A Pilot Study of Using Video Images in Advance Care Plann... | NCT00970788

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

NCT00970788

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

May 1, 2012Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Advanced Brain Cancer

Interventions

Video intervention

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Aug 7, 2009

First Submission Date that Met QC Criteria

Sep 1, 2009

First Posted Date

Sep 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2012

Last Update Posted Date

May 1, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Angelo E. Volandes, MD, Faculty, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Name	Class
Foundation for Informed Medical Decision Making	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
verbal group	No Intervention	Verbal description of goals of care.
Video group	Experimental	Video decision aid.	Behavioral: Video intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Video intervention	Behavioral	Video of goals of care	Video group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Angelo Volandes, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MGH		Boston	Massachusetts	02114	United States