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

March 1, 2024 updated by: Memorial Sloan Kettering Cancer Center
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

309

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

All patients with GBM will be screened in the outpatient clinic at MSKCC.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

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

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

Weill Medical College of Cornell University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

February 18, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimated)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.

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