NCT00970125

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 1, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

August 6, 2009

Last Update Submit

April 28, 2012

Conditions

Keywords

advance care planningcancer

Outcome Measures

Primary Outcomes (1)

  • end of life preference at time of interview

    5 minutes after survey

Secondary Outcomes (2)

  • knowledge

    5 minutes after survey

  • decisional conflict

    5 minutes after survey

Study Arms (1)

Cancer subjects

EXPERIMENTAL
Behavioral: video

Interventions

videoBEHAVIORAL

outline of the goals of care

Cancer subjects

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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).
  • English speaking. Only English-speaking patients will be included in our present study since English is the validated language of our study tools.
  • 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.
  • Able to provide informed consent.
  • Age greater than or equal to 21.

You may not qualify if:

  • MMSE \< 25.
  • Psychological state not appropriate for end-of-life discussion as determined by the treating clinician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Angelo E. Volandes, MD, MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

August 6, 2009

First Posted

September 2, 2009

Study Start

August 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 1, 2012

Record last verified: 2012-04

Locations