NCT02023346

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

4.9 years

First QC Date

December 23, 2013

Last Update Submit

October 31, 2018

Conditions

Keywords

Patient-Physician CommunicationBrain cancer13-253

Outcome Measures

Primary Outcomes (1)

  • measure prognostic awareness

    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

Study Arms (1)

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

Interventions

Malignant Glioma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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.
  • No eligible caregivers who can complete the brief assessment in person or via telephone will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memoral Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

GliomaBrain Neoplasms

Interventions

Surveys and QuestionnairesNeuropsychological Tests

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Eli Diamond, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2013

First Posted

December 30, 2013

Study Start

December 1, 2013

Primary Completion

October 30, 2018

Study Completion

October 30, 2018

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations