encounter (5.5%). Use of telehealth in rural and remote areas of BC is limited and there is significant room for growth. Further research will be required to identify barriers and restrictions to the use of telehealth in order to increase teleoncology adoption in British Columbia.
Patterns of enrollment of infants with central nervous system tumours on cooperative group studies: a report from the Canadian Pediatric Brain Tumour Consortium. [2021]In children under the age of 3, the most common solid tumours are brain tumors. Treatment for many of these patients includes surgery, chemotherapy and rarely radiation therapy. Many clinical trials have been performed in an attempt to establish the best treatment for these patients. Patients enrolled on clinical trials contribute to the establishment of the best therapy. We performed a national survey of all children less than the age of three with brain tumours and examined the contribution these patients made to clinical trials. A data bank was established using data collected from Canadian pediatric oncology centers on children less than age 3 diagnosed with brain tumours between 1990 and 2005. Data were collected on the use of adjunctive treatment after surgery, treatment on a protocol, reasons patients were not registered on a protocol, and reasons for discontinuation of therapy. From the 579 cases in the data bank, 302 (52%) patients were treated with further therapy after surgery. The use of further therapy after surgery was significantly higher in patients with cerebellar and brain stem tumors, patients who were over 1 year of age, patients with ependymal and embryonal tumors, and patients with high grade malignant tumors. Only 62 (21%) patients were enrolled on a protocol for therapy. No factor was significant for being enrolled on a protocol. Reasons for not being registered on a protocol were mainly that there was no open COG/POG/CCG study or the study was not open at the institution. The therapy was stopped because of completion of the protocol in 50% and because of disease progression in 34%. In Canada, about half of children under the age of 36 months with brain tumors are undergoing therapy following surgery for their malignancy but only a small fraction of them are enrolled on a clinical trial. There needs to be improved availability of clinical trials for these patients so that novel therapies can be evaluated and survival improved.
Pediatric central nervous system tumor survivor and caregiver experiences with multidisciplinary telehealth. [2023]Telehealth use to facilitate cancer survivorship care is accelerating; however, patient satisfaction and barriers to facilitation have not been studied amongst pediatric central nervous system (CNS) tumor survivors. We assessed the telehealth experiences of survivors and caregivers in the Pediatric Neuro-Oncology Outcomes Clinic at Dana-Farber/ Boston Children's Hospital.
The Emergence of Virtual Tumor Boards in Neuro-Oncology: Opportunities and Challenges. [2022]Background Virtual tumor board (VTB) platforms are an important aspect of cancer management. They enable easier access to a multidisciplinary team of experts. To deliver high-quality cancer care, it is necessary to coordinate numerous therapies and providers, share technical knowledge, and maintain open lines of communication among all professionals involved. The VTB is an essential tool in the diagnosis and treatment of brain cancer. For patients with glioma and brain metastases, multidisciplinary tumor board guidelines should guide diagnosis and therapy throughout the course of the illness. VTBs are an emerging resource across various cancer care networks in the United States. Methodology We performed a systematic search of all VTBs incorporating a platform designed for this specific role. We reviewed the records of the Genomet VTB, the Medical University of South Carolina (MUSC) VTB, and Xcures VTB. Summary data examined included the year of launch, demographics, characteristics of cases, average response time, advantages, and how they handle protected health information. Results Overall, 30% of VTBs examined were launched in 2017. All had a Health Insurance Portability and Accountability Act-compliant online environment. On a review of Xcures records, the median age of the female patients was 57 years and the median age of the male patients was 55 years. The data showed that 44% (4.4 out of every 10 patients) with a confirmed treatment chose the VTB integrated option. Overall, 76% of patients in the Xcures registry had primary central nervous system tumors, with at least 556 patients in the tumor registry which included 46% glioblastoma cases (96% primary, 4% secondary). In the MUSC VTB project, 112 thoracic tumor cases and nine neuro-oncology cases were reviewed. The tumor board met weekly, and the average response time was within 24 hours of case review and presentation. The Genomet VTB de-identifies all patient information; this is a virtual platform primarily focused on neuro-oncology cases. Cases involved a median of five specialists most commonly neuro-oncologists, neurosurgeons, radiation oncologists, molecular pathologists, and neuroradiologists. The case review revealed an age range of six months to 84 years (mean age = 44.5 years), with 69.6% males and 30.4% females, 43.5% glioblastomas, 8.7% adenocarcinomas, and 8.7% infratentorial tumors. The average response time observed in all cases was ≤24 hours. Conclusions VTBs allow for quicker expert analysis of cases. This has resulted in an accelerated number of cases reviewed with a shortened communication time. More studies are needed to gain additional insights into user engagement metrics.
Telemedicine in Neuro-Oncology-An Evaluation of Remote Consultations during the COVID-19 Pandemic. [2023]In order to minimize the risk of infections during the COVID-19 pandemic, remote video consultations (VC) experienced an upswing in most medical fields. However, telemedicine in neuro-oncology comprises unique challenges and opportunities. So far, evidence-based insights to evaluate and potentially customize current concepts are scarce. To fill this gap, we analyzed >3700 neuro-oncological consultations, of which >300 were conducted as VC per patients' preference, in order to detect how both patient collectives distinguished from one another. Additionally, we examined patients' reasons, suitable/less suitable encounters, VC's benefits and disadvantages and future opportunities with an anonymized survey. Patients that participated in VC had a worse clinical condition, higher grade of malignancy, were more often diagnosed with glioblastoma and had a longer travel distance (all p < 0.01). VC were considered a fully adequate alternative to face-to-face consultations for almost all encounters that patients chose to participate in (>70%) except initial consultations. Most participants preferred to alternate between both modalities rather than participate in one alone but preferred VC over telephone consultation. VC made patients feel safer, and participants expressed interest in implementing other telemedicine modalities (e.g., apps) into neuro-oncology. VC are a promising addition to patient care in neuro-oncology. However, patients and encounters should be selected individually.
Raising the standard of brain cancer care. [2017]Survival rates for people with brain cancer are poor, and some patients do not receive the specialist support they need. Nurse specialist Ingela Oberg calls for earlier diagnosis and improved access to nurse-led clinics and rehabilitation services.
A multidisciplinary neuro-oncological triage panel reduces the time to referral and treatment for patients with a brain tumor. [2022]Regional collaboration and appropriate referral management are crucial in neuro-oncological care. Lack of electronic access to medical records across health care organizations impedes interhospital consultation and may lead to incomplete and delayed referrals. To improve referral management, we have established a multidisciplinary neuro-oncological triage panel (NOTP) with digital image exchange and determined the effects on lead times, costs, and time investment.
Pediatric cerebellar medulloblastoma and extraneural metastases: a case study. [2004]Brain tumors, the most common solid tumors affecting children, account for nearly 20% of all pediatric neoplasms. They occur second in incidence only to leukemia and are the leading cause of cancer-related death in children under 15 years of age. Of the many different brain tumors, medulloblastoma is one of the most common, accounting for 20% of all intracranial neoplasm. Once a reportable event, extraneural metastases of this tumour now occur at a rate of 7% and reports suggest the prevalence may be increasing. These children represent a major therapeutic challenge, that for optimal results require the coordinated efforts of a multidisciplinary approach. The nurse may play a vital role in the mobilization and coordination of many specialists. The intent of this case study is to highlight the essential link in the role of the nurse as a facilitator, coordinator and liaison, within the context of caring for a child with a malignant brain tumour.