Coping With Glioblastoma: A Study of Communication Between Physicians, Patients, and Caregivers
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Hospital
-
-
New Jersey
-
Basking Ridge, New Jersey, United States, 07920
- Memorial Sloan Kettering Basking Ridge
-
Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, United States, 07645
- Memorial Sloan Kettering Bergen
-
-
New York
-
Commack, New York, United States, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- University of Vermont Medical Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patient Inclusion Criteria:
- 18 years or older
- Pathologic diagnosis of WHO grade IV glioma, as per MSKCC medical record or outside medical record.
- In the judgment of the consenting professional, proficiency in English that will allow the participant to be able to complete study questionnaires and assessments. Many of the study assessments are available only in English.
- At the time of consent, orientation to self, place, month and year
Caregiver Inclusion Criteria:
- 18 years or older
- 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 informal (unpaid) care (i.e., physical or emotional assistance).
- In the judgment of the consenting professional, proficiency in English that will allow to complete study questionnaires and assessments. Many of the study assessments are available only in English.
Oncologist Inclusion Criteria:
- Treating Neuro-Oncologist in the Department of Neurology
Exclusion Criteria:
Patient Exclusion Criteria:
- A patient will be excluded if in the opinion of his/her attending neuro-oncologist or the covering neuro-oncologist, he does not have the capacity to consent to the study based on clinical evaluation
- Aphasia precluding comprehension and verbalization of consent to participate, in the estimation of the attending physician.
Caregiver Exclusion Criteria:
- There are no caregiver exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Physicians, Patients, and Caregivers
This is a longitudinal study of patients with GBM with recurrent or multi-recurrent disease as determined by their neuro-oncologist (on the basis of clinical and/or radiological findings).
Patients will indicate a single caregiver who will consent separately and perform separate assessments.
The study assessments will evaluate the content of the discussion in which this change in disease status was communicated, as well as include patient-reported and caregiver-reported outcomes.
We intend to accrue 160 total participants (80 patients and 80 caregivers) with complete post-discussion visit follow-ups over 18-24 months.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of responses from patients, to 3 yes/no questions
Time Frame: 2 years
|
The curability of the patient's cancer (curability) The patient's prognosis (prognosis)The patient's goals of care should his/her condition worsen and he/she becomes critically ill (EOL)
|
2 years
|
|
number of responses from caregivers to 3 yes/no questions
Time Frame: 2 years
|
The curability of the patient's cancer (curability) The patient's prognosis (prognosis)The patient's goals of care should his/her condition worsen and he/she becomes critically ill (EOL)
|
2 years
|
|
number of responses from physicians to 3 yes/no questions
Time Frame: 2 years
|
The curability of the patient's cancer (curability) The patient's prognosis (prognosis)The patient's goals of care should his/her condition worsen and he/she becomes critically ill (EOL)
|
2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Eli Diamond, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Behavior
- Glioblastoma
- Brain Neoplasms
- Communication
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Behavioral Disciplines and Activities
- Psychological Tests
- Surveys and Questionnaires
- Psychometrics
Other Study ID Numbers
Other Study ID Numbers
- 15-034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.