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The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria


N/A
18 Years
N/A
Open (Enrolling)
Both
Pancreas and Hepatobiliary Cancer Patients

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Trial Information

The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria


Inclusion Criteria:



- Primary pancreatic or hepatobiliary cancer (including ampullary carcinoma)as well as
gastric and/or esophageal cancers, excluding neuroendocrine histology

- Progressive disease: Locally advanced or metastatic disease with progression on at
least one course of treatment (surgery, radiation, or chemotherapy), or untreated
patients unfit for therapy because of comorbidities or ECOG performance status >2,
and finally, patients with ECOG performance status 2 -- patients must have discussed
on at least one occasion with the treating investigator oncologist that their cancer
cannot be cured

- In the estimation of the treating physician investigator, life expectancy ≤ 1 year

- Known to a GI medical oncology MSKCC clinic: Patients who have already established a
relationship with a GI medical oncologist (who is an investigator on this protocol)
after at least one new visit in the clinic (or as an in-patient), have MSKCC
pathologist confirmed cancer of an above histology, and express an initial intent to
be followed primarily at MSKCC

- English speaking*

- Able to provide informed consent

- Age greater than or equal to 18 years

- Do not have an advance directive or living will * English is the validated language
in one of the study tools, and the language in which information is communicated in
the narrative and video.

Exclusion Criteria:

- Short Portable Mental Status Questionnaire (SPMSQ) score of less than "intact mental
functioning" (3 or more errors). SPMSQ in appendix.

- Any patient psychological state deemed by the treating physician to pose any risk of
psychological harm by issues raised in a discussion of the trial, or in its testing
procedures. Any subject who may become upset during any aspect or discussion of the
study will be offered counseling services.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To document advance directive (AD)completion

Outcome Time Frame:

1 month post-test

Safety Issue:

No

Principal Investigator

Eileen O'Reilly, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

10-043

NCT ID:

NCT01105806

Start Date:

April 2010

Completion Date:

April 2014

Related Keywords:

  • Pancreas and Hepatobiliary Cancer Patients
  • advance directive
  • CPR Intervention
  • Video
  • Narrative
  • 10-043
  • Gastrointestinal Neoplasms

Name

Location

Memorial Sloan Kettering Cancer Center New York, New York  10021