NCT00970788

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

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

July 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2009

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

August 7, 2009

Last Update Submit

April 28, 2012

Conditions

Advanced Brain Cancer

Outcome Measures

Primary Outcomes (1)

  • end of life preference at time of interview

    5 minutes after survey

Secondary Outcomes (2)

  • uncertainty regarding end of life preference at time of interview

    5 minutes after survey

  • knowledge of end of life preference at time of interview

    5 minutes after survey

Study Arms (2)

verbal group

NO INTERVENTION

Verbal description of goals of care.

Video group

EXPERIMENTAL

Video decision aid.

Behavioral: Video intervention

Interventions

Video interventionBEHAVIORAL

Video of goals of care

Video group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Folstein mini mental status score of 23 or less

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MGH

Boston, Massachusetts, 02114, United States

Location

Study Officials

  • Angelo Volandes, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

August 7, 2009

First Posted

September 2, 2009

Study Start

July 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations

US(1)