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

This study has been completed.
Sponsor:
Collaborator:
Foundation for Informed Medical Decision Making
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00970788
First received: August 7, 2009
Last updated: April 28, 2012
Last verified: April 2012
  Purpose

A randomized controlled trial of a video decision aid in 50 patients with advanced brain cancer.


Condition Intervention
Advanced Brain Cancer
Behavioral: Video intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Pilot Study of Using Video Images in Advance Care Planning in Malignant Glioma Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • end of life preference at time of interview [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • uncertainty regarding end of life preference at time of interview [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
  • knowledge of end of life preference at time of interview [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: verbal group
Verbal description of goals of care.
Experimental: Video group
Video decision aid.
Behavioral: Video intervention
Video of goals of care

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Folstein mini mental status score of 23 or less
  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: NCT00970788

Locations
United States, Massachusetts
MGH
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Foundation for Informed Medical Decision Making
Investigators
Principal Investigator: Angelo Volandes, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Angelo E. Volandes, MD, Faculty, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00970788     History of Changes
Other Study ID Numbers: 2008-P-000826/6
Study First Received: August 7, 2009
Last Updated: April 28, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Brain Neoplasms
Glioma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on July 24, 2014