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Using Video Images to Improve Advance Care Planning in Patients With Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970125
First Posted: September 2, 2009
Last Update Posted: May 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
  Purpose
The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone.

Condition Intervention
Advanced Cancer Behavioral: video

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Using Video Images to Improve Advance Care Planning in Patients With Cancer

Further study details as provided by Angelo E. Volandes, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • end of life preference at time of interview [ Time Frame: 5 minutes after survey ]

Secondary Outcome Measures:
  • knowledge [ Time Frame: 5 minutes after survey ]
  • decisional conflict [ Time Frame: 5 minutes after survey ]

Enrollment: 80
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cancer subjects Behavioral: video
outline of the goals of care

Detailed Description:
The purpose of this study is to study whether preferences for the goals of care for 80 subjects with end-stage cancer are altered after viewing a video outlining the goals of care compared to their initial preferences after hearing a verbal description of the goals of care alone. Subjects will choose among three goals of care, life prolonging care, basic medical care, and comfort care.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Terminal, progressive cancer with poor prognosis whose treatment intent is palliative, based on the following definition:

    • All patients with brain cancer, liver cancer, inoperable non-small cell lung carcinoma, pancreatic cancer, or gallbladder cancer; OR
    • Patients with the following cancers: metastatic colon cancer or stage III or IV non-small cell lung cancer; OR
    • 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, stomach cancer, esophageal cancer, melanoma, leukemia, ovarian cancer, prostate cancer, renal cancer, sarcoma, lung cancer, myeloma, or lymphoma.
    • The terms terminal, progressive, poor prognosis, palliative intent and limited response will be judged by the patient's oncologist (and not by the RSA or consenting professional).
  2. Return patient visit (defined as a patient known to the oncologist from previous assessments and treatments, where the working and personal relationship has been established and not a new patient to the clinic).
  3. English speaking. Only English-speaking patients will be included in our present study since English is the validated language of our study tools.
  4. Given the sensitive nature of the study, clinicians will decide whether the patient is a potentially appropriate subject based on their knowledge of the patient.
  5. Able to provide informed consent.
  6. Age greater than or equal to 21.

Exclusion Criteria:

  1. MMSE < 25.
  2. Psychological state not appropriate for end-of-life discussion as determined by the treating clinician.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970125


Locations
United States, New York
Memorial Sloan Kettering
New York, New York, United States, 10065
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Angelo E. Volandes, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: Angelo E. Volandes, MD, Faculty, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00970125     History of Changes
Other Study ID Numbers: 2008-P-002156/2
R21CA139121-01 ( U.S. NIH Grant/Contract )
First Submitted: August 6, 2009
First Posted: September 2, 2009
Last Update Posted: May 1, 2012
Last Verified: April 2012

Keywords provided by Angelo E. Volandes, MD, Massachusetts General Hospital:
advance care planning
cancer