NCT01241929

Brief Summary

To compare the decision making of subjects with advanced cancer having a verbal advance care planning discussion compared to subjects using a video.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration 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

April 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

2.8 years

First QC Date

November 15, 2010

Last Update Submit

July 9, 2012

Conditions

Keywords

advanced cancer

Outcome Measures

Primary Outcomes (1)

  • preferences for CPR

    CPR preference after visit to oncologist

    within one hour after oncology visit

Secondary Outcomes (3)

  • knowledge of CPR

    baseline and post-intervention

  • stability of preferences

    after 6-8 weeks

  • predictors of preferences

    post-intervention

Study Arms (2)

video decision aid

EXPERIMENTAL

Video decision aid arm

Behavioral: video decision aid

Usual Care -- Verbal Description Arm

NO INTERVENTION

Verbal description of CPR (i.e., without the video).

Interventions

video of CPR

video decision aid

Eligibility Criteria

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

You may qualify if:

  • diagnosis of cancer that falls under one of the following: A. All patients with brain cancer, inoperable hepatocellular/bile duct/gallbladder cancer, incurable non-small cell lung carcinoma (wet IIIb or IV), extensive stage small cell lung cancer, inoperable mesothelioma, inoperable pancreatic cancer or; metastatic gastric or esophageal cancer, metastatic melanoma, OR B. Patients with the following cancers, if first-line therapy has failed and limited response is expected to second-line therapy: breast cancer, colorectal cancer, head and neck cancer, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma, OR C. Less than one year prognosis.
  • ability to provide informed consent,
  • cognitive ability to participate in the study
  • ability to communicate in English.

You may not qualify if:

  • inability to make decisions,
  • non-English speaking,
  • new patient visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Volandes AE, Paasche-Orlow MK, Mitchell SL, El-Jawahri A, Davis AD, Barry MJ, Hartshorn KL, Jackson VA, Gillick MR, Walker-Corkery ES, Chang Y, Lopez L, Kemeny M, Bulone L, Mann E, Misra S, Peachey M, Abbo ED, Eichler AF, Epstein AS, Noy A, Levin TT, Temel JS. Randomized controlled trial of a video decision support tool for cardiopulmonary resuscitation decision making in advanced cancer. J Clin Oncol. 2013 Jan 20;31(3):380-6. doi: 10.1200/JCO.2012.43.9570. Epub 2012 Dec 10.

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
PI

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 16, 2010

Study Start

April 1, 2009

Primary Completion

January 1, 2012

Study Completion

April 1, 2012

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations