A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients

April 28, 2012 updated by: Angelo E. Volandes, MD, Massachusetts General Hospital
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer. Subjects will have three options for their goals of care: life prolonging care, basic medical care, or comfort care.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Advanced brain cancer
  • English Speaking
  • Able to provide informed consent

Exclusion Criteria:

  • Folstein mini mental status score of 23 or less

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: verbal group
Verbal description of goals of care.
Experimental: Video group
Video decision aid.
Behavioral: Video intervention
Video of goals of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
end of life preference at time of interview
Time Frame: 5 minutes after survey
5 minutes after survey

Secondary Outcome Measures

Outcome Measure
Time Frame
uncertainty regarding end of life preference at time of interview
Time Frame: 5 minutes after survey
5 minutes after survey
knowledge of end of life preference at time of interview
Time Frame: 5 minutes after survey
5 minutes after survey

Collaborators and Investigators

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

Sponsor

Massachusetts General Hospital

Collaborators

Foundation for Informed Medical Decision Making

Investigators

  • Principal Investigator: Angelo Volandes, MD, Massachusetts General Hospital

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

July 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

September 1, 2009

First Posted (Estimate)

September 2, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2012

Last Update Submitted That Met QC Criteria

April 28, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-P-000826/6

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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