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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00970125
Other study ID # 2008-P-002156/2
Secondary ID R21CA139121-01
Status Completed
Phase N/A
First received August 6, 2009
Last updated April 28, 2012
Start date August 2009
Est. completion date June 2011

Study information

Verified date April 2012
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 21 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
video
outline of the goals of care

Locations

Country Name City State
United States Memorial Sloan Kettering New York New York

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary end of life preference at time of interview 5 minutes after survey No
Secondary knowledge 5 minutes after survey No
Secondary decisional conflict 5 minutes after survey No
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