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Trial record 1 of 1 for:    NCT02375841
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Coping With Glioblastoma: A Study of Communication Between Physicians, Patients, and Caregivers

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ClinicalTrials.gov Identifier: NCT02375841
Recruitment Status : Recruiting
First Posted : March 3, 2015
Last Update Posted : March 3, 2020
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to learn more about the way physicians communicate with brain tumor patients. This study will look at how oncologists provide information about brain tumors, brain scan results, and treatment options. This study will look at how oncologists provide information about brain tumors, brain scan results, and treatment options. Ultimately, the investigators hope to use these findings to improve communication between patients, caregivers and their doctors.

Condition or disease Intervention/treatment
Brain Cancer Glioblastoma Behavioral: psychometric tests, questionnaires and neurocognitive assessments

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Coping With Glioblastoma: A Study of Communication Between Physicians, Patients, and Caregivers
Actual Study Start Date : February 2015
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Groups and Cohorts
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Group/Cohort Intervention/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.
 Behavioral: psychometric tests, questionnaires and neurocognitive assessments


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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)

  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients with GBM will be screened in the outpatient clinic at MSKCC.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02375841


Contacts
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Contact: Eli Diamond, MD 212-639-7576
Contact: Allison Applebaum, PhD 646-888-0034

Locations
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United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Tobias Walbert, MD    800-436-7936      
Principal Investigator: Clara Hwang, MD         
United States, New Jersey
Memoral Sloan Kettering Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Eli Diamond, MD    212-610-0243      
Memorial Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Eli Diamond, MD    212-610-0243      
Memorial Sloan Kettering Bergen Recruiting
Montvale, New Jersey, United States, 07645
Contact: Eli Diamond, MD    212-610-0243      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Eli Diamond, MD    212-610-0243      
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Eli Diamond, MD    212-610-0243      
Memoral Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Eli Diamond, MD    212-610-0243      
Contact: Allison Applebaum, PhD    646-888-0034      
Principal Investigator: Eli Diamond, MD         
United States, Vermont
University of Vermont Medical Center Recruiting
Burlington, Vermont, United States, 05401
Contact: Alissa Thomas, MD    802-847-8400      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Eli Diamond, MD Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:
Memorial Sloan Kettering Cancer Center  This link exits the ClinicalTrials.gov site

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02375841    
Other Study ID Numbers: 15-034
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 3, 2020
Last Verified: March 2020
Keywords provided by Memorial Sloan Kettering Cancer Center:
Communication
Physicians
Patients
Caregivers
15-034
Additional relevant MeSH terms:
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Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases