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Using Videos in Advance Care Planning for Patients With Advanced Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01241929
First received: November 15, 2010
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention
Advanced Cancer
 Behavioral: video decision aid

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 Patients With Advanced Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • preferences for CPR [ Time Frame: within one hour after oncology visit ] [ Designated as safety issue: No ]
    CPR preference after visit to oncologist


Secondary Outcome Measures:
  • knowledge of CPR [ Time Frame: baseline and post-intervention ] [ Designated as safety issue: No ]
    assess knowledge of CPR

  • stability of preferences [ Time Frame: after 6-8 weeks ] [ Designated as safety issue: No ]
    assess CPR preferences again

  • predictors of preferences [ Time Frame: post-intervention ] [ Designated as safety issue: No ]
    predictors of preferences for CPR


Estimated Enrollment: 150
Study Start Date: April 2009
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241929

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Angelo E. Volandes, MD, PI, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01241929     History of Changes
Other Study ID Numbers: 2008P000826
Study First Received: November 15, 2010
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
advanced cancer

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013