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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of early start visit [on average between 3-4 months after diagnosis]

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met