Prognostic Awareness and Patient-Physician Communication in Malignant Glioma

October 31, 2018 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to learn more about the understanding patients with brain tumors have of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

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
    • New York
      • New York, New York, United States, 10065
        • Memoral Sloan Kettering Cancer 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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited from the inpatient Neurology service. Caregivers will be recruited from either the inpatient Neurology service (if they are physically present at the hospital at the time of the patient's consent to participate) or via telephone communication (if not physically present at the time of patient consent).

Description

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. The patient must be oriented to self, age, place, and year, and month.
  • Aphasia precluding comprehension and verbalization of consent to participate
  • 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 or via telephone will be excluded

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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, will be screened for eligibility and willingness to participate in the study.
Behavioral: surveys and cognitive tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure prognostic awareness
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

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

Sponsor

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)

December 1, 2013

Primary Completion (Actual)

October 30, 2018

Study Completion (Actual)

October 30, 2018

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (Estimate)

December 30, 2013

Study Record Updates

Last Update Posted (Actual)

November 1, 2018

Last Update Submitted That Met QC Criteria

October 31, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-253

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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