Clinical trial NCT01105806: Cardiopulmonary Resuscitation (CPR) Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients
Official title: The Use of a CPR Video to Enhance Advance Care Planning in Advanced Upper Gastrointestinal Cancer Patients: A Randomized Controlled Pilot Tria
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreas and Hepatobiliary Cancer Patients
Keywords: advance directive
CPR Intervention
Video
Narrative
10-043
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Mount Sinai Hospital, New York
First posted: 2010-04-19
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be recruited from the MSKCC GI medical oncology group of listed study investigators, and as above, 18 years of age or older with no advance directive completed, and will be English speaking, due to the study tools being based in English.

Brief summary: Advance care planning involves thinking about choices if the patient becomes sick, and is important for everyone. It does not matter if the patients are ill or healthy. It is especially important for people who have diseases that cannot be cured. It allows people to make sure their wishes are respected if they become very sick or are dying. Thinking about these issues can be upsetting. But, for many people, it is helpful. This type of discussion can help the family learn what the patient may want but cannot tell them when these decisions need to be made


Eligibility criteria: 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.

Primary outcomes:
measure: To document advance directive (AD)completion
timeFrame: 1 month post-test
Secondary outcomes:
measure: To assess patient uncertainty about, knowledge of, and preference for CPR.
timeFrame: pre and post randomization
measure: To longitudinally follow discussions about ADs and nature of hospitalizations
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Eileen O'Reilly, MD
role: PRINCIPAL_INVESTIGATOR
References: