Prognostic Awareness and Patient-Physician Communication in Malignant Glioma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT02023346
First received: December 23, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to learn more about patients with brain tumors understanding of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors.


Condition Intervention
Malignant Glioma
Behavioral: surveys and cognitive tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Awareness and Patient-Physician Communication in Malignant Glioma

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • measure prognostic awareness [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Prognostic awareness (PA) will be measured using the Chochinov Prognostic Awareness Scale. This scale classifies patients into three categories of awareness: full, limited, or no awareness.


Estimated Enrollment: 200
Study Start Date: December 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Malignant Glioma patients
This is a cross-sectional study of patients with MG who are admitted to the inpatient Neurology service at MSKCC. We anticipate that participants will be accrued over approximately 18-24 months. All patients with MG admitted to Neurology, except Dr. Eli Diamond's patients and respective caregivers, will be screened for eligibility and willingness to participate in the study.
Behavioral: surveys and cognitive tests

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will be recruited from the inpatient Neurology service.

Criteria

Inclusion Criteria:

Patient Inclusion Criteria

  • Age greater than or equal to 18
  • Diagnosis of any WHO grade III or IV glioma
  • Admitted to the inpatient Neurology service
  • Has had at least one outpatient visit with a neuro-oncologist at MSKCC Fluent in English

Caregiver Inclusion Criteria

  • Age greater than or equal to 18
  • 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 physical or emotional assistance.
  • The patient has himself or herself agreed to participate in this study

Exclusion Criteria:

Patient Exclusion Criteria

  • A patient will be excluded if the Glasgow Coma Scale is less than 15, with one exception: if the score is 14 because of disorientation to date only, as evaluated in the verbal assessment, the patient is eligible to participate. The patient must be oriented to self, age, place, and year, and month.
  • Aphasia precluding comprehension and verbalization of consent to participate
  • Is a patient of Dr. Eli Diamond
  • Patients who cannot verbally demonstrate their understanding of the risks, benefits, and alternatives to participating in the study. This evaluation will take place for otherwise eligible and willing participants, and it will be performed by the NP or MD clinician who is obtaining informed consent and will be documented in the medical record.

Caregiver Exclusion Criteria

  • No eligible caregivers who can complete the brief assessment in person will be excluded
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023346

Contacts
Contact: Eli Diamond, MD 212-639-7576
Contact: Lisa DeAngelis, MD 212-639-7123

Locations
United States, New York
Memoral Sloan Kettering Cancer Center Recruiting
New Yori, New York, United States, 10065
Contact: Eli Diamond, MD    212-639-7576      
Contact: Lisa DeAngelis, MD    212-639-7123      
Principal Investigator: Eli Diamond, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Eli Diamond, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02023346     History of Changes
Other Study ID Numbers: 13-253
Study First Received: December 23, 2013
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Patient-Physician Communication
Brain cancer
13-253

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 20, 2014