Back to resultsA Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
Primary Purpose
Advanced Brain Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Video intervention
Sponsored by
About this trial
This is an interventional health services research trial for Advanced Brain Cancer
Eligibility Criteria
Inclusion Criteria:
- Advanced brain cancer
- English Speaking
- Able to provide informed consent
Exclusion Criteria:
- Folstein mini mental status score of 23 or less
Sites / Locations
- MGH
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
verbal group
Video group
Arm Description
Verbal description of goals of care.
Video decision aid.
Outcomes
Primary Outcome Measures
end of life preference at time of interview
Secondary Outcome Measures
uncertainty regarding end of life preference at time of interview
knowledge of end of life preference at time of interview
Full Information
NCT ID
NCT00970788
First Posted
August 7, 2009
Last Updated
April 28, 2012
Sponsor
Massachusetts General Hospital
Collaborators
Foundation for Informed Medical Decision Making
1. Study Identification
Unique Protocol Identification Number
NCT00970788
Brief Title
A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
Official Title
A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Foundation for Informed Medical Decision Making
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Brain Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
verbal group
Arm Type
No Intervention
Arm Description
Verbal description of goals of care.
Arm Title
Video group
Arm Type
Experimental
Arm Description
Video decision aid.
Intervention Type
Behavioral
Intervention Name(s)
Video intervention
Intervention Description
Video of goals of care
Primary Outcome Measure Information:
Title
end of life preference at time of interview
Time Frame
5 minutes after survey
Secondary Outcome Measure Information:
Title
uncertainty regarding end of life preference at time of interview
Time Frame
5 minutes after survey
Title
knowledge of end of life preference at time of interview
Time Frame
5 minutes after survey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Advanced brain cancer
English Speaking
Able to provide informed consent
Exclusion Criteria:
Folstein mini mental status score of 23 or less
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angelo Volandes, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MGH
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients
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