Malignant GliomaNCT02023346
Prognostic Awareness and Patient-Physician Communication in Malignant Glioma
An observational study of Malignant Glioma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to learn more about the understanding patients with brain tumors have of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- surveys and cognitive tests
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be recruited from the inpatient Neurology service. Caregivers will be recruited from either the inpatient Neurology service (if they are physically present at the hospital at the time of the patient's consent to participate) or via telephone communication (if not physically present at the time of patient consent).
Who may be able to join
- Patient Inclusion Criteria
- Age greater than or equal to 18
- Diagnosis of any WHO grade III or IV glioma
- Admitted to the inpatient Neurology service
- Has had at least one outpatient visit with a neuro-oncologist at MSKCC Fluent in English
- Caregiver Inclusion Criteria
Show all 9Show fewer
- Age greater than or equal to 18
- Identified by the patient as a relative, friend, or partner with whom he or she has a significant relationship and who provides him or her physical or emotional assistance.
- The patient has himself or herself agreed to participate in this study
Who cannot join
- Patient Exclusion Criteria
- A patient will be excluded if the Glasgow Coma Scale is less than 15. The patient must be oriented to self, age, place, and year, and month.
- Aphasia precluding comprehension and verbalization of consent to participate
- Patients who cannot verbally demonstrate their understanding of the risks, benefits, and alternatives to participating in the study. This evaluation will take place for otherwise eligible and willing participants, and it will be performed by the NP or MD clinician who is obtaining informed consent and will be documented in the medical record.
- Caregiver Exclusion Criteria
- No eligible caregivers who can complete the brief assessment in person or via telephone will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Memoral Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The purpose of this study is to learn more about the understanding patients with brain tumors have of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors.
- Conditions
- Malignant Glioma
- Being tested
- surveys and cognitive tests
- Keywords
- Patient-Physician Communication, Brain cancer, 13-253
- Medical subject headings
- Glioma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveys and cognitive testsBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Malignant Glioma patients | This is a cross-sectional study of patients with MG who are admitted to the inpatient Neurology service at MSKCC. We anticipate that participants will be accrued over approximately 18-24 months. All patients with MG admitted to Neurology, will be screened for eligibility and willingness to participate in the study. Receives: Behavioral: surveys and cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure prognostic awareness
Prognostic awareness (PA) will be measured using the Chochinov Prognostic Awareness Scale. This scale classifies patients into three categories of awareness: full, limited, or no awareness.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion30 Oct 2018
- Study completion30 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eli Diamond, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023346
- Sponsor's protocol ID
- 13-253
- Status last verified
- Oct 2018
- First submitted
- 23 Dec 2013
- Last updated
- 1 Nov 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Awareness and Patient-Physician Communication in Malignant Glioma
- ClinicalTrials.gov ID
- NCT02023346
- Acronym / sponsor ID
- 13-253
- Conditions
- Malignant Glioma
- Keywords
- Patient-Physician Communication, Brain cancer, 13-253
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Oct 2018 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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.
The purpose of this study is to learn more about the understanding patients with brain tumors have of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Malignant Glioma patients | – | Behavioral: surveys and cognitive testsThis is a cross-sectional study of patients with MG who are admitted to the inpatient Neurology service at MSKCC. We anticipate that participants will be accrued over approximately 18-24 months. All patients with MG admitted to Neurology, will be screened for eligibility and willingness to participate in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the inpatient Neurology service. Caregivers will be recruited from either the inpatient Neurology service (if they are physically present at the hospital at the time of the patient's consent to participate) or via telephone communication (if not physically present at the time of patient consent).
Key inclusion criteria (9 listed)
- Patient Inclusion Criteria
- Age greater than or equal to 18
- Diagnosis of any WHO grade III or IV glioma
- Admitted to the inpatient Neurology service
- Has had at least one outpatient visit with a neuro-oncologist at MSKCC Fluent in English
Key exclusion criteria (6 listed)
- Patient Exclusion Criteria
- A patient will be excluded if the Glasgow Coma Scale is less than 15. The patient must be oriented to self, age, place, and year, and month.
- Aphasia precluding comprehension and verbalization of consent to participate
- Patients who cannot verbally demonstrate their understanding of the risks, benefits, and alternatives to participating in the study. This evaluation will take place for otherwise eligible and willing participants, and it will be performed by the NP or MD clinician who is obtaining informed consent and will be documented in the medical record.
- Caregiver Exclusion Criteria
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 |
|---|---|---|
| surveys and cognitive tests | Behavioural | Malignant Glioma patients |
Primary outcome
measure prognostic awareness
Time frame: 2 years
Prognostic awareness (PA) will be measured using the Chochinov Prognostic Awareness Scale. This scale classifies patients into three categories of awareness: full, limited, or no awareness.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Intratumoral Extracellular Metabolic Impact of DFMO and AMXT 1501 in Patients With Diffuse or High Grade Glioma
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Genetically Modified T-cells in Treating Patients With Recurrent or Refractory Malignant Glioma
Recurrent Glioblastoma, Recurrent Malignant Glioma
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A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
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RecruitingPhase 2
Entrectinib as a Single Agent in Upfront Therapy for Children <3 Years of Age With NTRK1/2/3 or ROS1-FUSED CNS Tumors
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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. This study is not recruiting at the moment.
Eli Diamond, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Glioma, run by Memorial Sloan Kettering Cancer Center 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 9 inclusion and 6 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: finished, as of the sponsor's last update on 1 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure prognostic awareness (time frame: 2 years). 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 1 Nov 2018.