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Telehealth Consultations for Brain Cancer

N/A
Recruiting
Led By Sara Hardy, MD
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Severe cognitive dysfunction or aphasia precluding discussion of advanced care planning issues
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of diagnosis to death up to 5 years after registration
Awards & highlights

Summary

This trial will create an Early START visit for patients with high grade gliomas to discuss end of life wishes soon after their initial oncology visit. A checklist and pre-visit guide will be used to help guide the visit for both the provider and patient.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves discussions rather than medical treatments, there are no direct physical side effects. However, participants may experience emotional distress when discussing sensitive topics about end-of-life care.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot discuss my care plans due to severe cognitive issues or difficulty speaking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of early start visit [on average between 3-4 months after diagnosis]
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of early start visit [on average between 3-4 months after diagnosis] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Advanced Directive Completion Rate
Secondary study objectives
Advanced Care Directive Completion by patient vs proxy
Checklist use
Pharmacotherapy
+5 more

Trial Design

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 Location

Who is running the clinical trial?

University of RochesterLead Sponsor
859 Previous Clinical Trials
538,653 Total Patients Enrolled
Sara Hardy, MDPrincipal InvestigatorUniversity of Rochester

Media Library

Early START visit using checklist over telephone or zoom Clinical Trial Eligibility Overview. Trial Name: NCT04543201 — N/A
Brain Tumor Research Study Groups: Early STructured Advanced care Referrals by Telehealth
Brain Tumor Clinical Trial 2023: Early START visit using checklist over telephone or zoom Highlights & Side Effects. Trial Name: NCT04543201 — N/A
Early START visit using checklist over telephone or zoom 2023 Treatment Timeline for Medical Study. Trial Name: NCT04543201 — N/A
~19 spots leftby Jul 2026
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