Using Videos in Advance Care Planning for Patients With Advanced Cancer

July 9, 2012 updated by: Angelo E. Volandes, MD, Massachusetts General Hospital

A Pilot Study of Using Video Images in Advance Care Planning in Patients With Advanced Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A.1. Aim 1: To recruit 150 subjects with advanced cancer and randomly assign these subjects to one of two advance care planning (ACP) modalities: 1. a video visually depicting CPR (intervention) or 2. a verbal narrative describing the CPR.

Hypothesis 1: It is feasible to recruit and randomize 150 subjects with advanced cancer.

A.2. Aim 2: To compare the care preferences for CPR among 150 subjects randomized to video vs. verbal narrative intervention.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more likely to opt NOT to have CPR compared to those randomized to the verbal narrative.

A.3. Aim 3: To compare knowledge assessment of CPR for 150 subjects randomized to video vs. verbal narrative intervention.

Hypothesis 3: When compared to subjects randomized to the verbal narrative arm, subjects in the video group will have higher knowledge assessment scores when asked questions regarding their understanding of CPR.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 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.
  2. ability to provide informed consent,
  3. cognitive ability to participate in the study
  4. ability to communicate in English.

Exclusion Criteria:

  1. inability to make decisions,
  2. non-English speaking,
  3. new patient visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: video decision aid
Video decision aid arm
Behavioral: video decision aid
video of CPR
No Intervention: Usual Care -- Verbal Description Arm
Verbal description of CPR (i.e., without the video).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
preferences for CPR
Time Frame: within one hour after oncology visit
CPR preference after visit to oncologist
within one hour after oncology visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
knowledge of CPR
Time Frame: baseline and post-intervention
assess knowledge of CPR
baseline and post-intervention
stability of preferences
Time Frame: after 6-8 weeks
assess CPR preferences again
after 6-8 weeks
predictors of preferences
Time Frame: post-intervention
predictors of preferences for CPR
post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 16, 2010

Study Record Updates

Last Update Posted (Estimate)

July 10, 2012

Last Update Submitted That Met QC Criteria

July 9, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008P000826

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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