Trial record 1 of 1 for: NCT02375841

Previous Study | Return to List | Next Study

Coping With Glioblastoma: A Study of Communication Between Physicians, Patients, and Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT02375841

Recruitment Status : Recruiting

First Posted : March 3, 2015

Last Update Posted : August 29, 2018

See Contacts and Locations

Sponsor:

Collaborator:

Weill Medical College of Cornell University

Information provided by (Responsible Party):

Memorial Sloan Kettering Cancer Center

Study Description

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


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 2019
Estimated Study Completion Date :	February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Genetic and Rare Diseases Information Center resources: Glioblastoma Glioma Neuroepithelioma

U.S. FDA Resources

Groups and Cohorts

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

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

Primary Outcome Measures :

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)
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)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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


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

Locations


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


Principal Investigator:	Eli Diamond, MD	Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center This link exits the ClinicalTrials.gov site


Responsible Party:	Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT02375841 History of Changes
Other Study ID Numbers:	15-034
First Posted:	March 3, 2015 Key Record Dates
Last Update Posted:	August 29, 2018
Last Verified:	August 2018

Keywords provided by Memorial Sloan Kettering Cancer Center:


Communication Physicians Patients Caregivers 15-034

Additional relevant MeSH terms:


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

To Top