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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Angelo E. Volandes, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00970125
First received: August 6, 2009
Last updated: April 28, 2012
Last verified: April 2012
  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: Open Label
Primary Purpose: Health Services Research
Official Title: Using Video Images to Improve Advance Care Planning in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • end of life preference at time of interview [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • knowledge [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]
  • decisional conflict [ Time Frame: 5 minutes after survey ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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, R21 CA 139121-01
Study First Received: August 6, 2009
Last Updated: April 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
advance care planning
cancer

ClinicalTrials.gov processed this record on November 24, 2014