GliomaNCT04543201
Telehealth Visits to Discuss Advanced Directives for Patients Newly Diagnosed With High Grade Glioma
A study testing Early START visit using checklist over telephone or zoom in people with Glioma, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- Early START visit using checklist over telephone or zoom
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- New pathologic diagnosis of WHO grade III or IV glioma within four months of consent
- English speaking
Who cannot join
- Severe cognitive dysfunction or aphasia precluding discussion of advanced care planning issues
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jennifer Serventi, NP contact
United States1 site, 1 recruiting
- Recruiting
University of Rochester
Rochester, New York, 14642
Jessica Ellis, 5852752224, Sara_Hardy@URMC.Rochester.edu
About this study
Official title: Early Telehealth Visits for Discussion of Advanced Directives for Patients Newly Diagnosed With High Grade Glioma: Impact on Patient Care and Satisfaction
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.
Read the detailed description
High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. Discussion and documentation of an advance care plan are needed to achieve end of life goals that are concordant with a patient's wishes. Early cognitive dysfunction in brain tumor patients can impede patients from making decisions about their own care. Patients with HGG, therefore require discussion and documentation of end of life goals early in their disease course, but implementation of this has been elusive.
In this study, we will integrate an Early STructured Advanced care Referrals by Telehealth (Early START) visit into standard neuro-oncologic care prior to initiation of adjuvant chemotherapy in patients with HGG. Multi-disciplinary providers including physicians, advanced practice providers, and nurses will undergo an in-service by palliative care experts to perform Early START with a standardized checklist followed by periodic training sessions. Fifty patients with HGG will be enrolled over a 12-month period. They will receive a pre-visit educational guide to increase literacy regarding advance directives (AD) followed by a provider-led Early START visit that will be recorded. Post-visit assessments will address patient and caregiver perspectives on the intervention, patient and caregiver knowledge, patient satisfaction and patient-reported anxiety measures. A provider questionnaire will assess length of visit, adherence to the checklist and AD outcomes of the visit. Patients will be followed until death. End of life quality measures and concordance of death with goals of care will be assessed using a combination of caregiver surveys and the electronic medical record. These outcomes will be compared to historical controls treated at our center from 2010-2015.
Specific Aims:
Aim 1a. To determine the effectiveness of Early START as measured by AD documentation.
Aim 1b. To determine the utility of Early START as measured by timing of hospice enrollment at the end of life and place of death concordant with the patient's goals.
Hypothesis: As our primary aim, we hypothesize that Early START will increase the percentage of AD documentation by the 3rd oncology visit from 51% to 80%. As secondary outcomes, we hypothesize that it will decrease the percentage of AD that are completed by proxy from 45% to 25%, will improve end of life quality measures as compared to our published historical controls and that the majority of patients who undergo Early START will die in a setting of their choosing.
Aim 2a. To demonstrate the feasibility of Early START as measured by the percent of visits completed prior to the third oncology visit, adherence to a pre-specified checklist, and length of time to complete the visit.
Aim 2b. To optimize the Early START intervention by incorporating patient/caregiver and provider feedback.
Hypothesis: We hypothesize that 80% of visits will be completed using telehealth by the 3rd oncology visit, 80% of providers will utilize the pre-specified checklist and that average visit duration will be less than one hour.
- Conditions
- Glioma
- Being tested
- Early START visit using checklist over telephone or zoom
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early START visit using checklist over telephone or zoomBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Early START visit using checklist over telephone or zoom |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced Directive Completion Rate
Percentage of patients who complete an advanced directive by the third oncology visit
Measured: Time of diagnosis to 3rd oncology visit at an average of 4 months
Secondary outcomes (8)
Early START visit completion
Percentage of Early START (Early STructured Advanced care Referrals by Telehealth) visits completed by the third oncology visit
Measured: Time of diagnosis to 3rd oncology visit at an average of 4 months
Checklist use
Percentage of providers who use the checklist
Measured: Time of Early START visit [on average between 3-4 months after diagnosis]
Duration of visit
Duration of time in minutes
Measured: Duration of visit [average 60 min]
Advanced Care Directive Completion by patient vs proxy
Percentage of completed Advanced Care Directives completed by proxy (rather than by the patient)
Measured: Time of diagnosis to death up to 5 years after registration
Chemotherapy use at end of life
Percentage of patients that were treated with chemotherapy within 14 days of death
Measured: Time of diagnosis to death up to 5 years after registration
Hospice enrollment
Percentage of patients who were enrolled in hospice >7 days prior to death
Measured: Time of diagnosis to death up to 5 years after registration
Palliative care and/or hospice involvement at end of life
Percentage of patients who received a palliative care or hospice consult prior to death
Measured: Time of diagnosis to death up to 5 years after registration
Setting of end of life
Percentage of patients for whom setting of death was consistent with their wishes
Measured: Time of diagnosis to death up to 5 years after registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start8 Oct 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimish Mohile, University of Rochester
- Investigators
- Sara Hardy, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04543201
- Sponsor's protocol ID
- UBRT21040
- Status last verified
- Dec 2025
- First submitted
- 28 Aug 2020
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Telehealth Visits for Discussion of Advanced Directives for Patients Newly Diagnosed With High Grade Glioma: Impact on Patient Care and Satisfaction
- ClinicalTrials.gov ID
- NCT04543201
- Acronym / sponsor ID
- UBRT21040
- Conditions
- Glioma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. Discussion and documentation of an advance care plan are needed to achieve end of life goals that are concordant with a patient's wishes. Early cognitive dysfunction in brain tumor patients can impede patients from making decisions about their own care. Patients with HGG, therefore require discussion and documentation of end of life goals early in their disease course, but implementation of this has been elusive.
In this study, we will integrate an Early STructured Advanced care Referrals by Telehealth (Early START) visit into standard neuro-oncologic care prior to initiation of adjuvant chemotherapy in patients with HGG. Multi-disciplinary providers including physicians, advanced practice providers, and nurses will undergo an in-service by palliative care experts to perform Early START with a standardized checklist followed by periodic training sessions. Fifty patients with HGG will be enrolled over a 12-month period. They will receive a pre-visit educational guide to increase literacy regarding advance directives (AD) followed by a provider-led Early START visit that will be recorded. Post-visit assessments will address patient and caregiver perspectives on the intervention, patient and caregiver knowledge, patient satisfaction and patient-reported anxiety measures. A provider questionnaire will assess length of visit, adherence to the checklist and AD outcomes of the visit. Patients will be followed until death. End of life quality measures and concordance of death with goals of care will be assessed using a combination of caregiver surveys and the electronic medical record. These outcomes will be compared to historical controls treated at our center from 2010-2015.
Specific Aims:
Aim 1a. To determine the effectiveness of Early START as measured by AD documentation.
Aim 1b. To determine the utility of Early START as measured by timing of hospice enrollment at the end of life and place of death concordant with the patient's goals.
Hypothesis: As our primary aim, we hypothesize that Early START will increase the percentage of AD documentation by the 3rd oncology visit from 51% to 80%. As secondary outcomes, we hypothesize that it will decrease the percentage of AD that are completed by proxy from 45% to 25%, will improve end of life quality measures as compared to our published historical controls and that the majority of patients who undergo Early START will die in a setting of their choosing.
Aim 2a. To demonstrate the feasibility of Early START as measured by the percent of visits completed prior to the third oncology visit, adherence to a pre-specified checklist, and length of time to complete the visit.
Aim 2b. To optimize the Early START intervention by incorporating patient/caregiver and provider feedback.
Hypothesis: We hypothesize that 80% of visits will be completed using telehealth by the 3rd oncology visit, 80% of providers will utilize the pre-specified checklist and that average visit duration will be less than one hour.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early STructured Advanced care Referrals by Telehealth | Experimental | Behavioral: Early START visit using checklist over telephone or zoomEarly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- New pathologic diagnosis of WHO grade III or IV glioma within four months of consent
- English speaking
Key exclusion criteria (1 listed)
- Severe cognitive dysfunction or aphasia precluding discussion of advanced care planning issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early START visit using checklist over telephone or zoomPrior 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 | Behavioural | Early STructured Advanced care Referrals by Telehealth |
Primary outcome
Advanced Directive Completion Rate
Time frame: Time of diagnosis to 3rd oncology visit at an average of 4 months
Percentage of patients who complete an advanced directive by the third oncology visit
8 secondary outcomes
Early START visit completion
Time frame: Time of diagnosis to 3rd oncology visit at an average of 4 months
Checklist use
Time frame: Time of Early START visit [on average between 3-4 months after diagnosis]
Duration of visit
Time frame: Duration of visit [average 60 min]
Advanced Care Directive Completion by patient vs proxy
Time frame: Time of diagnosis to death up to 5 years after registration
Chemotherapy use at end of life
Time frame: Time of diagnosis to death up to 5 years after registration
Hospice enrollment
Time frame: Time of diagnosis to death up to 5 years after registration
Palliative care and/or hospice involvement at end of life
Time frame: Time of diagnosis to death up to 5 years after registration
Setting of end of life
Time frame: Time of diagnosis to death up to 5 years after registration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Serventi, NP contact
Sara Hardy, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early START visit using checklist over telephone or zoom in people with Glioma, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Hardy, MD (585-273-4096, Sara_Hardy@URMC.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced Directive Completion Rate (time frame: Time of diagnosis to 3rd oncology visit at an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.