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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02375841
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Eli Diamond, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain Cancer, Glioblastoma
Study Website: View Trial Website
Arms & Interventions

Arms

: 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.

Interventions

Behavioral: - psychometric tests, questionnaires and neurocognitive assessments

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Henry Ford Hospital, Detroit, Michigan

Status

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey

Status

Address

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920

Memorial Sloan Kettering Monmouth, Middletown, New Jersey

Status

Address

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748

Memorial Sloan Kettering Bergen, Montvale, New Jersey

Status

Address

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645

Memorial Sloan Kettering Commack, Commack, New York

Status

Address

Memorial Sloan Kettering Commack

Commack, New York, 11725

Memorial Sloan Kettering Westchester, Harrison, New York

Status

Address

Memorial Sloan Kettering Westchester

Harrison, New York, 10604

Memorial Sloan Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

University of Vermont Medical Center, Burlington, Vermont

Status

Address

University of Vermont Medical Center

Burlington, Vermont, 05401

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