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N/A
21 Years
N/A
Open (Enrolling)
Both
Advanced Cancer

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Trial Information


Aim 1: To recruit 150 subjects with advanced cancer admitted to the inpatient oncology ward
with an overall prognosis of one year or less and randomly assign these subjects to:

1. a video visually depicting CPR preferences or

2. the current standard of care without the use of video (control).

Hypothesis 1: It is feasible to recruit and randomize 150 hospitalized subjects with
advanced cancer and an overall prognosis of one year or less.

Aim 2: To compare the care preferences for CPR and intubation among subjects randomized to
video and subjects randomized to the current standard of care without the video.

Hypothesis 2: Subjects randomized to the video intervention will be significantly more
likely to opt against CPR and intubation compared to those who do not see the video.

Aim 3: To compare code-status documentation in the electronic medical records between
subjects randomized to the video and those who are receiving the current standard of care
without the video.

Hypothesis 3: Subjects randomized to the video are more likely to have their code status
documented in the electronic medical records compared to those who do not see the video.

Aim 4: To compare the decisional conflict of subjects randomized to video and subjects
randomized to the current standard of care without the video.

Hypothesis 4: When compared to subjects randomized to the current standard of care, subjects
in the video intervention group will have lower decisional conflict (lower decisional
conflict scores) when asked to choose CPR and intubation preferences.

Aim 5: To compare knowledge assessment of CPR of subjects randomized to video and subjects
randomized to current standard of care without the video.

Hypothesis 5: When compared to subjects randomized to the current standard of care, subjects
in the video intervention group will have higher knowledge assessment scores when asked
questions regarding their understanding of CPR.

Aim 6: To compare code-status (CPR, and intubation) preferences in the electronic medical
record on future hospitalizations up to one year post-hospital discharge of subjects
randomized to video and subjects randomized to current standard of care without the video.

Hypothesis 6: Subjects randomized to the video are more likely to opt against CPR and
intubation in the future compared to those who do not see the video.


Inclusion Criteria:



- Potential subjects will be identified by the research assistant. The specific
eligibility criteria include:

1. Over the age of 60

2. The ability to provide informed consent

3. The ability to communicate in English

4. An established diagnosis of metastatic cancer with a prognosis of one year or
less confirmed with the attending physician on service.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

preferences for medical care regarding CPR (yes, no or unsure)

Outcome Time Frame:

within 5 minutes of surveyor asking the questions

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

2011P000010

NCT ID:

NCT01527331

Start Date:

June 2011

Completion Date:

Related Keywords:

  • Advanced Cancer
  • Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617