Telehealth Visits to Discuss Advanced Directives for Patients Newly Diagnosed With High Grade Glioma

NCT04543201 | Recruiting DMC

• 1 other identifier: UBRT21040
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioma

Outcome Measures

Primary Outcomes (1)

• Advanced Directive Completion Rate

  Percentage of patients who complete an advanced directive by the third oncology visit

  Time of diagnosis to 3rd oncology visit at an average of 4 months

Secondary Outcomes (8)

• Early START visit completion

  Time of diagnosis to 3rd oncology visit at an average of 4 months

• Checklist use

  Time of Early START visit [on average between 3-4 months after diagnosis]

• Duration of visit

  Duration of visit [average 60 min]

• Advanced Care Directive Completion by patient vs proxy

  Time of diagnosis to death up to 5 years after registration

• Chemotherapy use at end of life

  Time of diagnosis to death up to 5 years after registration

Study Arms (1)

Early STructured Advanced care Referrals by Telehealth

EXPERIMENTAL

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.

Behavioral: Early START visit using checklist over telephone or zoom

Interventions

Early START visit using checklist over telephone or zoom BEHAVIORAL

Prior to visit subject receives pre-visit educational guide and copy of advance directive form Follow up surveys: Immediate: provider feedback survey 2-4 weeks after visit: subject feedback survey and caregiver/family feedback survey After subject death: caregiver/family survey

Early STructured Advanced care Referrals by Telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New pathologic diagnosis of WHO grade III or IV glioma within four months of consent
• English speaking

You may not qualify if:

• Severe cognitive dysfunction or aphasia precluding discussion of advanced care planning issues

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Sara Hardy, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Hardy, MD

CONTACT

585-273-4096; Sara_Hardy@URMC.rochester.edu

Jennifer Serventi, NP

CONTACT

Jennifer_Serventi@URMC.rochester.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 10, 2020
• Study Start: October 8, 2021
• Primary Completion: July 31, 2026
• Study Completion: July 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)