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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Behavioral: video

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering

Participation Criteria

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. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cancer subjects	Behavioral: video; outline of the goals of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
end of life preference at time of interview	5 minutes after survey

Secondary Outcome Measures

Outcome Measure	Time Frame
knowledge	5 minutes after survey
decisional conflict	5 minutes after survey

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Angelo E. Volandes, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: August 6, 2009
• First Submitted That Met QC Criteria: September 1, 2009
• First Posted (Estimate): September 2, 2009

Study Record Updates

• Last Update Posted (Estimate): May 1, 2012
• Last Update Submitted That Met QC Criteria: April 28, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: cancer; advance care planning
• Other Study ID Numbers: 2008-P-002156/2; R21CA139121-01 (U.S. NIH Grant/Contract)